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

NCT ID: NCT02506309

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-12-31

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.

Detailed 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.

Conditions

Urinary Incontinence, Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SIS single incision sling

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).

Group Type: EXPERIMENTAL

SIS - Innovative fixation single incision sling

Intervention Type: 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)

TOT trans obturator tape/sling

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).

Group Type: ACTIVE_COMPARATOR

TOT - inside-out trans-obturator tape/sling

Intervention Type: 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)

Interventions

TOT - inside-out trans-obturator tape/sling

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)

Intervention Type: DEVICE

SIS - Innovative fixation single incision sling

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)

Intervention Type: DEVICE

Other Intervention Names

Gynecare TVT Obturator System (Ethicon); Ophira (Promedon)

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Martin Huser

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 21412819 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24880654 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37888839 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36735422 (View on PubMed)

Other Identifiers

BrnoUH

Identifier Type: -

Identifier Source: org_study_id