FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27445852
Enrollment
Unknown
Registered
2003-09-12
Start date
2001-09-01
Completion date
Unknown
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery: Gynaecological Surgery Gynaecological

Interventions

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

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: All patients undergoing surgery for urine incontinence or extensive pelvic surgery requiring catheterisation.

Exclusion criteria

Exclusion criteria: 1. Lower abdominal scar 2. Bladder tumour 3. Allergy to natural rubber latex 4. Patient does not wish to participate

Design outcomes

Primary

MeasureTime frame
The primary endpoint will be patient acceptability.—

Secondary

MeasureTime frame
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.—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026