Condition category
Urological and Genital Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
25/09/2013
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

Dr Karen Boyd

ORCID ID

Contact details

Yorkshire Health
Department of Obstetrics and Gynaecology
Belmont Grove
Leeds
Leeds
LS2 9NS
United Kingdom
+44 (0)113432799

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

F0004

Study information

Scientific title

Acronym

Study hypothesis

A Colposuspension procedure is one of the most effective operations undertaken to cure female urinary incontinence. Some gynaecologists believe that a laparoscopically performed Colposuspension may be superior to traditional open Colposuspension in terms of recovery time and cost effectiveness. However, there has never been a formal evaluation of the new procedure and the additional equipment costs and additional operative time required for a laparoscopic approach have never been justified. We plan to assess the value of laparoscopic Colposuspension in a prospective randomised controlled trial. We also aim to assess the value of day ward post-operative care in of catheterised patients in a randomised controlled trial since the benefits of shorter recovery time for the laparoscopic procedure would have little effect if patients were still required to stay in hospital catheterised until normal voiding was resumed.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Incontinence

Intervention

Laparoscopically performed Colposuspension vs. open Colposuspension procedure

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Assessment of outpatient or day ward post-operative care will include
1.1. Urinary tract infection rates
1.2. Rates of catheter problems such as kinking or blocking
1.3. Patient satisfaction.
2. The outcome variables of interest are
2.1. Surgical success rates
2.2. Infection rates
2.3. Intra-operative blood loss
2.4. Post-operative pyrexia
2.5. Length of stay
2.6. Estimated financial costings

Secondary outcome measures

Not provided at time of registration

Overall trial start date

03/01/1994

Overall trial end date

28/02/1996

Reason abandoned

Eligibility

Participant inclusion criteria

Women with urinary incontinence

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

03/01/1994

Recruitment end date

28/02/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Yorkshire Health
Leeds
LS2 9NS
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Additional files

Editorial Notes