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Transobturator Urethral Sling Placement With an Autologous Rectus Facia

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ClinicalTrials.gov Identifier: NCT03949348
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Muhammet Fatih Kilinc, Ankara Training and Research Hospital

Study Description
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Brief Summary:
The investigators aimed to evaluate outcomes of transobturator urethral sling placement using autologous rectus fascia for female stress urinary incontinence at perioperatively and at 2-year follow-up.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Surgery--Complications Procedure: Mid-urethral sling placement using autologous rectus fascia Procedure: Mid-urethral sling placement using synthetic mesh Not Applicable

Detailed Description:

Stress urinary incontinence (SUI) is very common condition in middle-aged women, and can affect quality of life. Some clinical trials reported that the lifetime risk of a woman undergoing surgery for SUI is increase in up to 15%. The midurethral synthetic sling is the most common surgery performed for female SUI. This procedure has high efficacy and low perioperative morbidity.

Although many clinical trials have demonstrated that synthetic mid-urethral slings are safe, effective and recommended by several guidelines (e.g. Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction/American Urogynecologic Society and American Urologic Association), the safety and efficacy of surgery for SUI using mesh devices has been questioned by a community of patients and clinicians. After Food and Drug Administration notification on mesh use in pelvic surgery, many patients and providers begin to search of different surgery without synthetic mesh alternatives in SUI. Recently, female patients in England formed the campaign group "Sling the Mesh" to protest the synthetic mesh.

Several options such as the autologous pubovaginal sling, biologic grafts, or urethral bulking agent injection have some problems related to morbidity or efficacy. The autologous pubovaginal urethral sling is associated with a higher risk of postoperative voiding dysfunction.

The investigators aimed to demonstrate the feasibility of an autologous transobturator urethral sling to avoid the related problems of synthetic mesh placement and the increased rate of voiding dysfunction with pubovaginal sling placement.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients who undergo a transobturator sling placement using autologous rectus fascia
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transobturator Urethral Sling Placement With an Autologous Rectus Facia for Female Stress Urinary Incontinence.
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: autologous fascia
Patients who underwent a transobturator sling placement using autologous rectus fascia
 Procedure: Mid-urethral sling placement using autologous rectus fascia
Mid-urethral sling placement using autologous rectus fascia
Active Comparator: synthetic mesh
Patients who underwent a transobturator sling placement using synthetic mesh
 Procedure: Mid-urethral sling placement using synthetic mesh
Mid-urethral sling placement using synthetic mesh


Outcome Measures
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Primary Outcome Measures :
  1. ICIQ-SF [ Time Frame: 2 years ]
    The ICIQ-UI Short Form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in women in research and clinical practice across the world. It is scored on a scale from 0-21; higher values represent worse outcomes. The ICIQ-UI Short Form provides a brief and robust measure to assess the impact of symptoms of incontinence on outcome.


Secondary Outcome Measures :
  1. Treatment Benefit Scale [ Time Frame: 2 years ]
    TBS consists of four categories scored as 1 (greatly improved) or 2 (improved), considered as ''yes,'' or 3 (not changed) or 4 (worsened), which were considered as ''no''


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Surgery for female stress urinary incontinence
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patients that underwent mid-urethral sling placement

Exclusion Criteria:

  • active urinary infection
  • neurologic disorders
  • malignancies
  • history of radiotherapy
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

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Responsible Party: Muhammet Fatih Kilinc, Principal invastigator, Ankara Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03949348    
Other Study ID Numbers: 0635
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Muhammet Fatih Kilinc, Ankara Training and Research Hospital:
midurethral sling placement
synthetic mesh
autologous rectus fascia
transobturator approach
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders