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Transobturator Verus Single Incision Slings

Primary Purpose

Urinary Incontinence, Stress

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mini-arc
Monarc
Sponsored by
Cecilia Calvo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.

Exclusion Criteria:

  • Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Monarc

    Mini-arc

    Arm Description

    Placement of a transobturator monarc sling for stress urinary incontinence

    Placement of a single incision mini-arc sling for stress urinary incontinence

    Outcomes

    Primary Outcome Measures

    Objective Stress Urinary Incontinence
    The primary outcome was presence of leakage during cough stress test(CST) on examination

    Secondary Outcome Measures

    Quality of Life Questionnaire UDI-6
    Response to validated questionnaire: Urinary Distress Index(UDI-6) Measures symptoms on three subscales: 1. Irritative 2. Stress 3. Obstructive/Discomfort. The mean value of all questions answered is then multiplied by 25 for the actual score (range 0 to 100) Summary score - Add the scores from the 3 scales together to obtain the summary score (range 0 to 300) The higher the score the greater the perceived impact that pelvic floor dysfunction has on a patient's life.
    Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence
    Assess if the patient has any complaint of stress urinary incontinence after surgery in follow up visits. This will be history only, no examination.
    Number of Participants Who Completed Self- Assessment of Cure
    Self-assessment of cure is based on 5 point scale, cured, greatly improved, somewhat improved, not improved, and worsened. This is calculated by the number of patients that were analyzed.
    Quality of Life Questionnaire IIQ-7
    Response to validated questionnaire: Incontinence Impact Questionnaire(IIQ-7) The IIQ measures the impact of urinary incontinence on activities roles, and emotional states. A mean score is derived from each domain, then transferred to give weight to each subscale. Subscale scores range from 0-100. The total IIQ score is calculated by adding the four subscales score with a range of 0-400 possible. A score closer to 0 represents activities not affected at all versus closer to 400 represent activities that were greatly affected.
    Quality of Life Questionnaire ICIQ
    Response to validated questionnaire: International Consultation on Incontinence Questionnaire(ICIQ). The ICIQ is a screening tool for incontinence. The scoring scale is 0-21, minimum 0, maximum 21. a higher score indicates greater impairment from incontinence.

    Full Information

    First Posted
    November 3, 2015
    Last Updated
    June 28, 2023
    Sponsor
    Cecilia Calvo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02599051
    Brief Title
    Transobturator Verus Single Incision Slings
    Official Title
    Transobturator Versus Single Incision Slings: 1 Year Results of a Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    January 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Cecilia Calvo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling
    Detailed Description
    Transobturator slings are one type of sling that has become standard treatment for stress urinary incontinence. However, this procedure involves a total of 3 incisions to perform. In contrast, single incision slings have been developed to treat stress urinary incontinence by using only one incision. However, to date the success and complications of these two procedures have not been compared or studied.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence, Stress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    98 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Monarc
    Arm Type
    Active Comparator
    Arm Description
    Placement of a transobturator monarc sling for stress urinary incontinence
    Arm Title
    Mini-arc
    Arm Type
    Experimental
    Arm Description
    Placement of a single incision mini-arc sling for stress urinary incontinence
    Intervention Type
    Device
    Intervention Name(s)
    Mini-arc
    Other Intervention Name(s)
    single incision sling
    Intervention Description
    We will place a single incision sling at the time of surgery for stress urinary incontinence
    Intervention Type
    Device
    Intervention Name(s)
    Monarc
    Other Intervention Name(s)
    transobturator sling
    Intervention Description
    We will place a transobturator sling at the time of surgery for stress urinary incontinence
    Primary Outcome Measure Information:
    Title
    Objective Stress Urinary Incontinence
    Description
    The primary outcome was presence of leakage during cough stress test(CST) on examination
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Quality of Life Questionnaire UDI-6
    Description
    Response to validated questionnaire: Urinary Distress Index(UDI-6) Measures symptoms on three subscales: 1. Irritative 2. Stress 3. Obstructive/Discomfort. The mean value of all questions answered is then multiplied by 25 for the actual score (range 0 to 100) Summary score - Add the scores from the 3 scales together to obtain the summary score (range 0 to 300) The higher the score the greater the perceived impact that pelvic floor dysfunction has on a patient's life.
    Time Frame
    1 year
    Title
    Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence
    Description
    Assess if the patient has any complaint of stress urinary incontinence after surgery in follow up visits. This will be history only, no examination.
    Time Frame
    1 year
    Title
    Number of Participants Who Completed Self- Assessment of Cure
    Description
    Self-assessment of cure is based on 5 point scale, cured, greatly improved, somewhat improved, not improved, and worsened. This is calculated by the number of patients that were analyzed.
    Time Frame
    1 year
    Title
    Quality of Life Questionnaire IIQ-7
    Description
    Response to validated questionnaire: Incontinence Impact Questionnaire(IIQ-7) The IIQ measures the impact of urinary incontinence on activities roles, and emotional states. A mean score is derived from each domain, then transferred to give weight to each subscale. Subscale scores range from 0-100. The total IIQ score is calculated by adding the four subscales score with a range of 0-400 possible. A score closer to 0 represents activities not affected at all versus closer to 400 represent activities that were greatly affected.
    Time Frame
    1 year
    Title
    Quality of Life Questionnaire ICIQ
    Description
    Response to validated questionnaire: International Consultation on Incontinence Questionnaire(ICIQ). The ICIQ is a screening tool for incontinence. The scoring scale is 0-21, minimum 0, maximum 21. a higher score indicates greater impairment from incontinence.
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment. Exclusion Criteria: Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    G Willy Davila, MD
    Organizational Affiliation
    Cleveland Clinic Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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