Laparoscopic colposuspension versus vaginal suburethral slingplasty: a randomised prospective trial. Laparoscopic Burch colposuspension: a randomized controlled trial comparing two transperitoneal surgical techniques. A randomised trial comparing open Burch colposuspension using sutures with laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence. Cost-analyzes based on a prospective, randomized study comparing laparoscopic colposuspension with a tension-free vaginal tape procedure. Prospective randomised controlled trial comparing laparoscopic and open colposuspension. A three-armed randomized trial comparing open Burch colposuspension using sutures with laparoscopic colposuspension using sutures and laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence. Laparoscopic versus open Burch colposuspension: a randomised controlled trial. Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial. Endoscopic retropubic colposuspension: "Retziusscopy" versus laparoscopy--a reasonable enlargement of the operative spectrum in the management of recurrent stress incontinence? Prospective comparison of laparoscopic and traditional colposuspensions in the treatment of genuine stress incontinence. Randomized prospective comparison of needle colposuspension versus endopelvic fascia plication for potential stress incontinence prophylaxis in women undergoing vaginal reconstruction for stage III or IV pelvic organ prolapse. The Continence Program for Women Research Group. Tension-free vaginal tape and laparoscopic mesh colposuspension for stress urinary incontinence. Comparison of the efficacy of Burch colposuspension, pubovaginal sling, and tension-free vaginal tape for stress urinary incontinence.
This study aimed to determine if laparoscopic colposuspension (LC) was as effective as vaginal suburethral slingplasty (SPARC).
                Ninety-seven women with urodynamic stress incontinence were prospectively randomised to LC (n=48) or SPARC (n=49). Outcome measures were measured at, baseline, six months (n=87) and two years (n=58), and comprised leakage episodes per week and visual analogue scale (VAS) of incontinence severity. The LC and SPARC groups at baseline had similar leaks per week (8.8 vs 9.8) and VAS (5.6 vs 5.9).
                Laparoscopic colposuspension took longer to perform (48 vs 30 mins, P<0.001), had a slightly higher blood loss (104 vs 82 mL, P<0.01), had a longer hospitalisation (4.0 vs 1.5 days, P<0.001) and had a longer time to resumption of normal activities (3.6 vs 2.8 week, P<0.01). At six months there were no significant differences between LC and SPARC with regard to leaks per week (1.1 vs 2.6) and VAS (1.3 vs 0.7). The success rates were similar (88.3 vs 81.8%). These results again had no significant differences at two years (leaks per week 2.1 vs 3.5, and VAS 1.7 vs 2.2). At two years, the cure/improved rates again found no significant difference (81.5 vs 77.4%)
                Laparoscopic colposuspension is as effective as vaginal suburethral slingplasty after two years' follow-up. To compare the effectiveness of two transperitoneal laparoscopic Burch procedures.
                The sample size required was 30 subjects per group to detect a statistically significant estimated difference of 15% between two surgical procedures with an alpha = 0.05 and a power of 0.7. Sixty women affected by genuine stress incontinence (GSI) were enrolled and randomly assigned to two groups of 30 women each. All women were treated with the transperitoneal laparoscopic Burch procedure using nonabsorbable sutures (group A) or Prolene mesh (Ethicon, Somerville, NJ) fixed with tacks or staples (group B). The failure rate was defined subjectively and objectively. The subjective evaluation was performed by asking the women to rate their urine loss on a visual analog scale. The objective evaluation was a clinical evaluation using multichannel urodynamic studies.
                The subjective failure rate was not significantly different between the two groups at 3 months (0% for both groups), 6 months (3.7% versus 3.8% for groups A and B, respectively), and 12 months (7.4% versus 15.4% for groups A and B, respectively) after surgery. At 3 months (3.7% versus 3.8% for groups A and B, respectively) and 6 months (7.4% versus 15.4% for groups A and B, respectively) follow-up, the objective failure rate was not significantly different between the two groups. However, at 12 months after the surgical procedure, the objective failure rate was significantly lower in group A than in group B (11.1% versus 26.9%, respectively; P <.05).
