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The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder

Primary Purpose

Overactive Bladder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Control
Sponsored by
Ataturk Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Having a diagnosis of overactive bladder
  • Being volunteer

Exclusion Criteria:

  • have a neurological disorder
  • only those with stress urinary incontinence
  • presence of advanced pelvic organ prolapse (stage 3-4)
  • Having a mental problem that will prevent cooperation in evaluation and / or applications
  • Women with the presence of malignant condition

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Exercise group

    Control group

    Arm Description

    Fast and slow contractions will be taught in PFMT. For fast contractions, they will be asked to contract and relax the pelvic floor muscles quickly. For slow contractions, they will be asked to contract the pelvic floor muscles slowly, keep them at maximum contraction and relax slowly. Ten slow contractions in addition to 10 fast contractions will be considered as 1 set of exercises. For the first week, they will be asked to do 5 sets of exercises per day, every day. Then, the number of sets will be increased by 5 each week and the number of sets will reach 30 in the 6th week. PFMT will be applied by the patients as a home program every day of the week for 6 weeks.

    Waiting list will included in control group.

    Outcomes

    Primary Outcome Measures

    Pelvic floor muscle strength
    The pelvic floor muscle strength of the patients will be evaluated by digital palpation. Change in pelvic floor muscle strength as measured with the Modified Oxford Scale, which ranges from 0 to 5
    Sexual Function
    Female sexual function will be assessed using the Female Sexual Function Index. This 19-question questionnaire deals with the subject in a multidimensional way by questioning the states of desire, arousal, lubrication, orgasm, satisfaction and pain. The highest raw score that can be obtained from the questionnaire is 95, and the lowest raw score is 4.

    Secondary Outcome Measures

    OAB symptoms
    OAB symptoms will be evaluated OAB-V8. There are 8 questions in this form and the answers given to each question are scored between 0 and 5. The scores that can be obtained from the entire scale range from 0 to 40.
    Urinary frequency, nocturia and the number of urinary incontinence
    Patients will be also instructed to keep voiding diary
    Life quality
    Life quality will be assessed with King's Health Questionnaire (KHQ).This questionnaire consists of two parts and 32 items.. The minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health).

    Full Information

    First Posted
    June 27, 2021
    Last Updated
    June 27, 2021
    Sponsor
    Ataturk Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04950556
    Brief Title
    The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder
    Official Title
    The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2021 (Anticipated)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    August 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of our study is to investigate the effects of pelvic floor muscle training (PFMT) on pelvic floor muscle strength, sexual functions, bladder symptoms and quality of life in women with overactive bladder (OAB).
    Detailed Description
    Overactive bladder (OAB) is defined by the International Continence Association as an "urgency with or without urge urinary incontinence, often accompanied by frequency and nocturia." Accordingly, pelvic floor muscle training (PFMT) plays an important role in the management of OAB. However, a recent systematic review suggests that PFMT is insufficient against OAB.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overactive Bladder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomly divided into two groups (control and exercise) for treatment.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise group
    Arm Type
    Experimental
    Arm Description
    Fast and slow contractions will be taught in PFMT. For fast contractions, they will be asked to contract and relax the pelvic floor muscles quickly. For slow contractions, they will be asked to contract the pelvic floor muscles slowly, keep them at maximum contraction and relax slowly. Ten slow contractions in addition to 10 fast contractions will be considered as 1 set of exercises. For the first week, they will be asked to do 5 sets of exercises per day, every day. Then, the number of sets will be increased by 5 each week and the number of sets will reach 30 in the 6th week. PFMT will be applied by the patients as a home program every day of the week for 6 weeks.
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Waiting list will included in control group.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    Pelvic floor muscle exercise will be given to the exercise group
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    No intervention
    Primary Outcome Measure Information:
    Title
    Pelvic floor muscle strength
    Description
    The pelvic floor muscle strength of the patients will be evaluated by digital palpation. Change in pelvic floor muscle strength as measured with the Modified Oxford Scale, which ranges from 0 to 5
    Time Frame
    change from baseline at 6 weeks
    Title
    Sexual Function
    Description
    Female sexual function will be assessed using the Female Sexual Function Index. This 19-question questionnaire deals with the subject in a multidimensional way by questioning the states of desire, arousal, lubrication, orgasm, satisfaction and pain. The highest raw score that can be obtained from the questionnaire is 95, and the lowest raw score is 4.
    Time Frame
    change from baseline at 6 weeks
    Secondary Outcome Measure Information:
    Title
    OAB symptoms
    Description
    OAB symptoms will be evaluated OAB-V8. There are 8 questions in this form and the answers given to each question are scored between 0 and 5. The scores that can be obtained from the entire scale range from 0 to 40.
    Time Frame
    change from baseline at 6 weeks
    Title
    Urinary frequency, nocturia and the number of urinary incontinence
    Description
    Patients will be also instructed to keep voiding diary
    Time Frame
    change from baseline at 6 weeks
    Title
    Life quality
    Description
    Life quality will be assessed with King's Health Questionnaire (KHQ).This questionnaire consists of two parts and 32 items.. The minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health).
    Time Frame
    change from baseline at 6 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Having a diagnosis of overactive bladder Being volunteer Exclusion Criteria: have a neurological disorder only those with stress urinary incontinence presence of advanced pelvic organ prolapse (stage 3-4) Having a mental problem that will prevent cooperation in evaluation and / or applications Women with the presence of malignant condition
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seyda Toprak Celenay
    Phone
    +90312 906 1000
    Email
    sydtoprak@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Seyda Toprak Celenay
    Organizational Affiliation
    Ankara Yildirim Beyazıt University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder

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