Efficacy of Biofeedback in Women With Pelvic Floor Dysfunction

NCT04036578 | Completed

• 1 other identifier: 104145-F
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Floor Dysfunction

Keywords

pelvic floor dysfunction; pelvic floor muscle training; pelvic organ prolapse; surface electromyographic program

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Pelvic Floor Dysfunction With and Without POP

OTHER

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

Interventions

A 12-week PFMT bio-assisted surface electromyographic program DEVICE

Pelvic Floor Dysfunction With and Without POP

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• women who were unable to contract their PFMs due to cognitive deficit
• had a neurological disorder
• pregnant

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: July 30, 2019
• Study Start: December 1, 2015
• Primary Completion: January 24, 2018
• Study Completion: November 2, 2018
• Last Updated: July 30, 2019

Record last verified: 2015-11