Clinical trial NCT05272644: Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Stress Urinary Incontinence
Official title: Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Different Pathophysiological Classifications of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Urethral Hypermobility
Intrinsic Sphincter Deficiency
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 128
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: King's Health Questionnaire (KHQ)
timeFrame: Time Frame: through study completion, an average of 8 weeks
measure: A five-item Self-Assessment of Treatment (SAT)
timeFrame: Time Frame: through study completion, an average of 8 weeks.
measure: Sandvik urinary incontinence severity test
timeFrame: Time Frame: through study completion, an average of 8 weeks
measure: Symptom Indexes for Stress Incontinence
timeFrame: Time Frame: through study completion, an average of 8 weeks
Secondary outcomes:
measure: Introital and transvaginal ultrasound in the assessment of urogenital and pelvic floor dysfunction
timeFrame: Time Frame: through study completion, an average of 8 weeks
measure: one-hour pad test
timeFrame: Time Frame: through study completion, an average of 8 weeks
measure: change of electromyographic activity
timeFrame: Time Frame: through study completion, an average of 8 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References: