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Proposal for pilot randomised controlled trial of pelvic floor exercises for premature ejaculation
ISRCTN ISRCTN84594746
ClinicalTrials.gov identifier
Public title Proposal for pilot randomised controlled trial of pelvic floor exercises for premature ejaculation
Scientific title
Acronym N/A
Serial number at source N0620154903
Study hypothesis Exploring the effectiveness of pelvic floor exercises for premature ejaculation.
Lay summary
Ethics approval Not provided at time of registration
Study design Pilot randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Mental and Behavioural Disorders: Premature ejaculation (PE)
Participants - inclusion criteria Not provided at time of registration
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 18/10/2004
Anticipated end date 28/02/2007
Status of trial Stopped
Patient information material
Target number of participants 15 men in each arm of the trial, total 30
Interventions 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.
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.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Exeter Primary Care Trust (UK)
Own account
NHS R&D Support Funding
Trial website
Publications
Contact name Dr  Grace  Dorey
  Address Old Hill Farm
Portmore

  City/town Barnstaple
  Zip/Postcode EX32 0HR
  Country United Kingdom
Sponsor Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Fax +44 (0)20 7307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2005
Last edited 31/03/2011
Date ISRCTN assigned 30/09/2005
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