Condition category
Urological and Genital Diseases
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
18/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16956332

Publication citations

  1. 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.

Additional files

Editorial Notes