Laparoscopic treatment for female urinary incontinence

ISRCTN	ISRCTN44339585
DOI	https://doi.org/10.1186/ISRCTN44339585
Protocol serial number	F0004
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 24/10/2019

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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Karen Boyd
Scientific

Yorkshire Health
Department of Obstetrics and Gynaecology
Belmont Grove
Leeds
LS2 9NS
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Laparoscopic treatment for female urinary incontinence
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Incontinence
Intervention	Laparoscopically performed Colposuspension vs. open Colposuspension procedure
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	28/02/1996

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key inclusion criteria	Women with urinary incontinence
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	03/01/1994
Date of final enrolment	28/02/1996

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Yorkshire Health

Leeds
LS2 9NS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

24/10/2019: No publications found. All search options exhausted.