Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder

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

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-16

Study Completion Date

2021-12-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of 210 women with overactive bladder will be recruited and randomized to 3 arms: drug only, exercise only and combination arm.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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combination of drug and exercise

Participant will be prescribed with oral medication in combination with biofeedback-assisted pelvic floor muscle training (PFMT) during the first month, participant will continue to have biofeedback assisted PFMT for another 2 months

Group Type EXPERIMENTAL

Solifenacin Succinate 5mg/tab daily

Intervention Type DRUG

participants will be taking oral medication for 3 months

biofeedback-assisted pelvic floor muscle training

Intervention Type BEHAVIORAL

participants will be doing biofeedback-assisted pelvic floor muscle training for 3 months

drug only

Participant will be prescribed with oral medication for 3 months

Group Type ACTIVE_COMPARATOR

Solifenacin Succinate 5mg/tab daily

Intervention Type DRUG

participants will be taking oral medication for 3 months

exercise only

Participant will be doing biofeedback-assisted pelvic floor muscle training for 3 months

Group Type ACTIVE_COMPARATOR

biofeedback-assisted pelvic floor muscle training

Intervention Type BEHAVIORAL

participants will be doing biofeedback-assisted pelvic floor muscle training for 3 months

Interventions

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Solifenacin Succinate 5mg/tab daily

participants will be taking oral medication for 3 months

Intervention Type DRUG

biofeedback-assisted pelvic floor muscle training

participants will be doing biofeedback-assisted pelvic floor muscle training for 3 months

Intervention Type BEHAVIORAL

Other Intervention Names

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Vesicare 5mg/tab daily

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 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No