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NCT Number: NCT02506309

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

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.

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Key information

Conditions

Urinary Incontinence, Stress Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TOT - inside-out trans-obturator tape/sling

Device

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)

Other names: Gynecare TVT Obturator System (Ethicon)

SIS - Innovative fixation single incision sling

Device

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)

Other names: Ophira (Promedon)

Primary outcomes

  1. Percentage of Participants With Negative Cough Stress Test (CST)

    Time frame: four years

    Negative cough stress test four years after incontinence surgery.

  2. Patient Global Impression of Improvement (PGI-I) Score

    Time frame: four years

    Patient Global Impression of Improvement (PGI-I) score four years after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians

    • Very much better
    • Much better
    • A little better
    • No change
    • A little worse
    • Much worse
    • Very much worse

Secondary outcomes

  1. Number of Participants With Major Perioperative Complications

    Time frame: one month

  2. Number of Participants With Major Postoperative Complications

    Time frame: four years

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2019
First posted
Jul 23, 2015
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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