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 |
| Protocol serial number | 9452 |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Funder | University Hospitals of Leicester NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) | 1. Objective cure rate (24 hour pad test) 2. Subjective cure rate (Leakage on 3 day voiding dairy) |
| Key secondary outcome measure(s) | 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]) |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Directorate of Women's, Perinatal & Sexual Health
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
