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
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 to request a patient information sheet
Condition
Urodynamic Stress Incontinence (USI)
Intervention
Randomised controlled trial, patient allocation by random numbers with blocking
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
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