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Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence, Pelvic Floor Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvic Floor Muscle Training and Abdominal Training
Pelvic Floor Muscle Training
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress Urinary Incontinence focused on measuring exercise, pelvic floor, stress urinary incontinence

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria

  • 18-49 years
  • Meet the diagnosis of simple female stress urinary incontinence (Degree 0 or 1)
  • Volunteer to participate the study

Exclusion Criteria

  • BMI ≥30
  • Hysterectomy, urinary incontinence or pelvic floor operations
  • Chronic health problem (cardiovascular, cerebral, diabetes, liver, kidney, psychiatric disease, etc.)
  • Urge urinary incontinence, mixed urinary incontinence, overflow urinary incontinence
  • SUI Degree ≥2
  • Symptomatic urinary tract infection
  • During pregnancy or lactation period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PFMT + AT

    PFMT

    Arm Description

    Pelvic Floor Muscle Training and Abdominal Training

    Pelvic Floor Muscle Training

    Outcomes

    Primary Outcome Measures

    Change from baseline pelvic floor muscle strength at 8 weeks
    Pelvic floor muscle strength was measured using a perineometry device

    Secondary Outcome Measures

    Change from baseline UDI-6 score at 8 weeks
    Urinary symptoms were measured using the Urinary Distress Inventory (UDI-6)
    Change from baseline IIQ-7 score at 8 weeks
    Urinary symptoms were measured using the Incontinence Impact Questionnaire (IIQ-7),

    Full Information

    First Posted
    January 2, 2018
    Last Updated
    January 16, 2018
    Sponsor
    Trakya University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03401983
    Brief Title
    Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence
    Official Title
    Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    March 31, 2017 (Actual)
    Study Completion Date
    March 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Trakya University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study was to investigate the effectiveness of pelvic floor muscle and abdominal training in reproductive-age patients with stress urinary incontinence. This prospective randomized controlled design study included 64 female patients aged 18-49 years with stress urinary incontinence. The patients were divided into 2 groups (32 PFMT "Pelvic Floor Muscle Training" and 32 PFMT+AT "Abdominal Training") by computer-based randomization. The stress urinary incontinence type was assessed by a stress test, and the pelvic floor muscle strength was measured with a home biofeedback device. Voiding functions were assessed by a 3-day voiding diary and uroflowmetric test. The UDI-6 scale was used to assess the urinary symptoms, and the IIQ-7 scale was used to assess the quality of life. The follow-up measurements of both groups were obtained in the 0th, 4th, and 8th weeks.
    Detailed Description
    The aim of this study was to investigate the effectiveness of pelvic floor muscle and abdominal training in reproductive-age patients with stress urinary incontinence. This prospective randomized controlled design study included 64 female patients aged 18-49 years with stress urinary incontinence. The patients were divided into 2 groups (32 PFMT "Pelvic Floor Muscle Training" and 32 PFMT+AT "Abdominal Training") by computer-based randomization. The stress urinary incontinence type was assessed by a stress test, and the pelvic floor muscle strength was measured with a home biofeedback device. Voiding functions were assessed by a 3-day voiding diary and uroflowmetric test. The UDI-6 scale was used to assess the urinary symptoms, and the IIQ-7 scale was used to assess the quality of life. The follow-up measurements of both groups were obtained in the 0th, 4th, and 8th weeks. Participation of 29 patients from each group in the study was determined as sufficient to test the two-way hypothesis, with an effect size of 0.75, with an alpha level of 0.05, and with a power of 80%. However, 32 patients from each group were included as a precaution against possible missing data. These women were randomly divided into the PFMT+AT (n=32) and PFMT (n=32) groups using a computer based randomization scheme. The data were collected from both groups at the 0th, 4th, and 8th weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Urinary Incontinence, Pelvic Floor Muscle Weakness
    Keywords
    exercise, pelvic floor, stress urinary incontinence

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    PFMT + AT
    Arm Type
    Experimental
    Arm Description
    Pelvic Floor Muscle Training and Abdominal Training
    Arm Title
    PFMT
    Arm Type
    Active Comparator
    Arm Description
    Pelvic Floor Muscle Training
    Intervention Type
    Other
    Intervention Name(s)
    Pelvic Floor Muscle Training and Abdominal Training
    Intervention Description
    Pelvic Floor Muscle Training + Abdominal Training program was used in the study. The follow-up measurements of the PFMT+AT group were obtained in the 0th, 4th, and 8th weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Pelvic Floor Muscle Training
    Intervention Description
    Pelvic Floor Muscle Training program was used in the study. The follow-up measurements of the PFMT group were obtained in the 0th, 4th, and 8th weeks.
    Primary Outcome Measure Information:
    Title
    Change from baseline pelvic floor muscle strength at 8 weeks
    Description
    Pelvic floor muscle strength was measured using a perineometry device
    Time Frame
    0th, 4th, and 8th weeks.
    Secondary Outcome Measure Information:
    Title
    Change from baseline UDI-6 score at 8 weeks
    Description
    Urinary symptoms were measured using the Urinary Distress Inventory (UDI-6)
    Time Frame
    0th, 4th, and 8th weeks.
    Title
    Change from baseline IIQ-7 score at 8 weeks
    Description
    Urinary symptoms were measured using the Incontinence Impact Questionnaire (IIQ-7),
    Time Frame
    0th, 4th, and 8th weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria 18-49 years Meet the diagnosis of simple female stress urinary incontinence (Degree 0 or 1) Volunteer to participate the study Exclusion Criteria BMI ≥30 Hysterectomy, urinary incontinence or pelvic floor operations Chronic health problem (cardiovascular, cerebral, diabetes, liver, kidney, psychiatric disease, etc.) Urge urinary incontinence, mixed urinary incontinence, overflow urinary incontinence SUI Degree ≥2 Symptomatic urinary tract infection During pregnancy or lactation period

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence

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