Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2010/EC/23, EC 2003/23
Study information
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
Acronym
TVT-O versus mini TVT-O
Study hypothesis
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
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)
Study design
Randomised two arm single blind controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below, to request a patient information sheet.
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/01/2007
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Female
Target number of participants
168 (84 patients per arm)
Participant 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
Recruitment start date
01/01/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Belgium
Trial participating centre
Service d'Urologie
LIEGE
B-4000
Belgium
Sponsor information
Organisation
University Hospital of Sart Tilman (CHU de Sart Tilman) (Belgium)
Sponsor details
Urology Department
Avenue de l'hopital 1
Bloc Central
Batiment B35
CHU Sart Tilman
LIEGE
4000
Belgium
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital of Liège (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list