title: Efficacy of oral doxepin and piroxicam treatment for interstitial cystitis. Cyclosporine A and pentosan polysulfate sodium for the treatment of interstitial cystitis: a randomized comparative study. A Pilot Open Label Study of Cystoprotek® in Interstitial Cystitis Treatment of interstitial cystitis with a quercetin supplement. Association between response to pentosan polysulfate sodium therapy for interstitial cystitis and patient questionnaire-based treatment satisfaction* Cyclosporine in severe interstitial cystitis. Two-year efficacy and safety of botulinum a toxin intravesical injections in patients affected by refractory painful bladder syndrome. Botulinum toxin a has antinociceptive effects in treating interstitial cystitis. A pilot clinical trial of oral pentosan polysulfate and oral hydroxyzine in patients with interstitial cystitis. Bladder Pain Syndrome Treated with Triple Therapy with Gabapentin, Amitriptyline, and a Nonsteroidal Anti-Inflammatory Drug Proof of concept trial of tanezumab for the treatment of symptoms associated with interstitial cystitis. The efficacy of intravesical bacillus Calmette-Guerin in the treatment of interstitial cystitis: long-term followup. A quantitatively controlled method to study prospectively interstitial cystitis and demonstrate the efficacy of pentosanpolysulfate. Safety and efficacy of the use of intravesical and oral pentosan polysulfate sodium for interstitial cystitis: a randomized double-blind clinical trial. Long-term results of amitriptyline treatment for interstitial cystitis. A pilot study of botulinum toxin A for male chronic pelvic pain syndrome Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome Safety and efficacy of hyperbaric oxygen therapy for the treatment of interstitial cystitis: a randomized, sham controlled, double-blind trial. Clinical Response to an Oral Prostaglandin Analogue in Patients with Interstitial Cystitis A placebo-controlled study of intravesical pentosanpolysulphate for the treatment of interstitial cystitis. Pentosan polysulfate sodium for therapy of interstitial cystitis. A double-blind placebo-controlled clinical study. Long-term experience with pentosanpolysulfate in interstitial cystitis. Hydroxyzine therapy for interstitial cystitis. Multiple Intravesical Instillations of Low-Dose Resiniferatoxin in the Treatment of Refractory Interstitial Cystitis Intravesical resiniferatoxin for the treatment of hypersensitive disorder: a randomized placebo controlled study. A randomized double‐blind placebo‐controlled crossover trial of the efficacy of l‐arginine in the treatment of interstitial cystitis Multimodal therapy for painful bladder syndrome / interstitial cystitis: pilot study combining behavioral, pharmacologic, and endoscopic therapies. A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis. Modified Thiele massage as therapeutic intervention for female patients with interstitial cystitis and high-tone pelvic floor dysfunction. Successful downregulation of bladder sensory nerves with combination of heparin and alkalinized lidocaine in patients with interstitial cystitis. Randomized, double-blind, dose-ranging study of pentosan polysulfate sodium for interstitial cystitis. Analysis of long-term Elmiron therapy for interstitial cystitis. Clinical and immunological response to nifedipine for the treatment of interstitial cystitis. A real‐life multicentre clinical practice study to evaluate the efficacy and safety of intravesical chondroitin sulphate for the treatment of interstitial cystitis The efficacy of intravesical Tice strain bacillus Calmette-Guerin in the treatment of interstitial cystitis: a double-blind, prospective, placebo controlled trial. Followup of patients with interstitial cystitis responsive to treatment with intravesical bacillus Calmette-Guerin or placebo. A rational combination of intravesical and systemic agents for the treatment of interstitial cystitis Intravesical Bacillus Calmette-Guerin for treatment of refractory interstitial cystitis. Use of the neodymium: YAG laser for interstitial cystitis: a prospective study. Effect of amitriptyline on symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome. Intravesical bacillus Calmette-Guerin and dimethyl sulfoxide for treatment of classic and nonulcer interstitial cystitis: a prospective, randomized double-blind study. Intravesical instillation of hyaluronic acid prolonged the effect of bladder hydrodistention in patients with severe interstitial cystitis. Improvement in interstitial cystitis symptom scores during treatment with oral L-arginine. Pilot study of sequential oral antibiotics for the treatment of interstitial cystitis. Botulinum A toxin intravesical injections for painful bladder syndrome: impact upon pain, psychological functioning and Quality of Life. Sacral neuromodulation for the symptomatic treatment of refractory interstitial cystitis: a prospective study. Short-term results of bilateral S2-S4 sacral neuromodulation for the treatment of refractory interstitial cystitis, painful bladder syndrome, and chronic pelvic pain. Interstitial cystitis: bladder training with intravesical oxybutynin. Improvement of interstitial cystitis symptoms and problems that developed during treatment with oral IPD-1151T. Intravesical liposome versus oral pentosan polysulfate for interstitial cystitis/painful bladder syndrome. Oral cimetidine gives effective symptom relief in painful bladder disease: a prospective, randomized, double‐blind placebo‐controlled trial Botulinum A toxin intravesical injection in patients with painful bladder syndrome: 1-year followup. A randomized double-blind trial of oral L-arginine for treatment of interstitial cystitis. The dual serotonin and noradrenaline reuptake inhibitor duloxetine for the treatment of interstitial cystitis: results of an observational study. Time to initiation of pentosan polysulfate sodium treatment after interstitial cystitis diagnosis: effect on symptom improvement. A multicenter, randomized, double-blind, parallel group pilot evaluation of the efficacy and safety of intravesical sodium chondroitin sulfate versus vehicle control in patients with interstitial cystitis/painful bladder syndrome.
abstract: OBJECTIVE To establish the efficacy of a multidrug oral treatment with the tricyclic antidepressant agent doxepin and the cyclooxygenase ( COX ) inhibitor piroxicam in patients with interstitial cystitis ( IC ) , who had failed st and ard therapy in an open , prospect i ve , nonr and omized study . METHODS A total of 37 patients diagnosed with IC received 75 mg doxepin and 40 mg piroxicam daily . The treatment was termed DOXCAM .  Effectiveness of therapy was assessed with frequency-volume charts , an IC symptom score and with cystometry prior to treatment , 8 weeks after the start and 4 weeks after termination of drug treatment . RESULTS Medication was not tolerated by five patients . Twenty-six of 32 patients have experienced virtual total remission of symptoms ( 81 % ) and six patients had significant relief ( 19 % ) . DOXCAM treatment result ed in a significant percent decrease in pain ( 65 % versus 21 % ) . Daytime frequency decreased from 17.6+/-5.7 to 11.3+/-3.6 voids while nocturia did not improve significantly . Twenty-three of the 26 patients who became symptom free and four of the six patients who showed significant improvement had a return of symptoms after cessation of therapy . CONCLUSION It is reasonable to consider oral treatment with DOXCAM in those patients who have failed first-line therapies PURPOSE In a previous retrospective analysis , cyclosporine A ( CyA ) was highly efficient in treating patients with interstitial cystitis . A prospect i ve r and omized study with this immunosuppressive agent was warranted . We compared CyA to pentosan polysulfate sodium ( PPS ) in patients with interstitial cystitis . MATERIAL S AND METHODS A total of 64 patients with interstitial cystitis meeting the National Institute of Diabetes and Digestive and Kidney Diseases criteria were enrolled in a r and omized prospect i ve study . Patients were r and omized in a 1:1 ratio to 1.5 mg/kg CyA twice daily ( 27 women , 5 men ) or 100 mg PPS 3 times daily ( 26 women , 6 men ) for a period of 6 months . The primary end point was daily micturition frequency , and secondary end points were mean and maximal voided volume , number of nocturia episodes , O'Leary-Sant symptom and problem indexes , visual analogue scale for pain , and subjective global response assessment . RESULTS CyA was superior to PPS in all clinical outcome parameters measured at 6 months . Micturition frequency in 24 hours was significantly reduced in the CyA arm compared to the PPS arm ( -6.7 + /- 4.7 vs -2.0 + /- 5.1 times ) . The clinical response rate ( according to global response assessment ) was 75 % for CyA compared to 19 % for PPS ( p < 0.001 ) . Although there were more adverse events in the CyA arm than in the PPS arm , 29 patients completed the 6-month followup in both groups . CONCLUSIONS CyA is more effective than PPS in interstitial cystitis Interstitial cystitis ( IC ) is a disorder of the urinary bladder characterized by urgency , frequency , nocturia and suprapubic pain . IC occurs primarily in women and symptoms are exacerbated by stress , ovulatory hormones and certain foods . IC pathogenesis is unknown , but the most consistent findings involve some dysfunction of the bladder glycosaminoglycan ( GAG ) protective layer and a high number of activated bladder mast cells . There is no effective therapy even through intravesical administration of dimethylsulfoxide ( DMSO ) or oral pentosanpolysulfate ( PPS ) have had variable success . A dietary supplement , CystoProtek ® , was formulated with the natural GAG components chondroitin sulfate and sodium hyaluronate to provide urothelial cytoprotection , together with the flavonoid quercetin that has anti-inflammatory properties and inhibits activation of mast cells . Thirty-seven female patients diagnosed by the NIDDK criteria who had failed all forms of therapy  took six softgel CystoProtek ® capsules per day for 6 months . Global assessment scale was reduced from 9.0 ± 2.9 to 4.3 ± 2.1 ( p < 0.05 ) ; moreover , the O'Leary/Sant Symptom Index decreased from 16.3 ± 3.1 to 6.9 ± 4.2 ( p < 0.05 ) and the Problem Index from 13.1 ± 3.7 to 5.4 ± 4.0 ( p < 0.05 ) . These results are very promising and warrant a larger study that may permit further analyses with respect to other , especially atopic , comorbid diseases PURPOSE Interstitial cystitis ( IC ) is a disorder of unknown etiology with few effective therapies . Oral bioflavonoid therapy utilizing quercetin recently proved to be clinical ly effective in men with chronic pelvic pain syndrome , a disorder with similarities to IC . We therefore tested in an open-label trial a quercetin-based supplement in patients with clinical ly proven IC . MATERIAL S AND METHODS Twenty-two patients ( 5 men and 17 women ; average age 53.1 years ) with classically documented IC received  one capsule of Cysta-Q complex ( equivalent to 500 mg of quercetin ) twice a day for 4 weeks . Symptoms were assessed before and after therapy by the IC problem and symptom indices as well as by global assessment of pain ( range 0 - 10 ) . RESULTS Two patients did not complete the study . In the remaining 20 patients , improvement was seen in all three parameters tested . After 4 weeks of treatment , the mean ( + /- SEM ) problem index improved from 11.3 + /- 0.6 to 5.1 + /- 0.7 ( p = .000001 ) , the mean symptom index improved from 11.9 + /- 0.9 to 4.5 + /- 0.5 ( p = .000001 ) , and the mean global assessment score improved from 8.2 + /- 0.4 to 3.5 + /- 0.4 ( p = .000001 ) . None of the patients experienced any negative side effects , and all but one patient had at least some improvement in every outcome measure . CONCLUSION Oral therapy with the quercetin supplement Cysta-Q was well tolerated and provided significant symptomatic improvement in patients with IC . Larger , r and omized , placebo-controlled trials appear warranted based on these preliminary open-label results ABSTRACT Objective : To evaluate the relationship between symptom reduction and satisfaction with pentosan polysulfate sodium ( PPS ) therapy in subjects with interstitial cystitis ( IC ) . Methods : A secondary analysis was conducted in 128 subjects treated with PPS 300 mg/day ( US Food and Drug Administration-approved dose ) from a 32-week multicenter , r and omized , double-blind study of 380 subjects with IC who were treated with PPS 300 mg/day , 600 mg/day , or 900 mg/day .  Self-rated outcome measures included the O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) and a treatment satisfaction question naire . Treatment responders were defined as subjects having ≥30 % reduction in ICSI from baseline to study end point . Results : A reduction in IC symptoms was associated with significantly higher satisfaction with PPS ( p < 0.05 ) . Compared with nonresponders , subjects achieving a ≥30 % reduction in ICSI were more likely to be pleased with PPS for IC symptoms , to have benefited from PPS for their IC symptoms , to recommend PPS for IC symptoms to others with the same condition , and to say that PPS provides better relief , based on prior experience with other IC treatments . Among all subjects at week 32 , 75 % said they would recommend PPS therapy for IC symptoms to others with the condition . Conclusion : Despite limitations ( lack of placebo control , use of a nonvali date d instrument ) , this analysis demonstrated significantly increased treatment satisfaction with PPS therapy among treatment responders versus nonresponders . There was a significant positive correlation between ICSI scores and response on the treatment satisfaction question naire . Treatment response and patient satisfaction with treatment are important clinical considerations in the management of patients with IC PURPOSE Cyclosporine is a widely used immunosuppressive drug in organ transplantation and recently it has been used in several autoimmune disorders with good results . Because interstitial cystitis may have an autoimmune etiology , we wished to determine whether cyclosporine has any effect on symptoms in patients with severe interstitial cystitis . MATERIAL S AND METHODS A total of 11 patients , who fulfilled the criteria for interstitial cystitis according to an international accrual form , received cyclosporine for 3 to 6 months at an initial dose of 2.5 to 5 mg./kg . daily and a maintenance dose of 1.5 to 3 mg./kg . daily .  Blood pressure , serum creatinine and cyclosporine concentrations were monitored regularly . The patients completed frequency-volume charts at 2-week intervals . RESULTS The frequency-volume charts showed favorable effects . Micturition frequency decreased ( p<0.01 ) , and mean and maximum voided volumes increased significantly ( p<0.001 and p<0.01 , respectively ) . Bladder pain decreased or disappeared in 10 patients , allowing for storage of large urine volumes . Serum creatinine did not change with the dosages used . Mild hypertension occurred in 2 patients and resolved after the cyclosporine dose was lowered . After cessation of treatment symptoms recurred in the majority of patients . CONCLUSIONS The findings revive the concept of interstitial cystitis as an autoimmune disease INTRODUCTION AND AIM We report the 2-year efficacy and tolerability of intravesical botulinum A toxin ( BoNT/A ) injections in patients with painful bladder syndrome ( PBS ) associated with increased urinary frequency refractory to conventional treatments . MATERIAL S AND METHODS Thirteen women were prospect ively included in the study . The preliminary assessment included voiding diary , urodynamics , urinary tract ultrasound and the visual analog scale ( VAS ) for pain quantification . All patients received multiple injections of 200 U commercially available BoNT/A diluted in 20 ml 0.9 % NaCl , under cystoscopic guidance .  Clinical evaluation , urodynamics , urinary tract ultrasound and VAS were repeated at least two times per year throughout the follow-up . RESULTS A total of 58 injections were administered with a mean of 4.8 + /- 0.8 injections per patient . The mean interval between two consecutive injections was 5.25 + /- 0.75 months . At 1 and 4 mo follow up ten patients reported a subjective improvement . Mean VAS scores , mean daytime and night-time urinary frequency decreased significantly . Nine patients at 1 month and seven at the 4-month check-up complained of dysuria . The three non-responders to the first intravesical treatment session underwent another three months later with satisfactory results . At 1 and 2 years follow up the beneficial effects persisted in all patients . We did not observe any systemic side effects during the observation time . CONCLUSIONS Intravesically injected BoNT/A is effective and safe in the medium-term management of patients with PBS . As the beneficial effect decreased progressively within a few months after treatment , repeat injections of the neurotoxin were needed over time OBJECTIVES To present clinical evidence with botulinum toxin A ( BTX-A ) suggesting an antinociceptive role in patients with interstitial cystitis ( IC ) . Intriguing evidence in a somatic pain model has suggested that BTX-A injection may have an antinociceptive effect on both acute and chronic ( inflammatory ) pain . METHODS Thirteen female patients ( 6 in the United States and 7 in Pol and ) with IC according to the criteria of the National Institute of Diabetes , Digestive and Kidney Disease were included . Under short general anesthesia or sedation , 100 to 200 U of Dysport ( Polish patients ) or Botox ( U.S. patients ) was injected through a cystoscope into 20 to 30 sites submucosally in the trigone and floor of the bladder . Patients were evaluated with the O'Leary-Sant vali date d IC question naire or with voiding charts and a visual analog pain scale 1 month postoperatively and at subsequent 3-month intervals . The Polish patients also underwent pretreatment and post-treatment urodynamic evaluations . RESULTS Overall , 9 ( 69 % ) of 13 patients noted subjective improvement after BTX-A treatment . The Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index mean scores improved by 71 % and 69 % , respectively ( P < 0.05 ) . Daytime frequency , nocturia , and pain by visual analog scale decreased by 44 % , 45 % , and 79 % , respectively ( P < 0.01 ) . The first desire to void and maximal cystometric capacity increased by 58 % and 57 % , respectively ( P < 0.01 ) . CONCLUSIONS Our results suggest that BTX-A has an antinociceptive effect on bladder afferent pathways in patients with IC , producing both symptomatic and functional ( ie , urodynamic ) improvements PURPOSE This pilot study was design ed to evaluate the feasibility of a multicenter , r and omized , clinical trial in interstitial cystitis ( IC ) . Secondary objectives were to evaluate the safety and efficacy of oral pentosan polysulfate sodium ( PPS ) , hydroxyzine , and the combination to consider their use in a larger r and omized clinical trial . MATERIAL S AND METHODS A 2 x 2 factorial study design was used to evaluate PPS and hydroxyzine .  Participants met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC and reported at least moderate pain and frequency for a minimum of 6 months before study entry . The primary end point was a patient reported global response assessment . Secondary end points included vali date d symptom indexes and patient reports of pain , urgency and frequency . The target sample size was 136 participants recruited during 10 months . RESULTS A total of 121 ( 89 % of goal ) participants were r and omized over 18 months and 79 % provided complete followup data . The response rate for hydroxyzine was 31 % for those treated and 20 % for those not treated ( p = 0.26 ) . A nonsignificant trend was seen in the PPS treatment groups ( 34 % ) as compared to no PPS ( 18 % , p = 0.064 ) . There were no treatment differences for any of the secondary end points . Adverse events were mostly minor and similar to those in previous reports . CONCLUSIONS The low global response rates for PPS and hydroxyzine suggest that neither provided benefit for the majority of patients with IC . This trial demonstrated the feasibility of conducting a multicenter r and omized clinical trial in IC using uniform procedures and outcomes . However , slow recruitment underscored the difficulties of evaluating commonly available IC drugs Purpose Bladder pain syndrome is a chronic disease that manifests as bladder pain , frequency , nocturia , and urgency . Gabapentin , amitriptyline , and nonsteroidal anti-inflammatory drugs are efficacious treatments for bladder pain syndrome . Here , we assessed the effect of triple therapy with these drugs in women with bladder pain syndrome . Methods Between May 2007 and May 2010 , we conducted a prospect i ve nonr and omized study on 74 patients with bladder pain syndrome . Of these patients , 38 ( 11 men and 27 women ; mean age , 55.9 years ; range , 25 to 77 years ; mean follow-up , 12.6 months ) were administered the interstitial cystitis ( IC ) symptom scales ( O'Leary-Sant Symptom Index ) and visual analog scale ( VAS ) 1 , 3 , and 6 months after treatment to assess the efficacy of triple therapy . Results The pretreatment O'Leary-Sant IC symptom score was 11.7 , and the post-treatment scores were 4.4 , 3.8 , and 4.0 at 1 , 3 , and 6 months , respectively ; the pretreatment problem index score was 10.5 , and the post-treatment scores were 3.7 , 2.7 , and 2.9 at 1 , 3 , and 6 months , respectively . The pretreatment VAS score was 6.7 , and the post-treatment scores were 1.8 , 1.5 , and 1.7 at 1 , 3 , and 6 months , respectively . The O'Leary-Sant IC symptom index and problem index and VAS scores improved considerably 1 month after treatment ( P<0.05 ) . However , the results at 1 , 3 , and 6 months after treatment were not significantly different ( P>0.05 ) . Conclusions Triple therapy was sufficiently effective in patients with bladder pain syndrome and caused no significant adverse effects . However , large-scale studies should be performed to verify our findings PURPOSE In this r and omized , double-blind , placebo controlled phase 2 study we investigated tanezumab , a humanized monoclonal antibody that specifically inhibits nerve growth factor as a treatment for interstitial cystitis pain . MATERIAL S AND METHODS Patients with interstitial cystitis received a single intravenous dose of 200 μg/kg tanezumab or placebo . Patients recorded daily pain scores ( on an 11-point numerical rating scale ) 7 days before attending study visits and completed a urinary symptom diary for 3 of those days . Patients also completed the Interstitial Cystitis Symptom Index question naire and a global response assessment . The primary end point was change in average daily numerical rating scale pain score from baseline to week 6 . Secondary end points included global response assessment , Interstitial Cystitis Symptom Index score , micturition and urgency episode frequency per 24 hours , and mean voided volume per micturition . The incidence of adverse events was also assessed . RESULTS A total of 34 patients received tanezumab and 30 received placebo . At week 6 tanezumab produced a significant reduction from baseline in average daily pain score  vs placebo ( treatment difference [ LS mean , 90 % CI ] was -1.4 [ -2.2 , -0.5 ] ) . A significantly higher proportion of patients on tanezumab responded as improved in the global response assessment and tanezumab also significantly reduced urgency episode frequency  vs placebo . Tanezumab had no significant effect on Interstitial Cystitis Symptom Index score , micturition frequency or mean voided volume per micturition . The most common adverse events were headache  ( tanezumab 20.6 % , placebo 16.7 % ) and paresthesia  ( tanezumab 17.6 % , placebo 3.3 % ) . CONCLUSIONS Tanezumab has shown preliminary efficacy in the treatment of pain associated with interstitial cystitis PURPOSE Interstitial cystitis is a severe debilitating bladder disease characterized by unrelenting pelvic pain and urinary frequency . A prospect i ve , double-blind , placebo controlled study of the use of intravesical bacillus Calmette-Guerin ( BCG ) in the treatment of interstitial cystitis was recently completed with a mean followup of 8 months . Results demonstrated a 60 % BCG response rate , compared to a 27 % placebo response rate . We now report the long-term followup results of those patients who received intravesical BCG .  MATERIAL S AND METHODS Subjects r and omized to receive BCG  were followed at routine intervals with question naires and voiding diaries identical to those in the blinded study . Adverse events were closely monitored in the treatment and followup phases of the study . Subject baseline values were compared to followup data . RESULTS Of the BCG responders mean followup was 27 months ( range 24 to 33 ) , and 8 of 9 ( 89 % ) continue to have an excellent response in all parameters measured . The global interstitial cystitis survey improved 70 % , daily voids decreased 31 % , nocturia improved 54 % , mean voided volume increased 61 % , pelvic pain decreased 81 % , vaginal pain decreased 71 % , urgency decreased 71 % and dysuria decreased 82 % . Overall well-being improved 54 % and the R and -36 quality of life survey overall improved 64 % . In 86 % of the patients ( 6 of 7 ) dyspareunia resolved . Of the initial BCG nonresponders there was no significant difference in interstitial cystitis symptomatology from baseline to last followup , suggesting that BCG does not worsen interstitial cystitis symptoms . No long-term adverse events from BCG were noted . CONCLUSIONS Intravesical Tice BCG is safe , effective and durable in the treatment of interstitial cystitis . Of those patients who received only 6 weekly treatments and responded favorably 89 % continue to have an excellent response with followup ranging from 24 to 33 months A r and omized , prospect i ve , double-blind , placebo-controlled study was conducted at 7 clinical centers on 148 patients . Patients received orally either 100 mg . pentosanpolysulfate ( a synthetic polysaccharide ) 3 times per day or a placebo . Of the patients on drug therapy 32 % showed significant improvement compared to 16 % of those on placebo ( p = 0.01 ) . This study provides a model to assess this disease quantitatively in a prospect i ve manner using a method whereby the patients globally assess their symptoms as either worse or improved by 0 , 25 , 50 , 75 or 100 % . Patients on drug therapy also experienced a significant decrease in pain and urgency ( p = 0.04 and 0.01 ) on analogue scales when compared to placebo and also more drug patients showed an average increase of more than 20 ml . in voided volume than did placebo patients ( p = 0.02 ) . All adverse effects were minor , with 7 in the drug group and 10 in the placebo group . The results support the concept that some patients with the interstitial cystitis syndrome may have abnormal bladder surface glycosaminoglycans PURPOSE We examined the safety and the efficacy of a combination of intravesical and oral pentosan polysulfate sodium in comparison to only oral pentosan polysulfate sodium in treating interstitial cystitis . MATERIAL S AND METHODS A total of 41 females diagnosed with interstitial cystitis were r and omized to receive a combination of intravesical pentosan polysulfate sodium plus oral pentosan polysulfate sodium ( 21 in treatment group ) or intravesical placebo plus oral pentosan polysulfate sodium ( 20 in placebo group ) for 6 weeks . All subjects continued to receive oral pentosan polysulfate sodium for another 12 weeks . The primary outcome was the change in the O'Leary-Sant Interstitial Cystitis Symptoms/Problem Index from baseline to week 6 , 12 , and 18 . Other outcomes included : the changes in Pelvic Pain and Urgency Frequency question naire , Health Related Quality of Life index : SF-36 , pain scale , urgency scale , voiding log , patient global assessment , and sexual function scales . RESULTS The change in the total score of O'Leary-Sant Interstitial Cystitis Symptoms/Problems Index from baseline to week 12 among the treatment group ( median -12 or approximately a 46 % reduction ) was significantly greater compared to the placebo group ( median -5.5 or approximately a 24 % reduction , p = 0.04 ) . At week 18 the treatment group showed statistically significant improvement in all Health Related Quality of Life domains compared to the baseline ( p < or = 0.01 ) , while the placebo group showed significant improvement in only 3 Health Related Quality of Life domains , ( p < or = 0.05 ) compared to the baseline . There were no significant differences within major categories of adverse events between treated and placebo groups . CONCLUSIONS The use of intravesical pentosan polysulfate sodium simultaneously with oral pentosan polysulfate sodium is a safe and effective therapeutic option . These findings will open a new option for patients with interstitial cystitis to reduce their severely devastating symptoms and to improve their quality of life and well-being PURPOSE We have conducted a prospect i ve open-label study to examine the safety and efficacy of the long-term administration of the tricyclic antidepressant amitriptyline in patients with interstitial cystitis ( IC ) . METHODS Patients were stratified into 2 groups : an NIDDK group including patients fulfilling the NIDDK criteria for IC and a non-NIDDK group encompassing patients who presented the characteristic IC symptoms but met at least one of the NIDDK exclusion criteria .  Amitriptyline was taken strictly at bedtime following an established self-titration protocol without a limitation of the maximum daily dosage . Patients reporting improvement in a global response assessment question naire were defined as treatment responders . Further efficacy measures included changes of pain and urgency , functional bladder capacity and frequency . Changes in the O'Leary-Sant IC index and rating of overall satisfaction with the therapeutic outcome are reported as well . RESULTS The mean follow-up of the study was 19.0 + /- 12.5 months . The response rate was 64 % ( 60 patients ) . Overall mean dosage was 55 mg ( range : 12.5 - 150 mg ) . Side effects occurred in 79 patients ( 84 % ) ( dry mouth : 79 % , weight gain : 59 % ) . Patient overall satisfaction with the therapeutic result was either excellent or good in 43 patients ( 46 % ) . The drop-out rate was 31 % ( 29 patients ) after a mean treatment period of 6 weeks at a mean dosage of 70 mg . Non-response to treatment was the primary reason for drop-out in all cases , side effects contributed to drop-out in 25 patients ( 86 % ) . The various IC symptoms improved statistically significant compared with baseline . CONCLUSIONS Long-term administration of amitriptyline is a feasible , safe and effective treatment for IC provided that the drug is used judiciously to minimise adverse effects . The therapeutic response to amitriptyline was uniformly observed in patients fulfilling the NIDDK criteria and in those patients with the pure clinical diagnosis of IC Abstract Objective . Male chronic pelvic pain syndrome ( CPPS ) has been the subject of numerous clinical trials , but so far , no uniformly effective treatment has been identified . A commonly reported tender spot in men with CPPS is the bulbospongiosus muscle . A r and omized placebo controlled pilot trial of botulinum toxin A ( BTX-A ) injection into the perineal skeletal musculature for the treatment CPPS was conducted . Material and methods . Twenty-nine men with CPPS were identified from a urology clinic . Symptom evaluation was performed using a Global Response Assessment ( GRA ) and the Chronic Prostatitis Symptom Index ( CPSI ) .  All subjects were r and omized to receive either BTX-A 100 U or normal saline injected into the perineal body and bulbospongiosus muscle . Results . BTX-A  injection was administered in 13 men . At the 1 month follow-up there was a 30 % response rate for BTX-A treatment compared with 13 % for placebo ( p = 0.0002 ) , based on GRA results . Total CPSI score did not reach significance in the BTX-A-treated group , compared with controls . The CPSI pain subdomain score reached statistical significance in the BTX-A patients compared with controls ( p = 0.05 ) . The injections were well tolerated . There were no complications from the injections and no patients reported side-effects . Conclusions . BTX-A injection into the perineal body and bulbospongiosus muscle results in a modest response rate on the GRA compared with placebo for overall symptoms associated with CPPS . The treatment is well tolerated and safe . BTX-A use may enhance polytherapeutic pain management To assess the immediate and sustained relief of the symptoms of interstitial cystitis/painful bladder syndrome ( IC/PBlS ) after a consecutive 5‐day course of treatment with intravesical alkalinized lidocaine ( PSD597 ) , and to characterize the pharmacokinetics of single and multiple doses of intravesical PSD597 in a subgroup of patients PURPOSE We conducted a double-blind , sham controlled study to evaluate the safety , efficacy and feasibility of hyperbaric oxygenation for interstitial cystitis . MATERIAL S AND METHODS A total of 21 patients with interstitial cystitis were r and omized to 90 minutes treatment in a hyperbaric chamber pressurized with 100 % O2 to 2.4 atmosphere absolute for 30 treatments sessions or 1.3 atmosphere absolute , breathing normal air in the control group . Moderate or marked improvement in a global response assessment question naire was defined as treatment response ( primary outcomes ) . Secondary measurements included changes of pain and urgency evaluated by visual analog scales , functional bladder capacity and frequency . Changes in the O'Leary-Sant Interstitial Cystitis Index and rating of overall satisfaction with the therapeutic outcome were also reported . RESULTS There were 3 of 14 patients on verum and no control patients who were identified as responders ( p < 0.52 ) [ corrected ] At 12-month followup 3 patients ( 21.4 % ) still reported treatment response . Hyperbaric oxygenation result ed in a decrease of baseline urgency intensity from 60.2 + /- 15.0 to 49.9 + /- 35.2 mm at 3 months and decrease of pain intensity from 43.1 + /- 20.5 to 31.2 + /- 19.8 mm , respectively ( p < 0.05 ) . The Interstitial Cystitis Symptom Index score sum decreased from 25.7 to 19.9 points in patients on verum . Sham treatment did not result in improvement of the baseline parameters . CONCLUSIONS A total of 30 treatment sessions of hyperbaric oxygenation appear to be a safe , effective and feasible therapeutic approach to interstitial cystitis . In the treatment responders application of hyperbaric oxygenation result ed in a sustained decrease of interstitial cystitis symptoms with a discordant profile regarding the peak amelioration of the various interstitial cystitis symptoms compared with a normobaric , normoxic sham treatment Objective : To assess the efficacy of the oral prostagl and in analogue misoprostol in controlling the symptoms of  interstitial cystitis  in patients with refractory disease . Methods : Twenty-five patients were commenced on misoprostol 600 µg daily for 3 months . Patients who responded to therapy were offered treatment for a further 6 months . Assessment of the response was by a voiding log and an interstitial cystitis symptom score . Results : At 3 months , 14 patients ( 56 % ) had significantly improved , and after a further 6 months , 12 patients ( 48 % ) had a sustained response . The incidence of adverse drug effects was 64 % . Most side effects were minimal , and the response rate in patients who were able to tolerate the drug was 87 % at 3 months and 75 % at 9 months . Conclusions : The oral prostagl and in analogue misoprostol is effective in treating the symptoms of interstitial cystitis . It is possible that prostagl and ins have a cytoprotective action in the urinary bladder OBJECTIVE To evaluate the therapeutic efficacy of intravesical pentosanpolysulphate ( PPS ) compared with placebo in patients with interstitial cystitis ( IC ) . PATIENTS AND METHODS Twenty patients who fulfilled the diagnostic criteria for IC participated in a double-blind placebo-controlled study ; 10 received intravesical PPS ( 300 mg in 50 mL of 0.9 % sodium chloride ) applied twice a week for 3 months and the other 10 received a placebo .  Symptomatic relief and objective variables ( bladder capacity voiding volumes and urinary frequency ) were assessed after 3 months and the long-term outcome of those continuing treatment was determined . RESULTS Of the patients treated with PPS , four gained significant symptomatic relief compared with only two receiving placebo . Only the urodynamic bladder capacity showed a statistically significant increase in patients treated with PPS ( P = 0.047 ) . At 18 months from the start of the study , the symptoms were relieved in eight patients while still receiving PPS instillations and in four without treatment . CONCLUSIONS These results suggest that intravesical PPS is an effective option for the treatment of IC and shows that the intravesical application of PPS is a safe treatment with no important side-effects Pentosan polysulfate sodium ( PPS ) was compared with placebo for the symptomatic therapy of interstitial cystitis in a double-blind , multicenter study . A total of 110 patients were enrolled and treated for three months . In this study , overall improvement of greater than 25 percent was reported by 28 percent of the PPS-treated patients and by 13 percent of the placebo-treated patients ( p = 0.03 ) . The investigators ' overall evaluation provided similar results , 26 percent vs 11 percent in favor of PPS ( p = 0.04 ) . Improvement in pain and pressure to urinate also favored PPS over placebo and approached statistical significance ( p = 0.07 and 0.08 ) . The incidence of adverse reactions was 6 percent in the PPS-treated group and 13 percent in the placebo-treated group . All adverse reactions were minor , and treatment was discontinued by 1 patient in the PPS group and 2 in the placebo group . In this study , PPS was found to be significantly more effective than , and equally as safe as , placebo OBJECTIVES An oral preparation of pentosanpolysulfate sodium ( PPS ) was recently approved by the Food and Drug Administration for interstitial cystitis ( IC ) . Previously published articles have documented improvement in symptoms in 28 % to 63 % of patients , but no long-term studies have been published . No unique characteristics except for Hunner 's ulcer have been found in patients experiencing relief from PPS . We report our experience with PPS  following patients up to 116 months and analyze baseline parameters in an attempt to characterize long-term responders . METHODS Baseline and follow-up data from 97 patients with IC and enrolled in a compassionate use study with PPS at the University of Wisconsin from 1987 to 1995 are analyzed . Previous treatments had failed , and patients had to pay for PPS . Patients continuing treatment with PPS were monitored every 3 months with question naires and laboratory tests . In 1996 an up date on medication and a question naire developed by the National Institutes of Health Interstitial Cystitis Data base were sent to patients who had discontinued treatment . RESULTS By the end of the study period 11 ( 11.3 % ) of the patients were still taking PPS , with 6 ( 6.2 % ) doing so continuously for more than 18 months . Three ( 3 % ) patients who discontinued PPS were in long-term remission . An additional 15 % had remission for a substantial period . Except for a weak correlation between less constant pain ( P = 0.0439 ) , no correlations were found between baseline parameters and duration of treatment with PPS . CONCLUSIONS On a long-term basis , between 6.2 % and 18.7 % of patients with IC benefit from PPS . The only baseline factor predicting response to PPS was less constant pain OBJECTIVES To determine the usefulness of oral hydroxyzine for the treatment of  symptomatic interstitial cystitis .  METHODS This study was an open-label , nonconsecutive case series of patients treated by their local physicians , in consultation with the authors . A case-report form using visual analog scales was used to assess outcomes . RESULTS Out of 140 patients , 90 ( 65 % ) returned the case-report forms . A 40 % reduction in symptom scores was reported . This rose to 55 % in patients with a history of allergies . CONCLUSIONS Hydroxyzine is a useful drug for the symptomatic treatment of IC , especially in patients with documented allergies and /or evidence of bladder mast cell activation Background : Current medications used in the treatment of interstitial cystitis ( IC ) have limited efficacy . This prospect i ve study investigated the efficacy of multiple intravesical instillations of resiniferatoxin ( RTX ) at the concentration of 10 nM. Methods : Patients with proven IC previously treated with traditional medications for more than 6 months without clinical benefit were enrolled . They were excluded if bladder outlet obstruction or urinary tract infection was present .  Intravesical instillation of low-dose RTX ( 10 nM ) once weekly for 4 weeks was performed at the outpatient department . International Prostate Symptom Score ( IPSS ) , 5-Point Pain Scale , and Quality of Life Index ( QOL Index ) were recorded . A videourodynamic study was done at baseline and 3 months after treatment . Results : The therapeutic results and urodynamic parameters were compared between baseline and 3 months . Thirteen patients , including 10 women and 3 men , were enrolled in this study . The mean duration of IC  symptoms was 4.4 ± 2.5 years . The mean duration of active treatment was 15.3 ± 8.6 months . One female patient dropped out due to severe bladder pain after RTX instillation . Among the 12 patients who completed the study treatment , subjective assessment revealed that 2 had an excellent therapeutic result , 5 had an improved result and 5 remained unchanged from baseline . The overall satisfactory rate was 58.3 % . IPSS , 5-Point Pain Scale , and QOL Index were significantly decreased after RTX treatment . There was no significant increase in mean functional bladder capacity or change in urodynamic parameters . No serious adverse event occurred after RTX treatment . Conclusions : This study suggests that multiple intravesical instillations of RTX at the concentration of 10 nM are effective in relieving lower urinary tract symptoms in patients with refractory IC . The treatment is tolerable and suitable for use on an outpatient clinic basis PURPOSE Present therapeutic approaches to control hypersensitive disorder of the lower urinary tract and bladder pain are clinical ly and scientifically unsatisfactory . We performed a r and omized placebo controlled study with followup after 1 and 3 months using intravesical resiniferatoxin to treat hypersensitive disorder and bladder pain . MATERIAL S AND METHODS We prospect ively r and omized 18 patients into 2 groups to receive a single dose of 10 nM. resiniferatoxin intravesically ( group 1 ) or a placebo saline solution only ( group 2 ) . All patients had at least a 6-month history of frequency , nocturia , urgency and symptoms of pelvic pain as well as no urinary tract infection within the last 3 months , functional disorders of the lower urinary tract , or other vesical or urethral pathology . Pretreatment voiding pattern and pain score were recorded . Patients were evaluated after 30 days ( primary end point ) and 3 months ( secondary end point ) . RESULTS The 2 groups were adequately homogeneous in regard to patient age , sex ratio , disease duration , voiding pattern and pain score . At the primary end point mean frequency plus or minus st and ard error of mean was decreased from 12 . 444 + /- 0.70 voids to 7.111 + /- 0.67 and nocturia from 3.777 + /- 0 . 27 to 1.666 + /- 0.16 ( p < 0.01 ) . We observed a lesser significant improvement in mean frequency in group 1 at the secondary end point to 10.444 + /- 0.94 voids ( p < 0.05 ) . No significant modification was noted in patients assigned to placebo .  Mean pain score significantly decreased in group 1 at the primary end point from 5.555 + /- 0.29 to 2.666 + /- 0.23 ( p < 0.01 ) but not at the secondary end point ( 4.777 + /- 0.66 , p > 0.05 ) . No statistically significant improvement in mean pain score was observed in placebo group 2 . During resiniferatoxin infusion 4 group 1 patients noticed a light warm or burning sensation at the suprapubic and /or urethral level . CONCLUSIONS Intravesical resiniferatoxin may significantly improve the voiding pattern and pain score in patients with hypersensitive disorder and bladder pain . Because resiniferatoxin did not cause a significant warm or burning sensation at the suprapubic and /or urethral level , it may be considered a new strategy for treating hypersensitive disorder and bladder pain . However , further studies are necessary to confirm our results and define the resiniferatoxin mechanism of action , dose and necessary treatment schedule Objectives To determine , in a double‐blind placebo‐controlled crossover study , whether l‐arginine improves the symptoms of interstitial cystitis ( IC ) , a chronic condition in which nitric oxide ( NO ) may be important , as previous open pilot studies suggested that l‐arginine reduced the pain and frequency associated with IC PURPOSE We evaluated the effectiveness of combining behavioral therapy , pharmacologic therapy and endoscopic hydrodistension for treating  painful bladder syndrome / interstitial cystitis ( PBS/IC ) .  MATERIAL S AND METHODS Twenty-five patients with PBS/IC were prospect ively enrolled in a pilot multimodal behavioral , pharmacologic and endoscopic treatment protocol . Behavioral modification included diet recommendations , fluid restriction to 64 oz . /day , progressive timed voiding and Kegel exercises . Oral pharmacologic therapy consisted of daily doses of macrodantin 100 mg , hydroxyzine 10 - 20 mg and urised 4 tablets .  Patients underwent endoscopic bladder hydrodistention under anesthesia  at least 2 weeks after protocol enrollment . Behavioral and pharmacological treatments were continued after the hydrodistention . O'Leary-Sant question naire scores were recorded before starting the protocol , after pharmacologic/behavioral therapy , 2 months post-hydrodistension , and at scheduled follow-up . RESULTS Eighteen patients ( 72 % ) completed the pilot multimodal treatment protocol and were followed for a mean of 10.2 months . All patients were female with a median age of 36.3 years and had mean bladder capacity under anesthesia of 836 milliliters .  Mean O'Leary-Sant symptom index scores for baseline symptoms , after behavioral/pharmacologic treatment , post-hydrodistension and during follow up were 12.5 , 8.6 , 7.0 , and 6.7 ( p < 0.05 ) . Mean O'Leary-Sant problem index scores for baseline , after behavioral/pharmacologic treatment , post-hydrodistention and during follow up were 12.7 , 8.9 , 6.7 , and 7.7 ( p < 0.05 ) . CONCLUSION Our pilot multimodal protocol of behavioral modification , pharmacologic therapy and endoscopic hydrodistention demonstrated a significant progressive improvement in PBS/IC quality of life scores , compared to a pre-treatment baseline . These results should be vali date d in a larger , placebo controlled trial PURPOSE We compared intravesical bacillus Calmette-Guerin ( BCG ) to placebo instillations in patients with treatment refractory interstitial cystitis ( IC ) . MATERIAL S AND METHODS Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC , and reported at least moderate pain and frequency for a minimum of 6 months before study entry , were r and omized to 6 weekly double-blinded intravesical instillations of either BCG or placebo , and then followed for a total of 34 weeks . The primary outcome was a patient reported global response assessment at week 34 , supplemented with medications for IC during weeks 31 to 34 . Secondary outcomes included a 24-hour voiding diary , pain , urgency , vali date d IC symptom indexes and adverse events . The target sample size was 260 participants , design ed to detect a difference in response rates between placebo and BCG of 30 % and 50 % , respectively . RESULTS A total of 265 participants were r and omized and 17 ( 6 % ) patients withdrew from study . The response rates for the primary outcome were 12 % for placebo and 21 % for BCG ( p = 0.062 ) . Small improvements were observed for all secondary outcomes , some more so with BCG , but these differences were of borderline statistical significance . Although a large number of adverse events were reported in the BCG arm , there was no statistically significant difference between the treatment arms in overall adverse event rates . CONCLUSIONS Although the BCG safety profile was acceptable , the response rate for the primary outcome was low . Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive OBJECTIVES To evaluate the effectiveness of transvaginal manual therapy of the pelvic floor musculature ( Thiele massage ) in symptomatic female patients with interstitial cystitis and high-tone dysfunction of the pelvic floor . METHODS A total of 21 women with documented interstitial cystitis and high-tone pelvic floor dysfunction underwent transvaginal massage using the Thiele technique twice a week for 5 weeks . Symptoms were evaluated before massage , at protocol conclusion , and at a mean of 4.5 months after therapy completion ( long-term follow-up ) . The response to treatment was evaluated through the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes , Likert Visual Analogue Scales for urgency and pain , and Short-Form 12-item ( SF-12 ) Quality -of-Life Scale , and through changes in the physical examination findings using a 5-point modified Oxford Scale to document pelvic floor tenderness . RESULTS A statistically significant improvement was seen in the Symptom and Problem Indexes of the O'Leary-Sant Question naire ( P = 0.015 and P = 0.039 , respectively ) , Likert Visual Analogue Scales for urgency and pain ( P = 0.001 and P = 0.005 , respectively ) , the Physical and Mental Component Summary from the SF-12 Quality -of-Life Scale ( P = 0.049 and P = 0.044 , respectively ) , and the modified Oxford Scale ( P < 0.05 ) after protocol completion . At long-term follow-up , the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes ( P = 0.049 and P = 0.02 , respectively ) , Likert Visual Analogue Scales for urgency and pain ( P = 0.004 and P = 0.005 , respectively ) , and modified Oxford Scale for three of four muscles in the pelvic floor ( P < 0.05 ) remained significantly improved . CONCLUSIONS Thiele massage appears to be very helpful in improving irritative bladder symptoms in patients with interstitial cystitis and high-tone pelvic floor dysfunction in addition to decreasing pelvic floor muscle tone OBJECTIVES To test the efficacy of a new intravesical therapeutic solution in relieving urgency/frequency and pain in interstitial cystitis ( IC ) . METHODS A solution of 40,000 U heparin , 8 mL 1 % lidocaine ( 80 mg ; group 1 ) or 2 % lidocaine ( 160 mg ; group 2 ) , and 3 mL 8.4 % sodium bicarbonate was administered intravesically in patients with newly diagnosed IC with significant frequency , urgency , and pain . Using the Patient Overall Rating of Improvement of Symptoms , the response to treatment was evaluated within 20 minutes of instillation in all patients , after 24 to 48 hours in group 2 , and after three treatments per week for 2 weeks in group 2 patients who elected to receive additional instillations . Significant symptom relief was defined as 50 % or greater symptom improvement . RESULTS After one instillation , 35 ( 75 % ) of 47 patients in group 1 ( 1 % lidocaine ) and 33 ( 94 % ) of 35 in group 2 ( 2 % lidocaine ) reported significant immediate symptom relief . The difference in the response rates was statistically significant ( P < 0.01 ) . In group 2 , 50 % of the subjects experienced at least 4 hours of symptom relief from the single instillation , and 16 ( 80 % ) of 20 reported significant sustained symptom relief after 2 weeks of treatment . CONCLUSIONS Intravesical treatment with combined heparin and alkalinized lidocaine immediately reduced the pain and urgency of IC in most patients treated for newly diagnosed IC . Symptom relief lasted beyond the duration of the local anesthetic activity of lidocaine , suggesting the solution suppresses neurologic upregulation . In IC treatment , this new intravesical solution may be helpful in the interval before heparinoid therapy reaches its full effect OBJECTIVES To compare the current recommended dose of pentosan polysulfate sodium ( PPS ) with doses two to three times higher . METHODS We evaluated three dosages ( 300 , 600 , and 900 mg ) of PPS in a r and omized , double-blind , double-dummy , parallel-group , multicenter , 32-week study . Adults ( n = 380 ) with a diagnosis of interstitial cystitis ( IC ) as determined by a positive cystoscopic examination combined with bladder pain and urgency or a history of IC symptoms for at least 6 months were enrolled . Participants completed the Patient 's Overall Rating of Symptom Index ( PORIS ) and the O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) at baseline ( ICSI only ) and during follow-up visits at 4 , 8 , 12 , 16 , 24 , and 32 weeks . RESULTS Mean ICSI scores improved significantly during the 32 weeks for all dosages ( baseline 11.2 , 11.9 , and 11.9 to endpoint 8.2 , 8.1 , 8.6 for 300 , 600 , and 900 mg , respectively ; P < 0.001 ) but the response to treatment was not dose dependent ( no statistically significant difference in response among the three dosages ) . At baseline , 3.2 % , 62.2 % , and 34.6 % reported mild , moderate , and severe symptoms , respectively , as assessed by the ICSI . At study end , 27.5 % , 56.9 % , and 15.7 % reported mild , moderate , and severe symptoms , respectively . The PORIS scores improved within 4 weeks with 15.8 % to 21.1 % of all patients classified as responders ( 50 % or greater improvement on PORIS ) . At 32 weeks , 49.6 % , 49.6 % , and 45.2 % of all patients were responders at a dose of 300 , 600 , and 900 mg , respectively . Most adverse events were mild and resolved without intervention . CONCLUSIONS For all three dosages of PPS , a clinical ly significant but similar response was demonstrated . The duration of therapy appears to be more important than the dosage OBJECTIVES The long-term efficacy and safety of Elmiron ( oral pentosan polysulfate sodium ) in relieving recurring symptoms of interstitial cystitis ( IC ) were investigated in a long-term , open-label physician 's usage study . METHODS Patients with diagnosed interstitial cystitis who met the study entry criteria received shipments of Elmiron  for 3 months at a dose of 100 mg 3 times a day and for the consecutive 3-month periods , provided they completed and returned question naires about their disease symptoms , reported any adverse events , and had laboratory data collected before each new shipment . Patients were required to purchase the medication . Responses to question naires provided the data reported here . Several symptomatic parameters of the disease ( overall improvement , overall improvement in pain and urgency , urinary frequency , and nocturia ) were recorded in this way and used to evaluate efficacy . RESULTS Elmiron usage was correlated with improvements in some symptoms , and these improvements increased with duration of treatment . Some symptoms were improved within 5 months , although most continued to show improvements in both severity rating and in percentage of positive responders over 1 to 2 years . Population s of patients receiving extended treatment , some for > 90 months , showed no further improvement or worsening in symptom values . Forty-six percent of patients dropped out of the study within the first 3 months of Elmiron treatment . The frequency of adverse events was < 4 % . The most notable adverse events were reversible alopecia , diarrhea , nausea , headache , and rash . CONCLUSIONS Elmiron appears to be an efficacious long-term treatment for reducing a constellation of debilitating symptoms associated with interstitial cystitis in some patients . Patients with a positive response to Elmiron appear to maintain this response over time Nifedipine is a calcium channel antagonist known to inhibit smooth muscle contraction and cell-mediated immunity . The clinical and local immune response to nifedipine was investigated in an open trial with 10 female interstitial cystitis patients , whose disease was diagnosed according to the consensus criteria developed in 1987 at a National Institutes of Health workshop . To evaluate the symptoms and clinical response of the patients objective ly we scored the symptoms of frequency , urgency , nocturia , dysuria and suprapubic pain on a scale of 0 to 2 . Nifedipine was administered as a single daily dose determined by a dose-titration test . Urinary interleukin-2 inhibitor activity , a marker of cell-mediated inflammation , was measured using a murine interleukin-2 dependent cell line . Before nifedipine therapy the symptom scores ( total of the 5 symptoms ) ranged between 5 and 9 , and after 2 months they ranged between 0 and 6 . Of the 9 patients followed for at least 4 months only 1 failed to have a significant clinical improvement , 5 showed at least a 50 % decrease in symptom scores and 3 were asymptomatic . Drug side effects were minimal . Urinary interleukin-2 inhibitor activity before nifedipine therapy confirmed the presence of cell-mediated inflammation . After 4 months of therapy interleukin-2 inhibitor activity was normal in 7 of 9 patients regardless of the severity of symptoms , which indicated that nifedipine exerted an immunosuppressive effect . Although our data suggest that nifedipine is an efficacious , well tolerated , convenient oral medication for the treatment of interstitial cystitis , the true value of nifedipine for patients with this disease must be determined by a prospect i ve , r and omized trial of nifedipine versus placebo To report a multicentre , community based open‐label study design ed to assess the efficacy and safety of intravesical sodium chondroitin sulphate in the treatment of patients with the clinical diagnosis of interstitial cystitis ( IC ) .  Chondroitin sulphate is a naturally occurring glycosaminoglycan ( GAG ) in the bladder mucus layer and changes in this GAG have been implicated in the pathogenesis of IC , and small single‐centre studies have suggested that intravesical chondroitin sulphate may have efficacy in IC PURPOSE Interstitial cystitis is a debilitating bladder disease of unknown etiology with no cure . A recent report suggested that bacillus Calmette-Guerin ( BCG ) may be effective in the treatment of interstitial cystitis . A r and omized , prospect i ve , double-blind , placebo controlled trial to evaluate the safety and efficacy of intravesical BCG in treating interstitial cystitis was done . MATERIAL S AND METHODS Patients meeting the National Institute of Arthritis , Diabetes and Digestive and Kidney Diseases criteria for interstitial cystitis received 6 weekly instillations of Tice strain BCG or placebo .  Periodic question naires , voiding diaries and cystometrograms were obtained . A total of 30 evaluable subjects was enrolled in the study with a mean followup of 8 months ( range 6 to 13 ) . Based on an exit question naire a responder was defined as one who rated the interstitial cystitis symptoms as moderately improved or better . RESULTS A 60 % BCG response rate was noted , compared to a 27 % placebo response rate . Minimum voided volume and quality of life improved in the BCG group compared to placebo .  Adverse events were similar in each group , mostly irritative in nature , and no significant systemic events were noted . CONCLUSIONS Intravesical Tice strain BCG appears to be safe and efficacious in the treatment of interstitial cystitis . Additional studies must be performed to confirm the results of this pilot study PURPOSE We evaluated the longer term response in patients with interstitial cystitis who initially responded to intravesical bacillus Calmette-Guerin or placebo  in a r and omized clinical trial . MATERIAL S AND METHODS Patients with interstitial cystitis who responded positively to treatment with bacillus Calmette-Guerin or placebo after 34 weeks of followup in a double-blind clinical trial were followed for an additional 34 weeks in an observational study to assess response durability . Outcomes at 68 weeks included a patient reported global response assessment , 24-hour voiding diary , and pain , urgency and vali date d interstitial cystitis symptom indexes . RESULTS Of responders to bacillus Calmette-Guerin or placebo in the clinical trial 38 continued extended followup in the observational study . A total of 12 ( 75 % ) responders who received placebo and 19 ( 86 % ) who received bacillus Calmette-Guerin considered themselves to remain moderately or markedly improved at week 68 . Improved symptom outcomes were also generally maintained during followup in the 2 groups . CONCLUSIONS Most patients who respond to therapy with intravesical bacillus Calmette-Guerin or placebo maintain improved symptoms for up to 68 weeks after the initiation of therapy . However , initial response rates are low and placebo responders demonstrated essentially the same durability of response as bacillus Calmette-Guerin responders . These results argue against the routine use of bacillus Calmette-Guerin in this patient group Objective . Interstitial cystitis is a condition with a poorly understood etiology and , consequently , various treatment options have been described in the literature , with a less than optimal outcome . The aim of this study was to examine the role of a combination of intravesical hydrocortisone and heparin , together with oral bladder sedatives and systemic triamcinolone , for the treatment of interstitial cystitis . Material and methods . A total of 26 patients who were diagnosed as having interstitial cystitis were treated with weekly intravesical hydrocortisone ( 200 mg ) and heparin ( 25 000 IU ) in physiological saline for 6 weeks . In addition , they were given oral bladder sedatives such as oxybutynin or tolterodine . Ulcerative , refractory and recurrent cases were treated with intramuscular triamcinolone ( 40 mg ) weekly for 6 weeks . Results . All patients experienced an improvement in symptoms within 48 h of their first intravesical instillation . While 19 patients ( 73 % ) experienced almost complete pain relief , five of the remaining seven patients improved with intramuscular triamcinolone .  Frequency reduced from a mean of 23.2 to 10.9 voids per day and was acceptable in 21 patients ( 80 % ) . Six patients ( 23 % ) had a relapse of symptoms in the form of pain and were treated satisfactorily by means of intramuscular triamcinolone . The mean duration of follow-up was 18.3 months . Conclusion . A combination of intravesical hydrocortisone and heparin , along with oral bladder sedatives and systemic steroids , has been used with encouraging results in a small group of patients with interstitial cystitis INTRODUCTION The aim of this study was to examine the efficacy and safety of intravesical Bacillus Calmette-Guerin ( BCG ) in the treatment of refractory interstitial cystitis ( IC ) . MATERIAL S AND METHODS Thirteen patients with refractory IC were enrolled in the study . They were scheduled to receive 6 weekly courses of treatment with intravesical BCG . Variables including the frequency , nocturia , urgency , pelvic pain , dyspareunia , dysuria , IC symptom index , IC problem index , and average voided volume were assessed every 6 months after the BCG therapy . RESULTS Thirteen patients received the complete course of intravesical BCG therapy . Twenty-four months after the treatment a mean improvement of 51.9 % was seen in frequency ( P=.001 ) , 43.2 % in nocturia ( P=.002 ) , 28.7 % in urgency ( P=.004 ) , 43.1 % in pelvic pain ( P=.001 ) , 58.3 % in dyspareunia ( P=.003 ) , 6.5 % in dysuria ( P=.16 ) , 57.7 % in the O'Leary-Sant IC symptom index ( P=.001 ) , and 61.8 % in the O'Leary-Sant IC problem index ( P=.001 ) scores . A significant improvement was seen in the mean average voided volume at the 24th follow-up month ( 89.5 % ; P=.001 ) . CONCLUSION Intravesical BCG is a relatively effective treatment in patients with refractory IC . Its efficacy seems to be modest and lasts for at least 24 months in majority of the patients . It is also safe and well tolerated PURPOSE Interstitial cystitis is a disorder of the bladder characterized by urgency and frequency of urination , and pelvic pain . The classic type of interstitial cystitis is characterized by Hunner 's ulcers , which are focal regions of severe bladder inflammation . Patients with Hunner 's ulcers tend to have more severe symptoms and are often refractory to medical management . We present a prospect i ve series of patients who underwent ablative therapy of Hunner 's ulcers using a neodymium (Nd):YAG laser . MATERIAL S AND METHODS A total of 24 patients with interstitial cystitis underwent ablative therapy for Hunner 's ulcers . Medical therapy had failed in all cases . Using regional or general anesthesia the Nd : YAG laser under cystoscopic control was used to ablate the ulcers . The power setting was 15 W. with a firing duration of between 1 and 3 seconds . The procedure was performed on an outpatient basis . Symptoms were noted preoperatively and postoperatively . RESULTS All patients had symptom improvement within 2 to 3 days . The mean pain scores decreased from 9.1 to 1.2 ( p < 0.003 ) , the mean urgency score decreased from 8.2 to 1.9 ( p < 0.003 ) , the mean voiding interval increased from every 30 minutes to every 102 ( p < 0.0001 ) and nocturia decreased from a mean of 7.9 voids per night to 2.9 ( p < 0.0001 ) . There were no complications . Mean followup was 23 months . However , relapse in 11 patients required 1 to 4 additional treatments . The re-treatment response was similar to the initial treatment . CONCLUSIONS Nd : YAG laser ablation of Hunner 's ulcers is an excellent , minimally invasive method of treating interstitial cystitis . While it is not a cure , it offers patients an opportunity to have decreased symptoms for an extended period and it may be repeated as necessary PURPOSE Amitriptyline is frequently used to treat patients with interstitial cystitis/painful bladder syndrome . The evidence to support this practice is derived mainly from a small , single site clinical trial and case reports . MATERIAL S AND METHODS We conducted a multicenter , r and omized , double-blind , placebo controlled clinical trial of amitriptyline in subjects with interstitial cystitis/painful bladder syndrome who were naïve to therapy . Study participants in both treatment arms received a st and ardized education and behavioral modification program . The drug dose was increased during a 6-week period from 10 up to 75 mg once daily . The primary outcome was a patient reported global response assessment of symptom improvement evaluated after 12 weeks of treatment . RESULTS A total of 271 subjects were r and omized and 231 ( 85 % ) provided a global response assessment  at 12 weeks of followup . Study participants were primarily women ( 83 % ) and white ( 74 % ) , with a median age of 38 years . In an intent to treat analysis ( 271 ) the rate of response of subjects reporting moderate or marked improvement from baseline in the amitriptyline and placebo groups was 55 % and 45 % , respectively ( p = 0.12 ) . Of the subgroup of subjects ( 207 ) who achieved a drug dose of at least 50 mg , a significantly higher response rate was observed in the amitriptyline group ( 66 % ) compared to placebo ( 47 % ) ( p = 0.01 ) . CONCLUSIONS When all r and omized subjects were considered , amitriptyline plus an education and behavioral modification program did not significantly improve symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome . However , amitriptyline may be beneficial in persons who can achieve a daily dose of 50 mg or greater , although this subgroup comparison was not specified in advance PURPOSE We conducted a prospect i ve , double-blind study with a crossover design of intravesical bacillus Calmette-Guerin ( BCG ) and dimethyl sulfoxide to determine whether patients with classic and nonulcer interstitial cystitis , respectively , might benefit from either regimen . MATERIAL S AND METHODS A total of 21 patients , including 11 with classic and 10 with nonulcer interstitial cystitis , r and omly underwent treatments with intravesical BCG or dimethyl sulfoxide and , if not improved , were treated with the other substance after a washout period . All 21 patients were evaluated with symptom question naires , including a visual analog pain scale and voiding diaries . RESULTS Regardless of regimen , there was no improvement in maximal functional capacity . There was a reduction in urinary frequency following dimethyl sulfoxide treatment but only in the classic subtype ( p < 0.05 ) , whereas no reduction was seen following BCG in either subtype . A substantial pain decrease was noted in classic ( p < 0.05 ) as well as nonulcer ( p < 0.05 ) interstitial cystitis following dimethyl sulfoxide . CONCLUSIONS Intravesical BCG has been presented as a promising new option for treatment of interstitial cystitis . We failed to demonstrate benefit from this treatment . Dimethyl sulfoxide had no positive effect on maximal functional capacity but result ed in a significant reduction in pain and urinary frequency , although only in patients with classic interstitial cystitis OBJECTIVES To evaluate the efficacy of intravesical instillation of hyaluronic acid ( HA ) after hydrodistention for the treatment of patients with interstitial cystitis ( IC ) having small bladder capacity . METHODS A total of 47 patients with IC ( aged 27 - 76 years ) whose functional bladder capacity was less than 200 mL received bladder hydrodistention .  Thereafter , 20 patients received intravesical instillation of 40 mg HA weekly in the first month and then monthly in the following 2 months . Sixteen patients received intravesical heparin instead and 11 patients received hydrodistention alone as the control . Mean voids per day , visual analog scale for pain , and functional bladder capacity were measured before hydrodistention and 3 and 6 months after hydrodistention in all 3 groups and 9 months after hydrodistention in HA and heparin groups . RESULTS Two patients in the HA group and 1 in the heparin group failed to complete the treatment . Three months after hydrodistention , there was no improvement in the control group . Six and 9 months after hydrodistention , rate of improvement was significantly higher in the HA group than in the heparin group ( 77.8 % vs 33.3 % , P < .05 ; 50 % vs 20 % , P < .05 ) . At 9 months , heparin treatment did not show any improvement . Improvement in voids per day ( -1.8 + /- 2.5 , P < .01 ) , visual analog scale ( -0.9 + /- 1.1 , P < .01 ) , and bladder capacity ( 16 + /- 18 mL , P < .01 ) was still significant in the HA group . CONCLUSIONS Intravesical instillation of HA may obviously prolong the effect of bladder hydrodistention in patients with severe IC . Its effect was better than heparin PURPOSE Urinary nitric oxide synthase activity is decreased in patients with interstitial cystitis . Since nitric oxide may be an important determinant of the symptoms and immunological responses associated with interstitial cystitis , patients with this disease were treated with oral L-arginine , the substrate for nitric oxide synthase . MATERIAL S AND METHODS Ten patients took 1.5 gm . L-arginine orally daily for 6 months . Interstitial cystitis symptoms were surveyed before and during the 6-month trial . RESULTS Oral L-arginine treatment result ed in a significant decrease in urinary voiding discomfort , lower abdominal pain and vaginal/urethral pain . Urinary frequency during the day and night also significantly decreased . CONCLUSIONS This self-controlled study provides evidence that long-term oral L-arginine improves interstitial cystitis related symptoms PURPOSE Interstitial cystitis is a chronic disease of unknown etiology characterized by bladder pain , urgency and frequency . Although a single microbe has not been implicated as a cause of interstitial cystitis , several groups noted various organisms in the urine of some women with interstitial cystitis and some patients reported that antibiotics decrease symptoms . Consequently we performed a prospect i ve , r and omized , double-blinded , placebo controlled pilot study of sequential oral antibiotics . MATERIAL S AND METHODS We r and omized 50 patients with interstitial cystitis to receive 18 weeks of placebo or antibiotics , including rifampin plus a sequence of doxycycline , erythromycin , metronidazole , clindamycin , amoxicillin and ciprofloxacin for 3 weeks each . RESULTS Intent to treat analysis demonstrated that 12 of 25 patients ( 48 % ) in the antibiotic and 6 of 25 ( 24 % ) in the placebo group reported overall improvement ( p = 0.14 ) , while 10 and 5 , respectively , noticed improvement in pain and urgency ( p = 0.22 ) . In the antibiotic group 20 participants ( 80 % ) had adverse effects compared with 10 ( 40 % ) in the placebo group ( p = 0.009 ) . CONCLUSIONS Our findings suggest that these antibiotics alone or in combination may sometimes be associated with decreased symptoms in some patients but they do not represent a major advance in therapy for interstitial cystitis INTRODUCTION To assess the impact of intravesically injected botulinum A toxin ( BoNT/A ) upon bladder pain , urological complaints , symptoms of anxiety and depression , and Quality of Life ( QoL ) in patients with painful bladder symptoms ( PBS ) refractory to conventional treatment . PATIENTS AND METHODS In this prospect i ve study 14 patients received one injection of BoNT/A ( 200 U diluted in 20 ml 0.9 % NaCl ) , under cystoscopic guidance . At pre- and 3 months post- treatment all patients underwent an urological assessment ( voiding diary , urodynamics ) , a pain quantification on a visual analog scale ( VAS ) , an evaluation with the 14-item Hamilton Anxiety Rating Scale ( HAM-A ) to assess symptoms of psychic and somatic anxiety , an evaluation with the Hamilton Depression Rating Scale ( HAM-D ) to assess depression , and the 36-item Medical Outcomes Study Short Form ( SF-36 ) to assess QoL. Results . At pre-treatment all 14 patients had increased daytime and nighttime urinary frequency and high VAS scores . Nine patients had pathological HAM-A scores and all had pathological HAM-D scores . At the 3-month follow-up 10/14 patients reported a subjective improvement in pain . Mean VAS score , mean daytime and nighttime urinary frequency decreased significantly ( p < 0.01 , < 0.01 and < 0.01 , respectively ) . All domains in SF-36 and HAM-A significantly improved ( p<0.01 ) . All domains , except weight and sleep disorders , significantly improved in HAM-D , particularly somatoform symptoms ( p<0.01 ) , cognitive performance ( p<0.01 ) , and circadian variations ( p<0.01 ) . CONCLUSION In patients with refractory PBS with symptoms of anxiety , depression and poor QoL , BoNT/A intravesical treatment reduced bladder pain , improved psychological functioning , and well-being PURPOSE The efficacy of sacral neuromodulation for the treatment of symptoms in patients with refractory interstitial cystitis was evaluated . MATERIAL S AND METHODS A total of 25 patients with a mean age of 47 years and refractory interstitial cystitis were prospect ively evaluated with a trial of sacral nerve stimulation .  Patients who demonstrated 50 % improvement in frequency , nocturia , voided volume and average pain qualified for permanent sacral nerve stimulator implantation .  Treatment success was measured by voiding diary , report of average pain , and response to the Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index . RESULTS Of the 25 patients 17 qualified for permanent sacral nerve stimulator implantation .  At an average of 14 months followup mean daytime frequency and nocturia improved from 17.1 to 8.7 and 4.5 to 1.1 , respectively ( p < 0.01 ) . Mean voided volume increased from 111 to 264 ml . ( p < 0.01 ) . Report of average pain decreased from 5.8 to 1.6 points on a scale of 0 to 10 ( p < 0.01 ) . Interstitial Cystitis Symptom and Problem Index scores decreased from 16.5 to 6.8 and 14.5 to 5.4 , respectively ( p < 0.01 ) . Of the 17 patients 16 ( 94 % ) with a permanent stimulator demonstrated sustained improvement in all parameters at the last postoperative visit . CONCLUSIONS Results of this prospect i ve clinical study demonstrate that sacral neuromodulation is a safe and effective treatment for the dysfunctional voiding and pelvic pain in patients with interstitial cystitis who are refractory to other forms of treatment We evaluated the efficacy of bilateral caudal epidural sacral neuromodulation for the treatment of refractory chronic pelvic pain ( CPP ) , painful bladder syndrome , and interstitial cystitis ( IC ) . Thirty consecutive patients ( 21 female , 9 male ) with severe refractory symptoms underwent bilateral S2-S4 sacral neuromodulation for CPP/IC . Patients were evaluated with the O'Leary IC symptom and problem index ( ICSI , ICPI ) , the short form of the Urogenital Distress Inventory ( UDI-6 ) , and the R AND 36-item health survey ( SF-36 ) preoperatively and 6 months postoperatively . The mean and minimum follow-up were 15 and 6 months , respectively . Of the 30 patients , 23 ( 77 % ) had a successful trial stimulation and were permanently implanted . Among these patients , the ICSI and ICPI scores improved by 35 ( p = 0.005 ) and 38 % ( p = 0.007 ) , respectively . The pain score improved by 40 % ( p = 0.04 ) and the UDI-6 score by 26 % ( p = 0.05 ) . On average , patients reported a 42 % improvement in their symptoms . SF-36 scores did not improve significantly . In refractory patients , bilateral caudal epidural sacral neuromodulation is another possible mode of treatment , which appears to improve both pelvic pain and voiding symptoms PURPOSE We assess the efficacy of intravesical administration of oxybutynin chloride in patients with interstitial cystitis . MATERIAL S AND METHODS The study included 36 women with a mean age of 45 years with a diagnosis of interstitial cystitis . Patients were treated with gradual intravesical instillation of saline oxybutynin solution ( oxybutynin group ) or gradual filling of simple saline ( control group ) . Evaluation parameters consisted of symptom problem index , voids per day , volume per void , functional bladder capacity , volume at first sensation , cystometric bladder capacity and cystometric volume at first sensation . RESULTS Statistically significant improvement of all evaluated parameters was found in both groups . When comparing the outcomes statistically significant improvement of parameters favored the oxybutynin group . CONCLUSIONS Bladder training alone produces a satisfactory result by gradually exp and ing the bladder , and an additional statistically significant improvement is evident with intravesical oxybutynin PURPOSE We examined the efficacy of Suplatast Tosilatedouble dagger ( IPD-1151 T ) , a new immunoregulator that suppresses helper T cell mediated allergic responses , including IgE production and eosinophilic inflammation for treating patients with interstitial cystitis . MATERIAL S AND METHODS A total of 14 women ( average age 43.7 years ) with interstitial cystitis , which was nonulcerative in 13 and ulcerative in 1 , were treated with 300 mg . IPD-1151 T orally daily for 12 months . All patients received laboratory assessment s , including hematology ( eosinophils and CD20 positive cells ) and serum chemistry ( IgE , and interleukin-4 ( IL-4 ) and 5 , and immunohistochemical analyses of urine leukocytes ( CD45RO positive cells as a T cell marker ) before treatment . These parameters were also measured 4 and 12 months after continuous treatment . The voiding chart , and interstitial cystitis symptom and problem indexes were evaluated before and after IPD-1151 T treatment . RESULTS IPD-1151 T treatment for 1 year result ed in a significantly increased bladder capacity and decreased symptoms , such as urinary urgency , frequency and lower abdominal pain , in patients with nonulcerative interstitial cystitis . These effects also correlated with a reduction in blood eosinophils , CD20 positive cells and IgE , and urine CD45RO positive memory T cells . No major side effects were observed . CONCLUSIONS Our study suggests that immunological responses are involved in the development of interstitial cystitis symptoms . IPD-1151 T could be a new oral agent for treatment of voiding symptoms and bladder pain in patients with interstitial cystitis PURPOSE We evaluated the safety and efficacy of intravesical liposomes , a mucosal protective agent , compared to oral pentosan polysulfate sodium for interstitial cystitis/painful bladder syndrome . MATERIAL S AND METHODS We performed a prospect i ve longitudinal study of the effect of 2 independent treatments ( intravesical liposomes and oral pentosan polysulfate sodium ) in patients with interstitial cystitis/painful bladder syndrome . Ten possible responses ( or measures ) to treatment were monitored at 3 time points , including baseline , and weeks 4 and 8 . A total of 24 patients with interstitial cystitis/painful bladder syndrome were evaluated in a 1:1 ratio to intravesical liposomes ( 80 mg/40 cc distilled water ) once weekly or to oral pentosan polysulfate sodium ( 100 mg ) 3 times daily for 4 weeks each . RESULTS No patient had urinary incontinence , retention or infection due to liposome instillation . There were no unanticipated adverse events and no significant worsening of symptoms during followup . Statistically significant decreases in urinary frequency and nocturia were observed in each treatment group . Statistically significant decreases in pain , urgency and the O'Leary-Sant symptom score were observed in the liposome group . Decreased urgency in the liposome group had the most profound effect of the ordinal measures . CONCLUSIONS Each glycosaminoglycan directed treatment seemed beneficial . Liposome intravesical instillation is safe for interstitial cystitis/painful bladder syndrome with potential improvement after 1 course of therapy for up to 8 weeks . Intravesical liposomes achieved efficacy similar to that of oral pentosan polysulfate sodium . Further large-scale placebo controlled studies are needed . Intravesical liposomes appear to be a promising new treatment for interstitial cystitis/painful bladder syndrome Objective To evaluate the efficacy of oral cimetidine as a treatment for  painful bladder disease ( PBD , variously described as a ‘ symptom complex ’ of suprapubic pain , frequency , dysuria and nocturia in the absence of overt urine infection ) by assessing symptom relief and histological changes in the bladder wall tissue components , compared with placebo PURPOSE We evaluated the 1-year efficacy and tolerability of botulinum A toxin intravesically injected in patients with painful bladder symptoms associated with increased urinary frequency , refractory to conventional treatments . MATERIAL S AND METHODS Three men and 12 women were prospect ively included in the study . Under short general anesthesia the patients were given injections of 200 U commercially available botulinum A toxin diluted in 20 ml 0.9 % NaCl . Injections were performed submucosally in the bladder trigone and lateral walls under cystoscopic guidance . A voiding chart and the visual analog scale for pain were used , and urodynamics were performed before treatment , and 1 , 3 , 5 and 12 months later . RESULTS Overall 13 patients ( 86.6 % ) reported subjective improvement at the 1 and 3-month followups . The mean visual analog scale score , and daytime and nighttime urinary frequency were significantly decreased ( p < 0.05 , < 0.01 and < 0.05 , respectively ) . At the 5-month followup the beneficial effects persisted in 26.6 % of cases but increased daytime and nighttime urinary frequency , and an increased visual analog scale score were observed compared to baseline . At 12 months after treatment pain recurred in all patients . Nine patients complained of dysuria 1 month after treatment . Dysuria persisted in 4 cases at the 3-month followup and in 2 at the 5-month followup . CONCLUSIONS Intravesically injected botulinum toxin A is effective for short-term management of refractory painful bladder syndrome . The beneficial effects decreased progressively within a few months after treatment . Thus , repeat injections of the neurotoxin are required for efficacious treatment in patients with the disease PURPOSE Nitric oxide synthase activity is decreased in the urine of patients with interstitial cystitis compared to the urine of controls . In a preliminary trial oral L-arginine , the substrate for nitric oxide synthase , increased urinary nitric oxide synthase activity and improved interstitial cystitis symptoms . This r and omized , double-blind , placebo controlled study further investigates the efficacy of L-arginine treatment for interstitial cystitis . MATERIAL S AND METHODS A total of 53 interstitial cystitis patients were assigned to receive daily 1,500 mg . L-arginine or placebo orally for 3 months . Interstitial cystitis symptoms were assessed by interviews at 2 weeks , and 1 , 2 and 3 months . RESULTS The trial was completed by 21 of 27 patients in the L-arginine group and 25 of 26 in the placebo group . Using per protocol analysis 29 % ( 6 of 21 patients ) in the L-arginine group and 8 % ( 2 of 25 ) in the placebo group were clinical ly improved by the end of the trial ( p = 0.07 ) . A Likert scale showed greater global improvement in the L-arginine group ( 48 % , 10 of 21 ) compared to the placebo group ( 24 % , 6 of 25 ) at 3 months ( p = 0.05 ) with a decrease in pain intensity ( p = 0.04 ) , and tendency toward improvement in urgency ( p = 0.06 ) and frequency of pain ( p = 0.09 ) . Using an intention to treat approach to analysis there were no differences between groups . CONCLUSIONS Oral L-arginine ( 1,500 mg . daily ) may decrease pain and urgency in a subset of interstitial cystitis patients PURPOSE We report an observational study to evaluate the efficacy and tolerability of duloxetine for interstitial cystitis . MATERIAL S AND METHODS A total of 48 women were prospect ively treated for 2 months following an uptitration protocol to the target dose of 2 x 40 mg duloxetine per day . Patients received the target dose for 5 weeks . The efficacy of duloxetine treatment was assessed at week 8 . The primary end point was a change in the overall well-being evaluated by a patient reported global response assessment . Secondary end points were changes in pain and urgency ( visual analog scales ) , frequency and functional bladder capacity ( 48-hour voiding log ) , and changes in overall symptom severity ( O'Leary-Sant index ) . RESULTS There were 5 patients ( 10.4 % ) who were identified as responders and 17 patients ( 35.4 % ) who dropped out of the study exclusively due to side effects , with nausea present in all dropouts . No severe adverse events were reported . All 5 responders reported onset of symptom improvement but not until they had reached the target dose . Regarding secondary outcome parameters , duloxetine treatment did not result in statistically significant improvement of symptoms . Maximum urinary flow rate and residual volume were influenced more prominently in patients at the target dose , however , the changes did not appear to be clinical ly meaningful . CONCLUSIONS Treatment of interstitial cystitis with duloxetine did not result in significant improvement of symptoms . The drug administration was safe but the tolerability of the drug was poor mainly due to nausea occurring with the starting dose of 20 mg per day . Based on the preliminary data of this observational trial we currently can not recommend duloxetine as a therapeutic approach for interstitial cystitis OBJECTIVES Interstitial cystitis ( IC ) is a chronic , debilitating condition that is often associated with late diagnosis and a delay in initiation of appropriate IC-specific therapy . The purpose of this study was to determine whether the length of time from initial diagnosis to start of treatment impacts subsequent symptom improvement . METHODS A retrospective analysis was conducted in 128 patients with IC who had been treated with pentosan polysulfate sodium ( PPS ) 300 mg/day for 32 weeks in a multicenter , r and omized , double-blind , parallel-group clinical trial . Outcome measures included the O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) and the O'Leary-Sant Interstitial Cystitis Problem Index ( ICPI ) . Early treatment was defined as treatment initiation 6 months or less after IC diagnosis , whereas late treatment was defined as treatment initiation 24 months or more after IC diagnosis . Efficacy data were analyzed by using the intent-to-treat , last-observation-carried-forward population . RESULTS At the end of the study , mean changes from baseline in total ICSI and ICPI scores ( + /- SEM ) for early treatment ( 6 months or less ) versus late treatment ( 24 months or more ) were 3.97 + /- 0.59 versus 2.15 + /- 0.70 ( P = 0.0472 ) and 3.94 + /- 0.56 versus 1.77 + /- 0.63 ( P = 0.0117 ) , respectively . Similar trends for both measures were observed when examining other times from IC diagnosis ( 3 months or less versus 24 months or more , 3 months or less versus 36 months or more , and 6 months or less versus 36 months or more ) . CONCLUSIONS Initiation of PPS treatment within 6 months of establishing the diagnosis of IC may be associated with greater improvement in patient symptoms and symptom bother OBJECTIVE The goal of this pilot study was to gather information on differences between intravesical chondroitin sulfate and inactive vehicle control for treatment of interstitial cystitis/painful bladder syndrome ( IC/PBS ) . METHODS This was a prospect i ve , r and omized , double-blind , inactive vehicle-controlled , 12-week study ( 6-week treatment period , followed by a 6-week follow-up period ) in patients with IC/PBS . Patients were r and omized to weekly intravesical treatment with 2.0 % sodium chondroitin sulfate in phosphate-buffered saline or intravesical vehicle control . Primary efficacy analysis compared responders ( moderately or markedly improved ) according to the 7-point Global Response Assessment . Secondary endpoints include question naires focused on symptoms and quality of life . RESULTS Sixty-five evaluable patients were r and omized . At the primary endpoint analysis ( week 7 ) , 22.6 % of the vehicle control group were responders compared with 39.4 % of the active therapy group ( P = .15 ) . There was no statistically significant difference for any of the secondary endpoints . Overall , 76.9 % of the patients in the study reported at least 1 adverse event ; most were mild or moderate , the majority associated with the vehicle control treatment . Nine nonserious intervention-related adverse events were reported in 3 patients in the vehicle control group compared with 2 in 1 patient in the active treatment group . CONCLUSION The difference in treatment effect in this small underpowered study was not statistically significant , although twice as many patients reported a clinical ly significant benefit with intravesical chondroitin sulfate treatment compared with vehicle control treatment . This trial provides data required to design a well-powered r and omized vehicle-controlled trial to determine the true efficacy of this potentially promising therapy
target: Meta- analysis of RCTs showed that only cyclosporine A provided a simultaneous great effect size of SMD on ICSI , pain , and frequency .
  Amitriptyline at different dosages showed a great effect size of SMD on pain and urgency or on ICSI and frequency .
  The results from the n RCTs showed that the most frequently adopted treatment is oral pentosan polysulfate and that the use of botulinum A toxin intradetrusorial injections in PBS/IC is increasing .
  Limited evidence exists for the few treatments for PBS/IC .
  The lack of definitive conclusions is due to the great heterogeneity in methodology , symptoms assessment , duration of treatment , and follow-up in both RCTs and n RCTs
background: CONTEXT Different types of behavioural , dietary , interventional , pharmacologic , and surgical therapies have been used to treat painful bladder syndrome/interstitial cystitis ( PBS/IC ) .
  Because of the paucity of r and omised placebo-controlled studies on different treatments , an evidence -based management approach has not yet been developed .
  OBJECTIVE To critically review and synthesize data from a wide range of current therapeutic approaches to PBS/IC , to quantify the effect size from r and omised controlled trials ( RCTs ) , and to reach clinical agreement on the efficacy of treatments for PBS/IC .