Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder

Study Overview
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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.

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.

Official Title
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Efficacy of of Pelvic Floor Muscle Training( PFMT ) With Surface Electromyographic Biofeedback and Medication in Women With Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Solifenacin Succinate 5mg/tab daily
* Behavioral: biofeedback-assisted pelvic floor muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overactivity bladder for more than 3 months more then 20 year old,less then 85 year old and acceptable to receive vaginal examination 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: Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc. Glaucoma Kidney disease Liver disease Patients with cardiac rhythm devices. Insufficient cognitive function, unable to cooperate with pelvic floor muscle exercises. Women during pregnancy. Maternity within six weeks after delivery

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combination of drug and exercise<br>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 | Drug: Solifenacin Succinate 5mg/tab daily<br>* participants will be taking oral medication for 3 months<br>* Other names: Vesicare 5mg/tab daily;Behavioral: biofeedback-assisted pelvic floor muscle training<br>* participants will be doing biofeedback-assisted pelvic floor muscle training for 3 months<br>|
| Active Comparator: drug only<br>Participant will be prescribed with oral medication for 3 months | Drug: Solifenacin Succinate 5mg/tab daily<br>* participants will be taking oral medication for 3 months<br>* Other names: Vesicare 5mg/tab daily;|
| Active Comparator: exercise only<br>Participant will be doing biofeedback-assisted pelvic floor muscle training for 3 months | Behavioral: biofeedback-assisted pelvic floor muscle training<br>* participants will be doing biofeedback-assisted pelvic floor muscle training for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-Day Voiding Diary | to record urinary output, fluid consumed, and urinary leakage (if applicable) for 3 complete 24-hour periods (they do not have to be consecutive days). | Baseline through study completion, an average of 12 weeks. | 
| Symptom Distress scale(SDS) | the degree of discomfort from the specific symptoms being experienced, as perceived by the participants, consists of 23 items.The scale scored between 1 (best) and 5 (worst) . | through study completion, an average of 12 weeks. | 
| change of electromyographic activity | Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) during each session of PFMT(µV) | through study completion, an average of 12 weeks. | 
| King's Health Questionnaire (KHQ) | KHQ has 3 parts consisting of 21 items. Part 1 contains general health perception and incontinence impact (one item each). Part 2 contains role limitations, physical limitations, social limitations (two items each), personal relationships, emotions (three items each) and sleep/energy (two items), severity measures (four items).Part 3 is considered as a single item and contains ten responses in relation to frequency, nocturia, urgency,urge, stress, intercourse incontinence, nocturnal enuresis,infections, pain, and difficulty in voiding. The 4 subscales scored between 1 (best) and 4 (worst) in part 1 and 2. The Symptom Severity scale is scored from 0 (best) to 3 (worst) in part 3 . | through study completion, an average of 12 weeks. | 
| A five-item Self-Assessment of Treatment (SAT) | to assess improvement and satisfaction with treatment, consists of 1 item. The scale scored between 1 (worst) and 5 (best ) . | through study completion, an average of 12 weeks. | 
| A five-item Self-Assessment of Self-efficacy | to assess motivation with PFMT, consists of 14 items.The scale scored between 1 (worst) and 6(best) . | through study completion, an average of 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive, drug only, exercise only, combination of drug and exercise