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Efficacy of Biofeedback in Women With Pelvic Floor Dysfunction

Primary Purpose

Pelvic Floor Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A 12-week PFMT bio-assisted surface electromyographic program
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Dysfunction focused on measuring pelvic floor dysfunction, pelvic floor muscle training, pelvic organ prolapse, surface electromyographic program

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. pelvic organ prolapse for more than 3 months
  2. more then 20 year old,less then 85 year old and acceptable to receive vaginal examination
  3. need to match schedule with the investigator's clinic for 5 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 12 weeks of pelvic floor muscle exercises

Exclusion Criteria:

  1. women who were unable to contract their PFMs due to cognitive deficit
  2. had a neurological disorder
  3. pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Pelvic Floor Dysfunction With and Without POP

    Arm Description

    group 1(Pelvic Floor Dysfunction Without POP Stage I~II) and group 2(Pelvic Floor Dysfunction With POP Stage I~II)

    Outcomes

    Primary Outcome Measures

    electromyographic activity
    Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) during each session of PFMT(µV)
    prolapse severity
    The prolapse severity was assessed subjectively and objectively (using the POP Quantification System) before and after the intervention in women with POP.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 3, 2019
    Last Updated
    July 25, 2019
    Sponsor
    Far Eastern Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04036578
    Brief Title
    Efficacy of Biofeedback in Women With Pelvic Floor Dysfunction
    Official Title
    Efficacy of Pelvic Floor Muscle Training Using Bio-assisted Surface Electromyography in Women With Pelvic Floor Dysfunction With and Without Pelvic Organ Prolapse
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2015 (Actual)
    Primary Completion Date
    January 24, 2018 (Actual)
    Study Completion Date
    November 2, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Far Eastern Memorial Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Recent studies have found that pelvic floor muscle training can relieve pelvic organ prolapse related symptoms. However, the rate of cure or improvement of symptoms with exercise prescription, different compliance of the patient's behavior have great differences. Biofeedback is an instrument used to record the biological signals ( electrical activity) during a voluntary pelvic floor muscle contraction and provide feedback in auditory or visual form (a louder sound with a stronger squeeze or an increasing number of lights on a visual display as the strength of the squeeze increased). Therefore, this study would explore the efficacy of biofeedback-assisted pelvic floor muscle training in women with pelvic floor dysfunction with or without organ prolapse.
    Detailed Description
    Treatment options for pelvic floor dysfunction (PFD) vary depending on symptom severity. Conservative approaches such as pelvic floor muscle (PFM) exercises, biofeedback, and lifestyle advice are usually suggested for urgency incontinence (UI), overactive bladder (OAB), and mild-to-moderate pelvic organ prolapse (POP). Conservative management remains the gold standard of treatment for female UI and OAB. There is Level 1, Grade A evidence supporting pelvic floor muscle training (PFMT) as an effective treatment for UI and OAB, and Grade B evidence that pelvic floor muscle training (PFMT) reduces the symptoms of urogenital prolapse, although topographic changes are not expected. Most of the past literatures focused on the effectiveness of PFMT on single disease, but seldom explored its effectiveness on complex disease (i.e. women presenting with more than one type of PFD). In the real world, some degree of POP was present in 41% to 50% of women on physical examination, but only 3% of patients reported symptoms such as bearing down sensation of vagina. Besides, there was a number of studies that assessed the efficacy of PFMT as a treatment for women with POP, but rarely explored its effectiveness in both subjective and objective (anatomic) improvement of prolapse severity. Biofeedback provides positive reinforcement to patients performing PFMT, therefore improves the quality of life of women with PFD. It can be achieved via several methods, including electromyography (EMG), manometry, or ultrasonography. A systematic review confirmed the benefit of adding of biofeedback to PFMT, but it was not clear whether this was the effect was related to another variable, such as the amount of health professional contact rather than the biofeedback.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Floor Dysfunction
    Keywords
    pelvic floor dysfunction, pelvic floor muscle training, pelvic organ prolapse, surface electromyographic program

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    A 12-week PFMT bio-assisted surface electromyographic program in group 1(Pelvic Floor Dysfunction Without POP Stage I~II) and group 2(Pelvic Floor Dysfunction With POP Stage I~II)
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    83 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pelvic Floor Dysfunction With and Without POP
    Arm Type
    Other
    Arm Description
    group 1(Pelvic Floor Dysfunction Without POP Stage I~II) and group 2(Pelvic Floor Dysfunction With POP Stage I~II)
    Intervention Type
    Device
    Intervention Name(s)
    A 12-week PFMT bio-assisted surface electromyographic program
    Primary Outcome Measure Information:
    Title
    electromyographic activity
    Description
    Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) during each session of PFMT(µV)
    Time Frame
    Change from Baseline Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) at 0,2,4,8,12 week
    Title
    prolapse severity
    Description
    The prolapse severity was assessed subjectively and objectively (using the POP Quantification System) before and after the intervention in women with POP.
    Time Frame
    Change from Baseline prolapse severity with subjectively and objectively (using the POP Quantification System) at 12 week

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: pelvic organ prolapse for more than 3 months more then 20 year old,less then 85 year old and acceptable to receive vaginal examination need to match schedule with the investigator's clinic for 5 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 12 weeks of pelvic floor muscle exercises Exclusion Criteria: women who were unable to contract their PFMs due to cognitive deficit had a neurological disorder pregnant

    12. IPD Sharing Statement

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    Efficacy of Biofeedback in Women With Pelvic Floor Dysfunction

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