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

NCT02506309 | Completed Results

• 1 other identifier: BrnoUH
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Urinary Incontinence, Stress

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Negative Cough Stress Test (CST)

  Negative cough stress test four years after incontinence surgery.

  four years

• Patient Global Impression of Improvement (PGI-I) Score

  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 1. Very much better 2. Much better 3. A little better 4. No change 5. A little worse 6. Much worse 7. Very much worse

  four years

Secondary Outcomes (2)

• Number of Participants With Major Perioperative Complications

  one month

• Number of Participants With Major Postoperative Complications

  four years

Study Arms (2)

SIS single incision sling

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).

Device: SIS - Innovative fixation single incision sling

TOT trans obturator tape/sling

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).

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

Interventions

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)

Also known as: Gynecare TVT Obturator System (Ethicon)

TOT trans obturator tape/sling

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)

Also known as: Ophira (Promedon)

SIS single incision sling

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brno University Hospital: lead

Related Publications (4)

• Ogah J, Cody DJ, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women: a short version Cochrane review. Neurourol Urodyn. 2011 Mar;30(3):284-91. doi: 10.1002/nau.20980.

  PMID: 21412819 BACKGROUND

• Nambiar A, Cody JD, Jeffery ST. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2014 Jun 1;(6):CD008709. doi: 10.1002/14651858.CD008709.pub2.

  PMID: 24880654 BACKGROUND

• Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

  PMID: 37888839 DERIVED

• Huser M, Hudecek R, Belkov I, Horvath I, Jarkovsky J, Tvarozek S. Safety and Efficacy of Single Incision Sling Versus Midurethral Sling in the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial. Urogynecology (Phila). 2023 Feb 1;29(2):113-120. doi: 10.1097/SPV.0000000000001284.

  PMID: 36735422 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: dr. Martin Huser
• Organization: Brno University Hospital

huser.martin@fnbrno.cz

+420532233843

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 23, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2019
• Last Updated: February 18, 2020
• Results First Posted: June 5, 2017

Record last verified: 2020-02