Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder

Far Eastern Memorial Hospital

Status: Completed

Conditions: Overactive Bladder

Treatments: Drug: Solifenacin Succinate 5mg/tab daily; Behavioral: biofeedback-assisted pelvic floor muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT04477265

105019 - F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 20 to 80 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 3 patient groups

combination of drug and exercise

Experimental group

Description:

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

Treatment:

Behavioral: biofeedback-assisted pelvic floor muscle training

Drug: Solifenacin Succinate 5mg/tab daily

drug only

Active Comparator group

Description:

Participant will be prescribed with oral medication for 3 months

Treatment:

Drug: Solifenacin Succinate 5mg/tab daily

exercise only

Active Comparator group

Description:

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

Treatment:

Behavioral: biofeedback-assisted pelvic floor muscle training