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

ISRCTN	ISRCTN64319581
DOI	https://doi.org/10.1186/ISRCTN64319581
Protocol serial number	N0547145275
Sponsor	Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Funders	Focus Medical Services (UK), Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)

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

Department of Urology
Norfolk and Norwich University Hospital NHS Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom

Phone	+44 (0) 1603 286776
Email	sudhanshu.chitale@nnuh.nhs.uk

Study information

Primary study design	Interventional
Study design	Double-blind randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	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
Completion date	12/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	120
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

United Kingdom
England

Study participating centre

Department of Urology

Norwich
NR4 7UY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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