Condition category
Mental and Behavioural Disorders
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
31/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Grace Dorey

ORCID ID

Contact details

Old Hill Farm
Portmore
Barnstaple
EX32 0HR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0620154903

Study information

Scientific title

Acronym

Study hypothesis

Exploring the effectiveness of pelvic floor exercises for premature ejaculation.

Ethics approval

Not provided at time of registration

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

18/10/2004

Overall trial end date

28/02/2007

Reason abandoned

Lack of recruitment

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

15 men in each arm of the trial, total 30

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

18/10/2004

Recruitment end date

28/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Old Hill Farm
Barnstaple
EX32 0HR
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Exeter Primary Care Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own account

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

Publication citations

Additional files

Editorial Notes