Randomised trial of tension-free vaginal tape and transobturator tape as treatment for urinary stress incontinence in women
| ISRCTN | ISRCTN34377436 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34377436 |
| Secondary identifying numbers | 9452 |
- Submission date
- 16/09/2005
- Registration date
- 11/11/2005
- Last edited
- 13/09/2013
- 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 of protocol
Not provided at time of registration
Contact information
Mr Christopher Mayne
Scientific
Scientific
Directorate of Women's, Perinatal & Sexual Health
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
| christopher.mayne@uhl-tr.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To compare the cure rate and complication rate of the tension-free vaginal tape (TVT) and tension free vaginal tape obturator (TVT-O) procedure (TVT & TVT-O, Gynecare, Somerville, New Jersey) |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urodynamic stress incontinence |
| Intervention | TVT versus TVT-O |
| Intervention type | Other |
| Primary outcome measure | 1. Objective cure rate (24 hour pad test) 2. Subjective cure rate (Leakage on 3 day voiding dairy) |
| Secondary outcome measures | 1. Change in quality of life (Kings Health Questionnaire [KHQ]) 2. Change in symptom severity (Bristol Female Lower Urinary Tract Symptom Questionnaire [BFLUTS], International Consultation on Incontinence questionnaire [ICIQ]) 3. Pre and postoperative complications 4. Pain at 1 hour and 1 week (Visual Analogue Scale [VAS]) |
| Overall study start date | 01/10/2004 |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Urodynamic stress incontinence 2. Primary continence procedure |
| Key exclusion criteria | 1. Detrusor overactivity 2. Voiding Dysfunction 3. Prolapse ≥ pelvic organ prolapse quantification system (POP-Q) stage 2 |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Directorate of Women's, Perinatal & Sexual Health
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development Directorate
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| nicola.turner@uhl-tr.nhs.uk | |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Government
University Hospitals of Leicester NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2011 | Yes | No |
