title: Single-blind, multicenter, placebo controlled, parallel study to assess the safety and efficacy of intralesional interferon alpha-2B for minimally invasive treatment for Peyronie's disease. The impact of intralesional interferon alpha-2b injection therapy on penile hemodynamics in men with Peyronie's disease. Treatment of Peyronie's disease with local interferon-alpha 2b. Clinical Efficacy of Injection and Mechanical Therapy for Peyronie's Disease: A Systematic Review of the Literature.
abstract: PURPOSE We investigated the efficacy and safety of intralesional interferon alpha-2b for the treatment of Peyronie 's disease . MATERIAL S AND METHODS A total of 117 consecutive patients with a mean age of 55.1 years who had Peyronie 's disease were enrolled in a single-blind , multicenter , placebo controlled , parallel study to determine the efficacy and safety of intralesional interferon alpha-2b therapy ( Schering , Kenilworth , New Jersey ) , including 62 who received placebo and 55 who received interferon alpha-2b . Saline ( 10 ml ) in controls and interferon alpha-2b ( 5 x 10(6 ) U ) were administered biweekly for 12 weeks . Each patient was evaluated for penile curvature , plaque size and density , penile pain , erectile function and penile hemodynamics before and after study completion . Improvement in these parameters was statistically compared between the groups . RESULTS A total of 53 patients in the control arm and 50 in the interferon alpha-2b arm completed the study . Improvement in penile curvature , plaque size and density , and pain resolution was significantly greater in patients treated with interferon alpha-2b vs placebo . The increase in mean International Index of Erectile Function scores was not significantly different between the groups . Penile blood flow improvement was observed in interferon alpha-2b treated patients but not in those who received placebo . The decrease in the number of penile vascular pathologies was significantly higher in interferon alpha-2b cases . Side effects , mostly flu-like symptoms , which were frequently noted in patients on interferon alpha-2b , were mild to moderate in degree and of short duration . CONCLUSIONS This single-blind , multicenter , placebo controlled , parallel study demonstrates that intralesional interferon alpha-2b at a dose of 5 x 10(6 ) units biweekly for 12 weeks is effective and safe as minimally invasive therapy for Peyronie 's disease INTRODUCTION Penile duplex Doppler ultrasound ( PDDU ) is currently the preferred method for the functional evaluation of penile hemodynamics . PDDU may be used to monitor objective ly changes in penile vascular parameters in men who undergo treatment for Peyronie 's disease ( PD ) , including intralesional interferon alpha-2b ( IFN alpha-2b ) . AIM To investigate the impact of intralesional IFN alpha-2b therapy for PD on penile hemodynamics by using PDDU and to assess the objective role of PDDU in monitoring treatment outcomes . MATERIAL S AND METHODS Thirty-nine patients ( 20 in the placebo and 19 in the IFN alpha-2b treatment arm ) were enrolled in this prospect i ve , placebo-controlled , parallel study . Patients received either 10 mL saline or 5 x 10(6 ) units of IFN alpha-2b intralesional injections every other week for a total of six injections . Patients in each group were evaluated at baseline and after completion of treatment regarding changes in penile hemodynamic parameters , penile curvature , plaque size and density , pain on erection , and erectile function . Specific published criteria were used for PDDU measurements . Outcomes were statistically compared between each group by using Mann-Whitney U and chi-square tests . RESULTS The mean age of the patients and the duration of PD were similar in both groups . The improvement in penile blood flow was significantly greater in IFN alpha-2b-treated patients than those in the placebo group . The number with the nonvascular classification increased significantly in the IFN alpha-2b arm from 31.5 % to 57.8 % . Additionally , improvements in penile curvature , plaque size and density , and pain on erection were better in the IFN alpha-2b group compared with the control . No significant improvement was observed in the erectile function domain in either group . CONCLUSION This study reveals that intralesional IFN alpha-2b injections have a significant benefit on penile hemodynamic parameters . Moreover , intralesional IFN alpha-2b is an effective , minimally invasive treatment for PD , and PDDU is a useful adjunct to monitor objective ly changes in penile vascular parameters . interferon alpha-2b injection therapy on penile hemodynamics in men with Peyronie 's disease OBJECTIVE To evaluate the efficacy of subcutaneous