Condition category
Urological and Genital Diseases
Date applied
07/02/2010
Date assigned
26/03/2010
Last edited
04/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Waltregny

ORCID ID

Contact details

Service d'Urologie
Bloc Central
Batiment B35 -1
Centre Hospitalier Universitaire (CHU) de Sart Tilman
LIEGE
B-4000
Belgium

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 measures

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

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

http://www.chuliege.be/sm/71.html

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes