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Transobturator Urethral Sling Placement With an Autologous Rectus Facia

Primary Purpose

Stress Urinary Incontinence, Surgery--Complications

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mid-urethral sling placement using autologous rectus fascia
Mid-urethral sling placement using synthetic mesh
Sponsored by
Ankara Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring midurethral sling placement, synthetic mesh, autologous rectus fascia, transobturator approach

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female patients that underwent mid-urethral sling placement

Exclusion Criteria:

  • active urinary infection
  • neurologic disorders
  • malignancies
  • history of radiotherapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    autologous fascia

    synthetic mesh

    Arm Description

    Patients who underwent a transobturator sling placement using autologous rectus fascia

    Patients who underwent a transobturator sling placement using synthetic mesh

    Outcomes

    Primary Outcome Measures

    ICIQ-SF
    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

    Treatment Benefit Scale
    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''

    Full Information

    First Posted
    May 13, 2019
    Last Updated
    August 23, 2021
    Sponsor
    Ankara Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03949348
    Brief Title
    Transobturator Urethral Sling Placement With an Autologous Rectus Facia
    Official Title
    Transobturator Urethral Sling Placement With an Autologous Rectus Facia for Female Stress Urinary Incontinence.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2016 (Actual)
    Primary Completion Date
    January 1, 2019 (Actual)
    Study Completion Date
    January 1, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Urinary Incontinence, Surgery--Complications
    Keywords
    midurethral sling placement, synthetic mesh, autologous rectus fascia, transobturator approach

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients who undergo a transobturator sling placement using autologous rectus fascia
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    autologous fascia
    Arm Type
    Active Comparator
    Arm Description
    Patients who underwent a transobturator sling placement using autologous rectus fascia
    Arm Title
    synthetic mesh
    Arm Type
    Active Comparator
    Arm Description
    Patients who underwent a transobturator sling placement using synthetic mesh
    Intervention Type
    Procedure
    Intervention Name(s)
    Mid-urethral sling placement using autologous rectus fascia
    Intervention Description
    Mid-urethral sling placement using autologous rectus fascia
    Intervention Type
    Procedure
    Intervention Name(s)
    Mid-urethral sling placement using synthetic mesh
    Intervention Description
    Mid-urethral sling placement using synthetic mesh
    Primary Outcome Measure Information:
    Title
    ICIQ-SF
    Description
    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.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Treatment Benefit Scale
    Description
    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''
    Time Frame
    2 years

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Surgery for female stress urinary incontinence
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: female patients that underwent mid-urethral sling placement Exclusion Criteria: active urinary infection neurologic disorders malignancies history of radiotherapy

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    27036519
    Citation
    Linder BJ, Elliott DS. Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-term Outcomes. Urology. 2016 Jul;93:55-9. doi: 10.1016/j.urology.2016.03.025. Epub 2016 Mar 29.
    Results Reference
    result
    PubMed Identifier
    25444955
    Citation
    Linder BJ, Elliott DS. Autologous transobturator urethral sling placement for female stress urinary incontinence. J Urol. 2015 Mar;193(3):991-6. doi: 10.1016/j.juro.2014.08.125. Epub 2014 Oct 19.
    Results Reference
    result

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    Transobturator Urethral Sling Placement With an Autologous Rectus Facia

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