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

Prospective randomised controlled double-blind trial of shock wave therapy (SWT) vs observation only (sham therapy) for Peyronie's disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64319581

Enrollment

120

Registered

2005-09-30

Start date

2005-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peyronie's disease Urological and Genital Diseases Other disorders of penis

Interventions

Six sessions of SWT over a period of 6 weeks at a rate of one session per week vs observation only (sham therapy).

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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)

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026