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

Not Applicable

Completed

• Conditions: Surgery: Gynaecological; Surgery; Gynaecological

• Registration Number: ISRCTN27445852
• Lead Sponsor: Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2003-09-01
• Study Start: 2003-09-12
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be patient acceptability.

Secondary Outcome Measures

Name	Time	Method
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.