Comparison between the two transobturator inside-out procedures for the surgical treatment of female stress urinary incontinence: A randomised clinical trial
| ISRCTN | ISRCTN65635093 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65635093 |
| Secondary identifying numbers | 2010/EC/23, EC 2003/23 |
- Submission date
- 07/02/2010
- Registration date
- 26/03/2010
- Last edited
- 04/10/2011
- 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
Prof David Waltregny
Scientific
Scientific
Service d'Urologie
Bloc Central
Batiment B35 -1
Centre Hospitalier Universitaire (CHU) de Sart Tilman
LIEGE
B-4000
Belgium
Study information
| Study design | Randomised two arm single blind controlled parallel group trial |
|---|---|
| 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 contact details below, to request a patient information sheet. |
| Scientific title | Clincial comparison between the original TVT-O and a modified procedure (mini TVT-O) for the surgical treatment of female stress urinary incontinence: A randomised clinical trial with 1-year follow-up |
| Study acronym | TVT-O versus mini TVT-O |
| Study objectives | A shorter transobturator tape placed inside-out with minimized dissection would result in similar cure rates as those obtained with the original inside-out transobturator procedure, but may result in less post-operative pain and complications. |
| Ethics approval(s) | The Ethics Committee of University Hospital of Liege (Comité d'Ethique Hospitalo-Universitaire de Liège) approved on the 10th of October 2006 (ref: amendment #3 to EC approval # 2003/23) |
| Health condition(s) or problem(s) studied | Female stress urinary incontinence |
| Intervention | Surgical treatment: original inside-out transobturator tape (TVT-O™) versus a modification of the procedure, with no perforation of the obturator membrane and a shorter tape length. The procedure lasts approx 15 minutes. The total duration of follow up is 12 months |
| Intervention type | Other |
| Primary outcome measure | 1. Objective and subjective cure of stress urinary incontinence at 1 year, measured by 1.1. Cough test (objective cure) 1.2. Measurement of Urinary Handicap (MUH), a validated self-administered questionnaire 2. Complication rates during a 1-year follow-up period, assessed by clinical examination and patient reporting at visits |
| Secondary outcome measures | Incidence and severity of postoperative pain at baseline, 1 day, 1, 6 and 12 months, measured by Visual Analogue Score (VAS) - inner thigh pain assessed for each side, left and right |
| Overall study start date | 01/01/2007 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Female |
| Target number of participants | 168 (84 patients per arm) |
| Key inclusion criteria | 1. Age between 25 and 85 years 2. Clinical and urodynamic diagnoses of Stress Urinary Incontinence (SUI) 3. Positive stress test 4. Maximum cystometric capacity 300 ml or greater |
| Key exclusion criteria | 1. Urodynamically proven detrusor overactivity 2. Impaired bladder contractility 3. Post void residual (PVR) 100 ml or greater 4. Contraindication to anaesthesia 5. Pregnancy 6. Neurogenic bladder 7. Active urinary or vaginal infection 8. Concomitant symptomatic and/or significant (more than second degree) pelvic organ prolapse (POP) 9. Patient not willing or unable to participate in the trial |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Service d'Urologie
LIEGE
B-4000
Belgium
B-4000
Belgium
Sponsor information
University Hospital of Sart Tilman (CHU de Sart Tilman) (Belgium)
Hospital/treatment centre
Hospital/treatment centre
Urology Department
Avenue de l'hopital 1
Bloc Central
Batiment B35
CHU Sart Tilman
LIEGE
4000
Belgium
| Website | http://www.chuliege.be/sm/71.html |
|---|---|
"ROR" |
https://ror.org/044s61914 |
Funders
Funder type
Hospital/treatment centre
University Hospital of Liège (Belgium)
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 |
