Contact information
Type
Scientific
Primary contact
Prof Henry C Kitchener
ORCID ID
Contact details
Academic Unit of Obstetrics & Gynaecology Reproductive Healthcare
University of Manchester
St Mary's Hospital
Whitworth Park
Manchester
M13 0JH
United Kingdom
+44 (0)161 276 6646
henry.kitchener@cmmc.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9721060
Study information
Scientific title
Acronym
MRC COLPO Trial
Study hypothesis
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.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Stress incontinence
Intervention
The interventions under study will be open or laparoscopic colposuspension.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/1999
Overall trial end date
28/02/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
290
Participant exclusion criteria
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.)
Recruitment start date
01/03/1999
Recruitment end date
28/02/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Unit of Obstetrics & Gynaecology Reproductive Healthcare
Manchester
M13 0JH
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
-
Results
Kitchener HC, Dunn G, Lawton V, Reid F, Nelson L, Smith AR, , Laparoscopic versus open colposuspension--results of a prospective randomised controlled trial., BJOG, 2006, 113, 9, 1007-1013, doi: 10.1111/j.1471-0528.2006.01035.x.