Efficacy of Biofeedback in Women With Pelvic Floor Dysfunction

Efficacy of Pelvic Floor Muscle Training Using Bio-assisted Surface Electromyography in Women With Pelvic Floor Dysfunction With and Without Pelvic Organ Prolapse

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Dysfunction
• Intervention / Treatment: Device: A 12-week PFMT bio-assisted surface electromyographic program

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pelvic Floor Dysfunction With and Without POP; group 1(Pelvic Floor Dysfunction Without POP Stage I~II) and group 2(Pelvic Floor Dysfunction With POP Stage I~II)	Device: A 12-week PFMT bio-assisted surface electromyographic program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
electromyographic activity	Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) during each session of PFMT(µV)	Change from Baseline Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) at 0,2,4,8,12 week
prolapse severity	The prolapse severity was assessed subjectively and objectively (using the POP Quantification System) before and after the intervention in women with POP.	Change from Baseline prolapse severity with subjectively and objectively (using the POP Quantification System) at 12 week

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): January 24, 2018
• Study Completion (Actual): November 2, 2018

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: pelvic organ prolapse; pelvic floor muscle training; pelvic floor dysfunction; surface electromyographic program
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 104145-F

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No