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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-16

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

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Stress Urinary Incontinence Urethral Hypermobility Intrinsic Sphincter Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of 128 women with stress urinary incontinence will be divided into two groups: urethral hypermobility and intrinsic sphincter deficiency; and they will be further randomized to 2 arms: surface electromyographic biofeedback arm, surface electromyographic biofeedback and electrical stimulation arm

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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urethral hypermobility-surface electromyographic biofeedback only

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

Group Type ACTIVE_COMPARATOR

surface electromyographic biofeedback assisted pelvic floor muscle training

Intervention Type BEHAVIORAL

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

urethral hypermobility-surface electromyographic biofeedback and electrical stimulation

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

Group Type EXPERIMENTAL

surface electromyographic biofeedback and electrical stimulation

Intervention Type BEHAVIORAL

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

intrinsic sphincter deficiency-surface electromyographic biofeedback only

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

Group Type ACTIVE_COMPARATOR

surface electromyographic biofeedback assisted pelvic floor muscle training

Intervention Type BEHAVIORAL

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

intrinsic sphincter deficiency-surface electromyographic biofeedback and electrical stimulation

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

Group Type EXPERIMENTAL

surface electromyographic biofeedback and electrical stimulation

Intervention Type BEHAVIORAL

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

Interventions

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surface electromyographic biofeedback assisted pelvic floor muscle training

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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No