                Transperitoneal laparoscopic Burch colposuspension performed using sutures was more effective than the mesh technique. To compare open Burch colposuspension using sutures with laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence.
                Multicentre, prospective randomised trial.
                Departments of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Göteborg, Borås County Hospital and Orebro University Hospital, Sweden.
                Women with genuine stress urinary incontinence or mixed incontinence with a predominantly stress component were included, and were randomised to either open colposuspension (n= 120) or laparoscopic colposuspension (n= 120).
                Women were randomised to open colposuspension with sutures or laparoscopic colposuspension with polypropylene mesh and staples. Anaesthesia/operation time, blood loss, complications and other related surgical parameters were compared.
                Objective and subjective cure rates from 48-hour frequency-volume chart, a 48-hour pad test and a subjective assessment of the woman's incontinence and quality of life performed one year after surgery.
                Objective and subjective cure rates were higher after open compared with laparoscopic colposuspension (P < 0.001). Quality of life was improved following surgery in both groups (P < 0.0001) and the improvement was significantly greater in the open colposuspension group (P < 0.05) with regard to physical activity. Performing an open colposuspension was less time consuming (P < 0.0001), resulted in more blood loss (P < 0.0001), longer catheterisation time (P < 0.01), greater risk of urinary retention (P < 0.01) and a longer hospital stay (P < 0.0001) compared with performing a laparoscopic colposuspension. The rate of serious complications was low in both groups.
                Open colposuspension had a higher objective and subjective cure rate one year after surgery but with a greater blood loss, greater risk of urinary retention and a longer hospital stay than laparoscopic colposuspension. The aim of this study was to compare laparoscopic colposuspension with tension-free vaginal tape (TVT) in terms of costs to the county.
                In a prospective, randomized study, we approached 270 consecutive women presenting for evaluation of stress urinary incontinence symptoms at one university hospital. Preoperatively, and at 1-year follow-up, the women underwent urodynamic evaluation, an ultra-short pad-test and completed a lower urinary tract symptoms questionnaire. We randomized 79 consenting, eligible women to either procedure; a 1-year follow-up examination was performed on 68/71 (96%) women that were available. The procedures were performed as described previously. Main outcome measures were all relevant costs for goods and services associated with the procedures.
                The baseline characteristics of the two groups were similar. The TVT procedure was performed significantly faster than the laparoscopic colposuspension, i.e. 44.9 +/- 14.2 min compared with 60.5 +/- 13.4 min (p < 0.0001). Even so, procedural costs were significantly lower for laparoscopic colposuspension than for TVT (euro 1273.4 compared with euro 1342.8 p < 0.001). At the 1-year follow-up visit, three women operated on with TVT and one operated on with laparoscopic colposuspension required re-operation for continuous stress urinary incontinence. One women operated on with TVT had her sling cut for bladder-emptying problems. Total costs, including re-operations were euro 1462.6 for a TVT procedure andeuro; 1314.5 for a laparoscopic colposuspension.
                In our hands, the laparoscopic colposuspension was less expensive to the county than the TVT procedure. To compare the efficacy, safety, complications, and short-term outcome of laparoscopic and open colposuspension in women with genuine stress incontinence.
                Randomised controlled trial.
                Urogynaecology unit in a public hospital, Hong Kong.
                Ninety patients with urodynamically proven genuine stress incontinence. Forty-three patients were randomly allocated to receive open colposuspension and 47 to undergo laparoscopy. All patients had reassessment within 1 year of the operation.
                Objective and subjective measures and complication rates.
                There was no significant difference in the duration of stress incontinence, mean preoperative pad test results, or proportion with pre-existing detrusor instability. Among patients in the laparoscopic group, the mean operating time was significantly longer (42.0 minutes versus 29.3 minutes; P<0.0001), while the mean blood loss was significantly less (124.7 mL versus 326.9 mL; P=0.001). Subjective and objective success rates within 1 year were similar for patients in the open and laparoscopic groups (86.0% versus 80.9%; P=0.58, and 86.0% versus 85.1%; P=1.00, respectively). There was no significant difference in the rate of complications, including de novo detrusor instability and an obstructive voiding pattern, enterocele, or dyspareunia.
                Laparoscopic colposuspension is a feasible alternative to the open approach. The operating time is longer but the short-term cure rate is comparable with that of the open approach. To compare open Burch colposuspension using sutures (OC) with laparoscopic colposuspension using sutures (LCS) and laparoscopic colposuspension using mesh and staples (LCM) in women with stress urinary incontinence.
                Prospective randomized trial. Setting: Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Göteborg, Sweden.
                Women with genuine stress urinary incontinence or mixed incontinence with a predominantly stress component attending the Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Göteborg, Sweden.
                The women were assessed objectively using a 48-h frequency-volume chart, a 48-h pad test and a standardized stress test. Subjectively, the women were assessed by a questionnaire including influence on quality of life. The women were randomized to OC using sutures (n = 79), LCS (n = 53) or LCM (n = 79). Anaesthesia/operation time, blood loss, complications and other related surgical parameters were compared. Main outcome measures. Objective and subjective cure rate.
                Objective cure rates 1 year after surgery were significantly higher in the OC and LCS groups compared to the LCM group analyzed by a standardized stress test. Subjective findings were in concordance with the objective results. Performing an OC was less time consuming than performing a LCS and resulted in more blood loss compared to the two laparoscopic techniques. Patients in the LCM group had a shorter duration of catheter use and hospital stay.
                The use of sutures, irrespective of whether the surgical approach was laparoscopic or open surgery, was superior to the laparoscopic mesh and staple technique. To compare perioperative characteristics, short-term, and long-term outcomes for laparoscopic Burch colposuspension (LBC) and open Burch colposuspension (OBC) for the treatment of urinary stress incontinence.
                Randomised surgical trial with single blinding.
                Three tertiary level teaching hospitals involving seven surgeons of varying skill levels.
                Two hundred women with urodynamic stress incontinence (USI).
                The two groups were treated in identical fashion, except for the laparoscopic or open approach to surgery. Attempts were made to blind the subjects and the observers obtaining outcome data to treatment group. Analyses were adjusted for surgeon experience.
                Absence of USI 6 months following surgery, postoperative pain, time spent in hospital, and time to return to activities of normal daily living.
                There were no significant differences in objective and subjective measures of cure and in patient satisfaction at 6 months, 24 months, or 3-5 years of follow up between laparoscopic and open colposuspension groups. Laparoscopic colposuspension took longer time to perform (87 versus 42 minutes, P< 0.0001) but was associated with less blood loss (P = 0.03), less pain (P = 0.02), and quicker return to normal activities (P = 0.01).
                LBC has significant advantages over traditional OBC, without any apparent compromise in short-term and long-term outcomes. To compare perioperative characteristics, short-term, and long-term outcomes for laparoscopic Burch colposuspension (LBC) and open Burch colposuspension (OBC) for the treatment of urinary stress incontinence. Randomised surgical trial with single blinding. Three tertiary level teaching hospitals involving seven surgeons of varying skill levels. Two hundred women with urodynamic stress incontinence (USI). The two groups were treated in identical fashion, except for the laparoscopic or open approach to surgery. Attempts were made to blind the subjects and the observers obtaining outcome data to treatment group. Analyses were adjusted for surgeon experience. Absence of USI 6 months following surgery, postoperative pain, time spent in hospital, and time to return to activities of normal daily living. There were no significant differences in objective and subjective measures of cure and in patient satisfaction at 6 months, 24 months, or 3-5 years of follow up between laparoscopic and open colposuspension groups. Laparoscopic colposuspension took longer time to perform (87 versus 42 minutes, P < 0.0001) but was associated with less blood loss (P= 0.03), less pain (P= 0.02), and quicker return to normal activities (P= 0.01). LBC has significant advantages over traditional OBC, without any apparent compromise in short-term and long-term outcomes. To compare the laparoscopic Burch colposuspension with the tension-free vaginal tape procedure (TVT) for efficacy.
