Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04/0091
Study information
Scientific title
A randomised controlled pilot study comparing transvaginal obturator tape (TVTO) to transvaginal tape (TVT) for the treatment of genuine stress incontinence in women
Acronym
Study hypothesis
To compare the effectiveness and costs of transvaginal tape (TVT) with transvaginal obturator tape (TVTO) and to use the data on health related quality of life as measured over the trial follow-up. This pilot study aimed to recruit 20 women to each treatment arm in order to enable a power calculation to be performed to establish the number of participants required for a definitive randomised controlled trial between the experimental and control treatment.
Ethics approval
Grampian Research Ethics Committee, 28/05/2004, ref: 04/0091
Study design
Pilot single centre un-blinded 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 below to request a patient information sheet
Condition
Stress urinary incontinence
Intervention
This is a pilot single centre un-blinded randomised controlled trial with a 12 month follow-up. Randomisation is independently prepared numbered opaque sealed envelopes stored independently from the trial office.
Patients will be randomised to one of the following:
1. Experimental treatment: transvaginal obturator tape (TVTO)
2. Control treatment: transvaginal tape (TVT)
Patients were consented on admission to hospital but had previously received verbal information and written information leaflet at the urodynamic clinic or via post and again on admission to the ward. Women were randomised to one of the two procedures once consent had been obtained. The two interventions were performed as described by the manufacturing company, Gynecare. The operating surgeons were experienced in both forms of surgery and the procedure was performed in an operating theatre under either spinal or general anaesthetic dependant on the patient choice. Women were discharged typically on the day of surgery but discharge was determined by the ability to void a normal amount of urine.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Changes in International Consultation on Incontinence Questionnaire (ICIQ), assessed at baseline
2. Differences in quality adjusted life years (QALYs) estimated from responses to the EQ-5D, measured at baseline and 12 months
Secondary outcome measures
1. Subjective cure rate
2. Changes in the King's Health questionnaire (KHQ) scores
3. Difference in EQ-5D scores at three and twelve months follow-up
4. Operative data
5. Self-reported acceptability
6. Usage recommendation to a friend
All measured at baseline, two weeks (except for the EQ-5D), three months and twelve months.
Overall trial start date
01/08/2004
Overall trial end date
31/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women aged over 18 years
2. Urodynamic stress incontinence
3. Failed conservative treatment
4. Being offered surgery
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
40 women
Participant exclusion criteria
1. Not prepared to accept surgery
2. Requiring additional prolapse surgery
3. Undergone previous surgery for stress urinary incontinence
4. Not completed their families, i.e., will still want children
5. Unable or unwilling to give informed consent
6. Unwilling to participate in follow-up
Recruitment start date
01/08/2004
Recruitment end date
31/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Obstetrics & Gynaecology
Aberdeen
AB25 2ZN
United Kingdom
Sponsor information
Organisation
University of Aberdeen
Sponsor details
University Medical School
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
-
p.hannaford@abdn.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Aberdeen
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Funder name
NHS Grampian
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