Proposal for pilot randomised controlled trial of pelvic floor exercises for premature ejaculation
| ISRCTN | ISRCTN84594746 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84594746 |
| Secondary identifying numbers | N0620154903 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 31/03/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Grace Dorey
Scientific
Scientific
Old Hill Farm
Portmore
Barnstaple
EX32 0HR
United Kingdom
Study information
| Study design | Pilot randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Exploring the effectiveness of pelvic floor exercises for premature ejaculation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Premature ejaculation (PE) |
| Intervention | Treatment group of men with premature ejaculation (PE) receiving pelvic floor exercises and relaxation advice and a non-treatment control group of men with PE receiving only relaxation advice. |
| Intervention type | Other |
| Primary outcome measure | 1. Subjects in both groups to be evaluated for PE initially, and at 3 months by completing a questionnaire. 2. Subjective & objective physiotherapy assessment to include digital anal measurements by clinician. 3. Assessment by Ros Wills, a physiotherapist who is blinded to the subject grouping. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 18/10/2004 |
| Completion date | 28/02/2007 |
| Reason abandoned (if study stopped) | Lack of recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 15 men in each arm of the trial, total 30 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 18/10/2004 |
| Date of final enrolment | 28/02/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Old Hill Farm
Barnstaple
EX32 0HR
United Kingdom
EX32 0HR
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Exeter Primary Care Trust (UK)
No information available
Own account
No information available
NHS R&D Support Funding
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 |
