Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
02/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nnuh.nhs.uk

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

  1. 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.

Additional files

Editorial Notes