Shock wave therapy (SWT) vs observation only (sham therapy) for Peyronie's disease

Completed

• Conditions: Peyronie's disease; Urological and Genital Diseases; Other disorders of penis

• Registration Number: ISRCTN64319581
• Lead Sponsor: orfolk and Norwich University Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

Current inclusion criteria as of 19/08/2008:
1. Penile deformity secondary to Peyronie's disease affecting ability to perform sexual intercourse and/or quality of life due to penile angulation
2. Age >18

Previous inclusion criteria:
1. 40-60 in each arm
2. Patients with suspected Peyronie's disease

Exclusion Criteria

Current exclusion criteria as of 19/08/2008:
1. Congenital curvature of the penis
2. Previous treatment for Peyronie's disease
3. Patients on warfarin

Previous exclusion criteria:
1. Patients on warfarin
2. Patients with total erectile dysfunction (ED)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 19/08/2008: <br>1. Mean change in angle of deformity for each arm of the study<br>2. Difference in mean change in angle between treatment and non-treatment arm<br>3. Difference in the mean International Index of Erectile Function (IIEF) scores pre and post treatment in each group <br><br>All primary and secondary outcomes were measured at 6 months post-therapy.<br><br>Previous primary outcome measure:<br>Reduction in the angle of penile deformity

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 19/08/2008: <br>The difference in pain scores measured by a visual analogue scale (VAS) and Global Assessment Questionnaire (GAQ) scores between two groups <br><br>All primary and secondary outcomes were measured at 6 months post-therapy.<br><br>Previous secondary outcome measures: <br>Improvement in pain scores (VAS) and erectile function scores (IIEF) and partner satisfaction