NCT05272644

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Far Eastern Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stress Urinary Incontinence
• Urethral Hypermobility
• Intrinsic Sphincter Deficiency

Interventions

Type	Name	Description
BEHAVIORAL	surface electromyographic biofeedback assisted pelvic floor muscle training	participants will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months
BEHAVIORAL	surface electromyographic biofeedback and electrical stimulation	participants will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months

Timeline

• Start date: 2022-09-16
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-03-09
• Last updated: 2023-03-22

Locations

1 site across 1 country: Taiwan