Randomised controlled trial of transvaginal tension-free vaginal tape-obturator (TVT-O) versus Monarc in treatment of urodynamic stress incontinence
| ISRCTN | ISRCTN71562338 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71562338 |
| Protocol serial number | 05/Q1104/176 |
| Sponsor | Countess of Chester NHS Foundation Trust (UK) |
| Funder | Any expenses incurred will be covered by Gynecare and American Medical Systems who produce the two tapes |
- Submission date
- 28/01/2006
- Registration date
- 16/03/2006
- Last edited
- 10/07/2017
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alison Peattie
Scientific
Scientific
Countess of Chester Hospital
Liverpool Road
Chester
CH2 1UL
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Randomised controlled trial of transvaginal tension-free vaginal tape-obturator (TVT-O) versus Monarc in treatment of urodynamic stress incontinence |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Objective and subjective cure of urodynamic stress incontinence |
| Key secondary outcome measure(s) |
1. Operating time |
| Completion date | 31/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 320 |
| Key inclusion criteria | 1. Females having a primary continence procedure without other surgery 2. Diagnosis of USI 3. Completed course of physiotherapy 4. Completed family |
| Key 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 |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 31/03/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Countess of Chester Hospital
Chester
CH2 1UL
United Kingdom
CH2 1UL
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/07/2017: No publications found, verifying study status with principal investigator.
