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
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
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
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
NCT ID
NCT04036578
First Posted
May 3, 2019
Last Updated
July 25, 2019
Sponsor
Far Eastern Memorial Hospital
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
Learn more about this trial
Efficacy of Biofeedback in Women With Pelvic Floor Dysfunction
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