Contact information
Type
Scientific
Contact name
Mr J Cooper
ORCID ID
Contact details
MO33
NSPD
Women's and Children's Division
North Staffordshire Hospital (NHS) Trust
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
+44 (0)1782 552737
a@b.c
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0158108047
Study information
Scientific title
Prospective randomised controlled trial of the usability and complications of two devices for suprapubic catheterisation in gynaecological surgery (TOSCA)
Acronym
Study hypothesis
To identify the most acceptable method of suprapubic catheterisation after colposuspension.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
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
Overall study end date
01/09/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients undergoing surgery for urine incontinence or extensive pelvic surgery requiring catheterisation.
Participant type(s)
Patient
Age group
Not Specified
Sex
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Lower abdominal scar
2. Bladder tumour
3. Allergy to natural rubber latex
4. Patient does not wish to participate
Recruitment start date
01/09/2001
Recruitment end date
01/09/2003
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
MO33
Stoke-on-Trent
ST4 6QG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Staffordshire Research and Development Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|