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 |
| Protocol serial number | N0158108047 |
| Sponsor | Department of Health (UK) |
| Funder | North Staffordshire Research and Development Consortium (UK) |
- 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
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 |
|---|---|
| a@b.c |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
The primary endpoint will be patient acceptability. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| 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
- United Kingdom
- England
Study participating centre
MO33
Stoke-on-Trent
ST4 6QG
United Kingdom
ST4 6QG
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
12/12/2019: No publications found. All search options exhausted.
