Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Stress Urinary Incontinence

Last updated: March 20, 2023
Sponsor: Far Eastern Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Incontinence

Enuresis

Treatment

N/A

Clinical Study ID

NCT05272644
109184-F
  • Ages 20-85
  • Female

Study Summary

The pathophysiological mechanism of stress urinary incontinence divides stress urinary incontinence into urethral hypermobility and intrinsic sphincter deficiency. Pelvic floor muscle exercise as first line therapy has been found to be extremely helpful in patients with mild to moderate forms of incontinence. Biofeedback uses an instrument to record the biological signals ( electrical activity) during a voluntary pelvic floor muscle contraction and present this information back to the woman in auditory or visual form. Electrical stimulation can aid in detecting pelvic floor muscles, and also promote the contraction of the pelvic floor muscles and strengthen the muscles. This study assumes that urinary incontinence women with different pathophysiological classifications receiving a pelvic floor muscle training with surface electromyographic biofeedback and electrical stimulation show differences in the strength of pelvic muscle and degree of symptoms improvement.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. overactivity bladder for more than 3 months
  2. more then 20 year old,less then 85 year old and acceptable to receive vaginalexamination
  3. need to match schedule with the investigator's clinic for 45 times,followed byindividual therapy, each takes about 30 to 60 minutes, a total of 8 weeks of pelvicfloor muscle exercises

Exclusion

Exclusion Criteria:

  1. Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury,peripheral neuropathy, etc.
  2. Kidney disease
  3. Liver disease
  4. Patients with cardiac rhythm devices.
  5. Insufficient cognitive function, unable to cooperate with pelvic floor muscleexercises.
  6. Women during pregnancy.
  7. Maternity within six weeks after delivery

Study Design

Total Participants: 128
Study Start date:
September 16, 2022
Estimated Completion Date:
December 31, 2023

Study Description

Participant will be assigned randomly to biofeedback-assisted pelvic floor muscle training (PFMT) group and biofeedback-assisted pelvic floor muscle training (PFMT) combined with electrical stimulation group. Each of the participant will receive the therapy for two months.The investigators expected that combination therapy will improve the compliance and severity of symptoms in women with stress urinary incontinence.

Connect with a study center

  • Far Eastern Memorial Hospital

    New Taipei City, 220
    Taiwan

    Active - Recruiting

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