Use of Penile Extender Device in the Treatment of Penile Curvature as a Result of Peyronie’s Disease. Results of a Phase II Prospective Study
- 1 February 2009
- journal article
- Published by Oxford University Press (OUP) in The Journal of Sexual Medicine
- Vol. 6 (2), 558-566
- https://doi.org/10.1111/j.1743-6109.2008.01108.x
Abstract
Pilot experiences have suggested that tension forces exerted by a penile extender may reduce penile curvature as a result of Peyronie's disease. To test this hypothesis in a Phase II study using a commonly marketed brand of penile extender. Peyronie's disease patients with a curvature not exceeding 50° with mild or no erectile dysfunction (ED) were eligible. Fifteen patients were required to test the efficacy of the device assuming an effect size of >0.8, consistent with an “important” reduction in penile curvature. Changes in penile length over baseline and erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) constituted secondary end points. Patients were counselled on the use of the penile extender for at least 5 hours per day for 6 months. Photographic pictures of the erect penis and measurements were carried out at baseline, at 1, 3, 6, and 12 months (end of study). The IIEF-EF domain scores were administered at baseline and at the end of study. Treatment satisfaction was assessed at end of study using a nonvalidated institutional 5-item questionnaire. Penile curvature decreased from an average of 31° to 27° at 6 months without reaching the effect size (P = 0.056). Mean stretched and flaccid penile length increased by 1.3 and 0.83 cm, respectively at 6 months. Results were maintained at 12 months. Overall treatment results were subjectively scored as acceptable in spite of curvature improvements, which varied from “no change” to “mild improvement.” In our study, the use of a penile extender device provided only minimal improvements in penile curvature but a reasonable level of patient satisfaction, probably attributable to increased penile length. The selection of patients with a stabilized disease, a penile curvature not exceeding 50°, and no severe ED may have led to outcomes underestimating the potential efficacy of the treatment. Gontero P, Di Marco M, Giubilei G, Bartoletti R, Pappagallo G, Tizzani A, and Mondaini N. Use of penile extender device in the treatment of penile curvature as a result of Peyronie's disease. Results of a phase II prospective study. J Sex Med 2009;6:558–566.This publication has 17 references indexed in Scilit:
- Risk Factors for Emotional and Relationship Problems in Peyronie's DiseaseThe Journal of Sexual Medicine, 2008
- Impact of Peyronie's Disease on Sexual and Psychosocial Functioning: Qualitative Findings in Patients and ControlsThe Journal of Sexual Medicine, 2008
- Penile Traction Therapy for Treatment of Peyronie's Disease: A Single-Center Pilot StudyThe Journal of Sexual Medicine, 2008
- Continuing Medical Education: Peyronie's Disease (CME)The Journal of Sexual Medicine, 2007
- Systematic Evidence-Based Analysis of Plaque Injection Therapy for Peyronie's DiseaseEuropean Urology, 2007
- Critical analysis of surgery for Peyronieʼs diseaseCurrent Opinion in Urology, 2004
- 1256: Five Year Followup of Plaque Incision and Vein Grafting for Peyronie's DiseaseJournal of Urology, 2004
- Peyronie??s disease: a reviewCurrent Opinion in Urology, 2003
- Diagnostic evaluation of the erectile function domain of the international index of erectile functionUrology, 1999
- The Natural History of Peyronie’s DiseaseJournal of Urology, 1990