Prospective randomised controlled trial of the usability and complications of two devices for suprapubic catheterisation in gynaecological surgery (TOSCA)

ISRCTN	ISRCTN27445852
DOI	https://doi.org/10.1186/ISRCTN27445852
Secondary identifying numbers	N0158108047

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 12/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

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

Mr J Cooper
Scientific

MO33
NSPD
Women's and Children's Division
North Staffordshire Hospital (NHS) Trust, Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Phone	+44 (0)1782 552737
Email	a@b.c

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Prospective randomised controlled trial of the usability and complications of two devices for suprapubic catheterisation in gynaecological surgery (TOSCA)
Study objectives	To identify the most acceptable method of suprapubic catheterisation after colposuspension.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Gynaecological
Intervention	All patients undergoing surgery for stress incontinence and extensive pelvic dissection which requires urinary catheterisation will be eligible to enter. Randomisation will be performed by a telephone link to a computer programme. Catheters will be inserted in theatre under general anaesthetic or spinal, irrespective of allocation. Procedures will be carried out by clinicians who have been trained in the insertion of both types of catheter. Data will be collected by questionnaire (three forms: one for the patient, one for the nursing staff, one for the surgeon[s]).
Intervention type	Device
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	The primary endpoint will be patient acceptability.
Secondary outcome measures	The secondary endpoint will be complication rates for each catheter, the ease of performance of catheterisation, including any complications reported by the surgeon, and the ease of management of patients (while on catheter) as reported by the nursing staff.
Overall study start date	01/09/2001
Completion date	01/09/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	Not provided at time of registration
Key inclusion criteria	All patients undergoing surgery for urine incontinence or extensive pelvic surgery requiring catheterisation.
Key exclusion criteria	1. Lower abdominal scar 2. Bladder tumour 3. Allergy to natural rubber latex 4. Patient does not wish to participate
Date of first enrolment	01/09/2001
Date of final enrolment	01/09/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

MO33

Stoke-on-Trent
ST4 6QG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

North Staffordshire Research and Development Consortium (UK)

No information available

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

Editorial Notes

12/12/2019: No publications found. All search options exhausted.