Overview

This trial is active, not recruiting.

Condition urinary incontinence, stress
Treatments tot - inside-out trans-obturator tape/sling, sis - innovative fixation single incision sling
Sponsor Brno University Hospital
Start date January 2012
End date December 2014
Trial size 93 participants
Trial identifier NCT02506309, BrnoUH

Summary

Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. A third generation of the MUS inserted through a single vaginal incision (SIS) has become a means to overcome significant post-operative groin pain. Novel types of SIS with a more robust and adjustable anchoring mechanism can assure adequate long-lasting attachment to the obturator membrane (OM). Objective of this study was to compare an inside-out TOT with an innovative fixation SIS in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).
sis - innovative fixation single incision sling Ophira (Promedon)
Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)
(Active Comparator)
TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).
tot - inside-out trans-obturator tape/sling Gynecare TVT Obturator System (Ethicon)
Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)

Primary Outcomes

Measure
Negative cough stress test (CST)
time frame: one year
Negative cough stress test (CST)
time frame: two years
Negative cough stress test (CST)
time frame: five years

Secondary Outcomes

Measure
Patient Global Impression of Improvement (PGI-I) score
time frame: one year
Patient Global Impression of Improvement (PGI-I) score
time frame: two years
Patient Global Impression of Improvement (PGI-I) score
time frame: five years

Eligibility Criteria

Female participants at least 35 years old.

Inclusion Criteria: Women with pure or predominant urodynamic stress urinary incontinence confirmed during filling cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position. Exclusion Criteria: - patients with predominant urge incontinence - patients with intrinsic sphincter deficiency (MUCP<20 cmH2O) - pelvic organ prolapse (POP-Q>2) - previous urinary incontinence surgery - previous pelvic organ prolapse surgery - presence of other pelvic organ pathology.

Additional Information

Official title Prospective Randomized Comparison of the Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence
Description Objective of this study was to compare an inside-out TOT (Gynecare TVT Obturator System, Ethicon) with an innovative fixation SIS (Ophira, Promedon) in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI. A prospective randomized controlled trial (RCT) is performed in one tertiary referral urogynecology center from January 2012 thru December 2013. Study included women with pure or predominant urodynamic SUI confirmed during cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position. Study was carried out on a Caucasian Czech (central European) population. A study power analysis was calculated with an expected objective cure rate of minimum 80 % for both patient groups, false non-match rate (alpha) of 0.05, and false match rate (beta) of 0.10. A minimum sample size of 42 patients was required for each group.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Brno University Hospital.