Efficacy of Biofeedback in Women With Pelvic Floor Dysfunction

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.

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Key information

Conditions

Pelvic Floor Dysfunction Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse

Age range

20 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A 12-week PFMT bio-assisted surface electromyographic program

Device

Primary outcomes

electromyographic activity

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

Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) during each session of PFMT(µV)
prolapse severity

Time frame: Change from Baseline prolapse severity with subjectively and objectively (using the POP Quantification System) at 12 week

The prolapse severity was assessed subjectively and objectively (using the POP Quantification System) before and after the intervention in women with POP.

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Jul 30, 2019
Registry last updated: Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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