A randomised trial of transvaginal tape (TVT) versus transvaginal obturator tape (TVTO): a pilot study
ISRCTN | ISRCTN86612493 |
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DOI | https://doi.org/10.1186/ISRCTN86612493 |
Secondary identifying numbers | 04/0091 |
- Submission date
- 09/08/2010
- Registration date
- 21/10/2010
- Last edited
- 06/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Alison Sambrook
Scientific
Scientific
Department of Obstetrics & Gynaecology
Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom
Study information
Study design | Pilot single centre un-blinded randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 |
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(s) | Grampian Research Ethics Committee, 28/05/2004, ref: 04/0091 |
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 |
Primary outcome measure | 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 study start date | 01/08/2004 |
Overall study end date | 31/01/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 40 women |
Participant inclusion criteria | 1. Women aged over 18 years 2. Urodynamic stress incontinence 3. Failed conservative treatment 4. Being offered surgery |
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
- Scotland
- United Kingdom
Study participating centre
Department of Obstetrics & Gynaecology
Aberdeen
AB25 2ZN
United Kingdom
AB25 2ZN
United Kingdom
Sponsor information
University of Aberdeen
University/education
University/education
University Medical School
Foresterhill
Aberdeen
AB25 2ZD
Scotland
United Kingdom
p.hannaford@abdn.ac.uk | |
Website | http://www.abdn.ac.uk/ |
https://ror.org/016476m91 |
Funders
Funder type
University/education
University of Aberdeen
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- ABDN
- Location
- United Kingdom
NHS Grampian
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Basic results | 06/12/2019 | No | No |
Additional files
- ISRCTN86612493_Basic Results_2006.pdf
- uploaded 06/12/2019
Editorial Notes
06/12/2019: The basic results of this trial have been uploaded as an additional file.
23/09/2016: No publications found, verifying study status with principal investigator