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

Far Eastern Memorial Hospital

Status: Enrolling

Conditions: Intrinsic Sphincter Deficiency; Urethral Hypermobility; Stress Urinary Incontinence

Treatments: Behavioral: surface electromyographic biofeedback and electrical stimulation; Behavioral: surface electromyographic biofeedback assisted pelvic floor muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT05272644

109184-F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: Female

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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 vaginal examination
3. need to match schedule with the investigator's clinic for 45 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 8 weeks of pelvic floor muscle exercises

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 muscle exercises.
6. Women during pregnancy.
7. Maternity within six weeks after delivery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 4 patient groups

urethral hypermobility-surface electromyographic biofeedback only

Active Comparator group

Description:

Participant will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months

Treatment:

Behavioral: surface electromyographic biofeedback assisted pelvic floor muscle training

urethral hypermobility-surface electromyographic biofeedback and electrical stimulation

Experimental group

Description:

Participant will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months

Treatment:

Behavioral: surface electromyographic biofeedback and electrical stimulation

intrinsic sphincter deficiency-surface electromyographic biofeedback only

Active Comparator group

Description:

Participant will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months

Treatment:

Behavioral: surface electromyographic biofeedback assisted pelvic floor muscle training

intrinsic sphincter deficiency-surface electromyographic biofeedback and electrical stimulation

Experimental group

Description:

Participant will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months

Treatment:

Behavioral: surface electromyographic biofeedback and electrical stimulation