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

• Register: ISRCTN
• Last refreshed on: 6 January 2020
• Main ID: ISRCTN27445852
• Date of registration: 12/09/2003
• Prospective Registration: No
• Primary sponsor: Department of Health (UK)
• Public title: Prospective randomised controlled trial of the usability and complications of two devices for suprapubic catheterisation in gynaecological surgery (TOSCA)
• Scientific title: Prospective randomised controlled trial of the usability and complications of two devices for suprapubic catheterisation in gynaecological surgery (TOSCA)
• Date of first enrolment: 01/09/2001
• Target sample size: 0
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN27445852
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: J Cooper

Key inclusion & exclusion criteria

Inclusion criteria: All patients undergoing surgery for urine incontinence or extensive pelvic surgery requiring catheterisation.
Exclusion criteria:
1. Lower abdominal scar
2. Bladder tumour
3. Allergy to natural rubber latex
4. Patient does not wish to participate


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Surgery: Gynaecological
Surgery
Gynaecological

Intervention(s)

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]).

Primary Outcome(s)

The primary endpoint will be patient acceptability.

Secondary Outcome(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.

Secondary ID(s)

N0158108047

Source(s) of Monetary Support

North Staffordshire Research and Development Consortium (UK)

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration

Results

• Results available: Yes
• Date Completed: 01/09/2003