Contact information
Type
Scientific
Primary contact
Mr Sudhanshu Chitale
ORCID ID
Contact details
Department of Urology
Norfolk and Norwich University Hospital NHS Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom
+44 (0) 1603 286776
sudhanshu.chitale@nnuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0547145275
Study information
Scientific title
Prospective randomised controlled double-blind trial of shock wave therapy (SWT) vs observation only (sham therapy) for Peyronie's disease
Acronym
Study hypothesis
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
Norfolk Research and Ethics Committee, 19/08/2004, ref: 04/Q0101/46
Study design
Double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/01/2005
Overall trial end date
12/12/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
40-60 in each arm
Participant 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)
Recruitment start date
01/01/2005
Recruitment end date
12/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Urology
Norwich
NR4 7UY
United Kingdom
Sponsor information
Organisation
Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Sponsor details
Colney Lane
Norwich
NR4 7UY
United Kingdom
+44 (0) 1603 286776
sudhanshu.chitale@nnuh.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Focus Medical Services (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20438568
Publication citations
-
Results
Chitale S, Morsey M, Swift L, Sethia K, Limited shock wave therapy vs sham treatment in men with Peyronie's disease: results of a prospective randomized controlled double-blind trial., BJU Int., 2010, 106, 9, 1352-1356, doi: 10.1111/j.1464-410X.2010.09331.x.