Shock wave therapy (SWT) vs observation only (sham therapy) for Peyronie's disease
| ISRCTN | ISRCTN64319581 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64319581 |
| Secondary identifying numbers | N0547145275 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 02/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Sudhanshu Chitale
Scientific
Scientific
Department of Urology
Norfolk and Norwich University Hospital NHS Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom
| Phone | +44 (0) 1603 286776 |
|---|---|
| sudhanshu.chitale@nnuh.nhs.uk |
Study information
| Study design | Double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Prospective randomised controlled double-blind trial of shock wave therapy (SWT) vs observation only (sham therapy) for Peyronie's disease |
| Study objectives | To confirm the question of efficacy of shock wave therapy (SWT) in patients randomised to the treatment arm and assess whether an active treatment such a SWT leads to statistically significant improvement in these patients compared to that achieved by natural resolution. On 19/08/2008 the following changes were made to the trial record: 1. The public trial title was changed from "Prospective Randomised Trial of Shock Wave Therapy vs Conservative Management of Peyronie's Disease" to "Shock wave therapy (SWT) vs observation only (sham therapy) for Peyronie's disease". 2. The scientific title was added. 3. The anticipated start date was changed from 01/04/2004 to 01/01/2005. 4. The anticipated end date was changed from 31/03/2006 to 12/12/2006. 5. The sources of funding field was updated. Previous sources of funding: 1. East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT 2. NHS R&D Support Funding |
| Ethics approval(s) | Norfolk Research and Ethics Committee, 19/08/2004, ref: 04/Q0101/46 |
| Health condition(s) or problem(s) studied | Peyronie's disease |
| Intervention | Six sessions of SWT over a period of 6 weeks at a rate of one session per week vs observation only (sham therapy). |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/01/2005 |
| Completion date | 12/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 40-60 in each arm |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 12/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Urology
Norwich
NR4 7UY
United Kingdom
NR4 7UY
United Kingdom
Sponsor information
Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Colney Lane
Norwich
NR4 7UY
England
United Kingdom
| Phone | +44 (0) 1603 286776 |
|---|---|
| sudhanshu.chitale@nnuh.nhs.uk | |
| Website | http://www.nnuh.nhs.uk |
"ROR" |
https://ror.org/01wspv808 |
Funders
Funder type
Government
Focus Medical Services (UK)
No information available
Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2010 | Yes | No |