interferon-alpha 2b in the treatment of Peyronie 's disease . PATIENTS AND METHODS Twenty-three men ( mean age 53 years , range 27 - 69 ) received interferon-alpha 2b in an unr and omized prospect i ve study . The drug was injected subcutaneously adjacent to the plaque three times a week for 3 weeks at a dose of 2 x 106 IU . The effect of interferon-alpha 2b on the extent of penile deviation , plaque size and erectile pain were investigated , and the drug 's side-effects were documented . The mean ( range ) follow-up was 22 ( 4 - 48 ) months RESULTS All patients had pain relief and 13 of 19 with pain before treatment became pain-free . The penile deviation was reduced in one patient ; the deviation increased despite therapy in one patient and remained stable in the others . Plaque size remained unchanged in all patients . Impaired sexual function was improved in seven ( 30 % ) of the patients . Side-effects ( myalgia , fever ) occurred after only four of 207 injections ( 2 % ) . CONCLUSIONS Subcutaneous interferon-alpha 2b is safe , well tolerated and relieves pain . However , with no objective reduction in penile deviation and plaque size , the outcome of interferon-alpha 2b therapy is generally unconvincing and the drug can not be recommended for the conservative treatment of Peyronie 's disease CONTEXT Conservative therapies for Peyronie 's disease ( PD ) aim to treat early-stage disease by improving clinical outcomes such as penile curvature , penile length erectile dysfunction , and pain . OBJECTIVE To summarise the available evidence regarding injection and mechanical therapies for PD treatment . EVIDENCE ACQUISITION An extensive search of Medline , Embase , and Scopus data bases retrieved English- language articles up to 15 May 2018 . The systematic review protocol was registered on PROSPERO ( CRD42017077050 ) . Inclusion criteria were as follows : adults with early or chronic PD receiving treatment with injection therapy , penile traction , or a vacuum device .  EVIDENCE SYNTHESIS Fifty-two articles were selected according to the inclusion criteria -17 comparative studies and 35 cohort studies -analysing the effects of calcium channel blockers ( verapamil , nicardipine ) , collagenase Clostridium histolyticum ( CCH ) , interferon α-2b ( IFNα-2b ) , hyaluronic acid ( HA ) , onabotulinum toxin A , thiocolchicine , penile extender devices , and vacuum devices . Qualitative data from these studies suggest a clinical ly significant effect of CCH and IFNα-2b injection therapy to decrease penile curvature and conserve penile length . Verapamil and HA performed well in single-arm or case-control studies . Studies of penile traction and vacuum devices in patients with PD demonstrated some benefits in terms of curvature and penile length but only in small , underpowered , nonr and omised studies . Studies of onabotulinum toxin A injections or thiocolchicine showed significant improvements in penile curvature , but only in studies of single-arm or case-control design . CONCLUSIONS CCH and IFNα-2b injected into stable PD plaques can decrease penile curvature ; CCH can also improve penile length . However , based on available data , strong conclusions can not be drawn for other treatments , including calcium channel blockers , HA , or mechanical therapies . PATIENT SUMMARY Our systematic review of injection therapies provides evidence for improvements in penile curvature for patients with Peyronie 's disease . No robust evidence is available to support the use of other local treatments including calcium channel blockers , hyaluronic acid , or mechanical therapies
target: This method ological choice confers to the results a strong clinical relevance as PC has been reported to be one of the major determinants of bother and psychological distress in PD patients [ 2 ] .
  Initially , the results in terms of PC were disappointing , probably due to the inadequate dosage and regimen of the drug , or simply because of wrong
background: In this month 's issue of European Urology , Russo et al. [ 1 ] published the results of a systematic review of the literature about the efficacy of injection therapies , vacuum devices , and penile traction in patients with Peyronie 's disease ( PD ) .
  Historically , oral and intralesional therapies have represented the initial conservative option with surgery being considered the definitive gold st and ard therapy in stable disease .
  More recently , recommended treatment algorithms have significantly shifted due to the introduction of potential new first-line options .
  In this scenario , oral treatments have become less commonly prescribed due to inconsistent or negative outcome data , and intralesional therapies have gained growing interest .