Clinical trial NCT04477265: Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder
Official title: Efficacy of of Pelvic Floor Muscle Training( PFMT ) With Surface Electromyographic Biofeedback and Medication in Women With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: Overactive
drug only
exercise only
combination of drug and exercise
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 210 women with overactive bladder will be recruited and randomized to 3 arms: drug only, exercise only and combination arm.
Primary purpose: TREATMENT

Brief summary: Medical treatment for overactive bladder is acceptable widely. However, the effect of drug treatment is different due to compliance and side effect of the drug. Biofeedback-assisted pelvic floor muscle training (PFMT) is the first line recommendation for overactive bladder. The slow effect of biofeedback-assisted pelvic floor muscle training leads to low motivation for continuous treatment and results in compliance difference. This slow effect also changes the degree of improvement in the treatment of overactive bladder. This study is designed to evaluate the efficacy of combination therapy for treatment of female overactive bladder.

Detailed description: Participant will be prescribed with oral medication in combination with biofeedback-assisted pelvic floor muscle training (PFMT) for the first month. Participant will continue to have biofeedback assisted PFMT for another two months without oral medication. The investigators expected that combination therapy will improve the compliance and severity of symptoms in women with overactive bladder.

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 5 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 12 weeks of pelvic floor muscle exercises

Exclusion Criteria:

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

Primary outcomes:
measure: 3-Day Voiding Diary
timeFrame: Baseline through study completion, an average of 12 weeks.
measure: Symptom Distress scale(SDS)
timeFrame: through study completion, an average of 12 weeks.
measure: change of electromyographic activity
timeFrame: through study completion, an average of 12 weeks.
measure: King's Health Questionnaire (KHQ)
timeFrame: through study completion, an average of 12 weeks.
measure: A five-item Self-Assessment of Treatment (SAT)
timeFrame: through study completion, an average of 12 weeks.
measure: A five-item Self-Assessment of Self-efficacy
timeFrame: through study completion, an average of 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Wen-Yih Wu
role: PRINCIPAL_INVESTIGATOR
References: