Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0158108047

Study information

Scientific title

Acronym

Study hypothesis

To identify the most acceptable method of suprapubic catheterisation after colposuspension.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2001

Overall trial end date

01/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Not Specified

Gender

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

United Kingdom

Trial 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

http://www.doh.gov.uk

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes