Proposal for pilot randomised controlled trial of pelvic floor exercises for premature ejaculation

ISRCTN	ISRCTN84594746
DOI	https://doi.org/10.1186/ISRCTN84594746
Protocol serial number	N0620154903
Sponsor	Department of Health
Funders	Exeter Primary Care Trust (UK), Own account, NHS R&D Support Funding

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

Dr Grace Dorey
Scientific

Old Hill Farm
Portmore
Barnstaple
EX32 0HR
United Kingdom

Primary study design	Interventional
Study design	Pilot randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	28/02/2007
Reason abandoned (if study stopped)	Lack of recruitment

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	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

Old Hill Farm

Barnstaple
EX32 0HR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan