Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder

Not Applicable

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Solifenacin Succinate 5mg/tab daily; Behavioral: biofeedback-assisted pelvic floor muscle training

• Registration Number: NCT04477265
• Lead Sponsor: Far Eastern Memorial Hospital

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.

Study Timeline

• Study Start: 2016-06-16
• Status Verified: 2020-05
• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-20
• Primary Completion: 2021-12-24
• Study Completion: 2021-12-24
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug only	Solifenacin Succinate 5mg/tab daily	Participant will be prescribed with oral medication for 3 months
combination of drug and exercise	Solifenacin Succinate 5mg/tab daily	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
combination of drug and exercise	biofeedback-assisted pelvic floor muscle training	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
exercise only	biofeedback-assisted pelvic floor muscle training	Participant will be doing biofeedback-assisted pelvic floor muscle training for 3 months

Primary Outcome Measures

Name	Time	Method
3-Day Voiding Diary	Baseline through study completion, an average of 12 weeks.	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).
Symptom Distress scale(SDS)	through study completion, an average of 12 weeks.	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) .
change of electromyographic activity	through study completion, an average of 12 weeks.	Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) during each session of PFMT(µV)
King's Health Questionnaire (KHQ)	through study completion, an average of 12 weeks.	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 .
A five-item Self-Assessment of Treatment (SAT)	through study completion, an average of 12 weeks.	to assess improvement and satisfaction with treatment, consists of 1 item. The scale scored between 1 (worst) and 5 (best ) .
A five-item Self-Assessment of Self-efficacy	through study completion, an average of 12 weeks.	to assess motivation with PFMT, consists of 14 items.The scale scored between 1 (worst) and 6(best) .

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 New Taipei City, Taiwan