Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence

Brno University Hospital

Status: Completed

Conditions: Urinary Incontinence, Stress

Treatments: Device: SIS - Innovative fixation single incision sling; Device: TOT - inside-out trans-obturator tape/sling

Study type: Interventional

Funder types: Other

Identifiers

NCT02506309

BrnoUH

Details and patient eligibility

About

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.

Full 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 2015 thru December 2015. 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 80 patients was required for each group.

Enrollment: 168 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

SIS single incision sling

Experimental group

Description:

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).

Treatment:

Device: SIS - Innovative fixation single incision sling

TOT trans obturator tape/sling

Active Comparator group

Description:

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).

Treatment:

Device: TOT - inside-out trans-obturator tape/sling