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ISRCTN
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ISRCTN14969683
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DOI
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10.1186/ISRCTN14969683
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised trial of open versus laparoscopic colposuspension for genuine stress incontinence
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Scientific title
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Acronym
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MRC COLPO Trial
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Serial number at source
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G9721060
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Study hypothesis
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To compare the cure rates in the two intervention groups. Additionally the two procedures will be compared in terms of perioperative morbidity, recovery time, incidence of postoperative voiding dysfunction, de novo detrusor instability and health economic costs to NHS and patient.
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stress incontinence
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Participants - inclusion criteria
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1. Any woman for whom a decision has been made to perform a colposuspension for cystometrically proven genuine stress incontinence.
2. Women who have had an anterior colporrhaphy would be eligible as it is considered that their inclusion is pragmatic reflecting everyday practice.
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Participants - exclusion criteria
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1. Women in whom bladder neck surgery is contraindicated;
2. Women with detrusor instability.
3. Women who have had previous retropubic bladder neck surgery (colposuspension or sling procedure) or sacrocolpopexy.
4. Women who are unhappy to be randomised to laparoscopic colposuspension.
5. Women considered too obese for open colposuspension. (Laparoscopic colposuspension is only to be available as part of the trial.)
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Anticipated start date
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01/03/1999
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Anticipated end date
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28/02/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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290
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Interventions
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The interventions under study will be open or laparoscopic colposuspension.
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Primary outcome measure(s)
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Primary Outcomes: complete cure of stress incontinence at 24 and 48 months. Symptom improvement classified as: Complete (have never leaked since surgery and no leakage objectively demonstrated),
Acceptable Improvement (matched patient expectations), Inadequate Improvement, No improvement, Worse. Levels of significant operative morbidity.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16956332
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Contact name
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Prof
Henry C
Kitchener
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Address
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Academic Unit of Obstetrics & Gynaecology Reproductive Healthcare
University of Manchester
St Mary's Hospital
Whitworth Park
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City/town
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Manchester
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Zip/Postcode
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M13 0JH
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Country
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United Kingdom
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Tel
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+44 (0)161 276 6646
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Fax
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+44 (0)161 276 6134
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Email
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henry.kitchener@cmmc.nhs.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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18/07/2007
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Date ISRCTN assigned
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25/10/2000
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