Condition category
Urological and Genital Diseases
Date applied
28/01/2006
Date assigned
16/03/2006
Last edited
09/03/2015
Prospective/Retrospective
Prospectively 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

Dr Alison Peattie

ORCID ID

Contact details

Countess of Chester Hospital
Liverpool Road
Chester
CH2 1UL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05/Q1104/176

Study information

Scientific title

Randomised controlled trial of transvaginal tension-free vaginal tape-obturator (TVT-O) versus Monarc in treatment of urodynamic stress incontinence

Acronym

Study hypothesis

A comparison of two different ways of placing a suburethral tape (surgical procedure) to correct Urodynamic Stress Incontinence (USI). An assessment of the success rate and complications of the two procedures.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial, patient allocation by random numbers with blocking

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Urodynamic Stress Incontinence (USI)

Intervention

Surgery - either of two ways of placing a transobturator tape to correct the incontinence, tension-free vaginal tape-obturator (TVT-O) versus Monarc

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Objective and subjective cure of urodynamic stress incontinence

Secondary outcome measures

1. Operating time
2. Blood loss
3. Complications
4. Pain
5. Catheter use post-operatively
6. Voiding

Overall trial start date

01/04/2006

Overall trial end date

31/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Females having a primary continence procedure without other surgery
2. Diagnosis of USI
3. Completed course of physiotherapy
4. Completed family

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

320

Participant exclusion criteria

1. Previous continence or prolapse surgery
2. Neurological disease
3. Pregnancy
4. Urinary tract or vaginal infection
5. Detrusor overactivity
6. Voiding problem
7. Anticoagulant use

Recruitment start date

01/04/2006

Recruitment end date

31/03/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Countess of Chester Hospital
Chester
CH2 1UL
United Kingdom

Sponsor information

Organisation

Countess of Chester NHS Foundation Trust (UK)

Sponsor details

Liverpool Road
Chester
CH2 1UL
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Any expenses incurred will be covered by Gynecare and American Medical Systems who produce the two tapes

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