                Seventy-two women from 2 institutions were randomized: 36 to laparoscopic Burch colposuspension and 36 to TVT. Multichannel urodynamic tests were performed preoperatively and 1 year after surgery. A research nurse administered the Urogenital Distress Inventory, Incontinence Impact Questionnaire, and pelvic examinations using the pelvic organ prolapse quantification system preoperatively, and at 6 months, 1 year, and 2 years after surgery. Voiding diaries were collected at 1 and 2 years. Primary outcome was objective cure, which was defined as no evidence of urinary leakage during postoperative urodynamic studies. Secondary outcomes included subjective continence, perioperative and postoperative data, and quality of life.
                Thirty-three laparoscopic Burch colposuspension and 33 TVT patients were analyzed with a mean follow-up of 20.6 +/- 8 months (range 12-43). Mean operative time was significantly greater in the laparoscopic Burch colposuspension group compared with the TVT group, 132 versus 79 minutes, respectively (P = .003). Multichannel urodynamic studies in 32 laparoscopic Burch colposuspension and 31 TVT patients showed a higher rate of urodynamic stress incontinence at 1 year in the laparoscopic Burch colposuspension group, 18.8% versus 3.2% (P = .056). There was a significant improvement in the number of incontinent episodes per week and in Urogenital Distress Inventory and Incontinence Impact Questionnaire scores in both groups at 1 and 2 years after surgery (P < .001). However, postoperative subjective symptoms of incontinence (stress, urge, and any urinary incontinence) were reported significantly more often in the laparoscopic Burch colposuspension group than in the TVT group (P < .04 for each category).
                The TVT procedure results in greater objective and subjective cure rates for urodynamic stress incontinence than does laparoscopic Burch colposuspension. The technical feasibility of the laparoscopic and extraperitoneal approach to the Burch colposuspension for treatment of grade II and III (moderate to severe) stress incontinence was examined in a randomised prospective study. Irrespective of the endoscopic access, two suspension techniques, namely conventional suture and stapler fixation of alloplastic materials, were compared. A total of 20 patients entered this preliminary evaluation. Three complications occurred; a bladder perforation (during laparoscopic dissection of the space of Retzius), a postoperative detrusor instability and transient urinary retention. Both the endoscopic approaches and the suspension procedures employed proved feasible and safe, and presented the advantages of a "minimal access" procedure, with short hospitalisation and rapid recovery. Short-term follow-up (6-12 months) showed subjective and objective results comparable to those of the conventional abdominal Burch colposuspension. Detailed evaluation of the subgroups is not yet feasible, as the number of patients in this preliminary evaluation was too small and follow-up too short. Final evaluation of the entire study population and long-term follow-up will be necessary before these procedures can be generally offered as a therapeutic alternative. To compare prospectively the results of laparoscopic and traditional colposuspensions in the treatment of genuine stress incontinence and to evaluate the efficacy, technique, and functional and anatomical changes after these two procedures.
                Ninety-two patients with urodynamically proven genuine stress incontinence participated in this study, with 46 patients randomly allocated to laparoscopic colposuspension, and the other 46 patients to the traditional procedures. All patients had repeat studies at least 3 months after operation.
                The bladder neck position was significantly elevated after operation either at rest or during straining in both groups (all p < 0.001), but it was higher in the traditional group than the laparoscopy group during straining (p < 0.05). Comparison of urodynamics before and after operation in both groups showed significantly increased minimal urethral resistance and improved pressure transmission ratios at the proximal urethra (Q2). The blood loss was less in the laparoscopy group. The duration of bladder drainage after laparoscopic colposuspension was shorter, and was not affected by subsequent laparotomy. The operative time was almost the same. The success rate of the laparoscopy group was lower than that of the traditional group (80.4% vs. 95.6%, p = 0.044). The complication rates were 10.8% and 17.4% respectively.
                Laparoscopic colposuspension is an effective method for the treatment of GSI, as documented by anatomical and functional assessments. However, the success rate is still lower than for the traditional procedure. Severe prolapse may mask potential genuine stress urinary incontinence in women. Some have suggested that a suspending urethropexy be performed in women who have potential genuine stress incontinence demonstrated by barrier reduction of the prolapse preoperatively. Our aim was to compare outcomes after prolapse surgery that included a formal bladder neck suspension with those operations that did not.
                This prospective randomized clinical trial assigned 32 women with bladder neck hypermobility and stage III or IV pelvic organ prolapse to receive either a needle colposuspension or bladder neck endopelvic fascia plication as part of the vaginal reconstructive surgery. Twenty-nine subjects underwent detailed clinical, anatomic, urodynamic, and quality-of-life evaluations before and 6 weeks and 6 months after surgery; 23 completed urinary diary and quality-of-life evaluations after a mean of 2.9 years.
                Needle colposuspension increased short-term complications without providing additional protection from de novo stress incontinence. Barrier testing before surgery predicted urethral sphincteric resistance after surgery; however, such testing neither predicted a patient's function after surgery nor indicated the need for a suspending urethropexy. The combination of a needle colposuspension with a sacrospinous ligament suspension predisposed to the early development of support defects of the upper anterior vaginal segment and to failure of bladder neck support.
                Preoperative barrier testing in women with severe prolapse is not useful in identifying individuals who require a suspending urethropexy. Needle colposuspension increases short-term complications, lacks durability, and may predispose to early and severe recurrent anterior prolapse when performed with a sacrospinous ligament vault suspension. To compare objective and subjective outcomes after the tension-free vaginal tape procedure (TVT) with laparoscopic mesh colposuspension as a primary treatment for female stress urinary incontinence. Objective outcome measures were stress test and 48-hour pad test.
                In 6 departments of gynecology in Finland, including 4 university teaching hospitals and 2 central hospitals, 128 women with urodynamic stress incontinence were randomly allocated to 2 treatment groups. Seventy were treated with TVT and 51 by means of laparoscopic mesh colposuspension. There were 7 dropouts. Inclusion criteria were history of stress incontinence, positive stress test, and urodynamic conformation of stress incontinence. Exclusion criteria were age older than 70 years, previous incontinence surgery, more than 3 episodes of urinary tract infection within the last 2 years, coincident other gynecological surgery, body mass index more than 32 kg/m(2), urethral closure pressure less than 20 cm H(2)O, and residual volume more than 100 mL in preoperative urodynamic evaluation. Assessment took place before treatment and at 12 months postoperatively with the cough stress test, Urge Score, 48-hour pad test, King's College Health Questionnaire, Visual Analog Scale, and Urinary Incontinence Severity Score.
                When negative stress test was used as criteria for cure, 85.7% of women in the TVT group and 56.9% in the laparoscopic mesh colposuspension group were objectively cured. Subject satisfaction was significantly better after the TVT procedure than after laparoscopic mesh colposuspension.
                Treatment with TVT results in higher objective and subjective cure rates at 1 year than treatment by means of laparoscopic mesh colposuspension. To compare the cure rate and confirm the clinical efficacy of the 3 most frequently performed surgical procedures for stress urinary incontinence (SUI).
                Between January 2001 and May 2003, 92 women with SUI were randomly assigned to undergo the Burch colposuspension (n=33), pubovaginal sling (n=28), or tension-free vaginal tape (n=31) at the Department of Obstetrics and Gynecology, Yonsei Medical Center, Seoul, Korea. Patient characteristics, urodynamic study results, cure rates at 3, 6, and 12 months, and complication rates were compared using the chi2 test.
                There were no statistically significant differences in the cure rates initially, but after 12 months the cure rate of the pubovaginal sling procedure was found to be significantly higher than those of the tension-free vaginal tape or Burch colposuspension procedures.
                The cure rate of the pubovaginal sling procedure was significantly higher after 1 year, but no difference in efficacy was observed between the 2 other procedures. A randomized prospective study of a larger population should be conducted.
Currently available evidence suggests that laparoscopic colposuspension may be as good as open colposuspension at two years postsurgery. However, the newer vaginal sling procedures appear to offer even greater benefits, better objective outcomes in the short term and similar subjective outcomes in the longer term. If laparoscopic colposuspension is performed, the use of two paravaginal sutures appears to be the most effective method. The place of laparoscopic colposuspension in clinical practice should become clearer when there are more data available describing long-term results.