A randomised trial of open versus laparoscopic colposuspension for genuine stress incontinence
| ISRCTN | ISRCTN14969683 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14969683 |
| Secondary identifying numbers | G9721060 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 18/07/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Henry C Kitchener
Scientific
Scientific
Academic Unit of Obstetrics & Gynaecology Reproductive Healthcare
University of Manchester
St Mary's Hospital
Whitworth Park
Manchester
M13 0JH
United Kingdom
| Phone | +44 (0)161 276 6646 |
|---|---|
| henry.kitchener@cmmc.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | MRC COLPO Trial |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Stress incontinence |
| Intervention | The interventions under study will be open or laparoscopic colposuspension. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/03/1999 |
| Completion date | 28/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 290 |
| Key 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. |
| Key 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.) |
| Date of first enrolment | 01/03/1999 |
| Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Unit of Obstetrics & Gynaecology Reproductive Healthcare
Manchester
M13 0JH
United Kingdom
M13 0JH
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results: | 01/09/2006 | Yes | No |
