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Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder (PFMT)

Primary Purpose

Overactive Bladder

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Solifenacin Succinate 5mg/tab daily

biofeedback-assisted pelvic floor muscle training

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive, drug only, exercise only, combination of drug and exercise

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Far Eastern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

combination of drug and exercise

drug only

exercise only

Arm 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

Participant will be prescribed with oral medication for 3 months

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

Outcomes

Primary Outcome Measures

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).

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) .

change of electromyographic activity

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)

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)

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

to assess motivation with PFMT, consists of 14 items.The scale scored between 1 (worst) and 6(best) .

Secondary Outcome Measures

Full Information

NCT ID

NCT04477265

First Posted

June 15, 2020

Last Updated

January 26, 2022

Sponsor

Far Eastern Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04477265

Brief Title

Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder

Acronym

PFMT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

June 16, 2016 (Actual)

Primary Completion Date

December 24, 2021 (Actual)

Study Completion Date

December 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Far Eastern Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

Overactive, drug only, exercise only, combination of drug and exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

combination of drug and exercise

Arm Type

Experimental

Arm Description

Arm Title

drug only

Arm Type

Active Comparator

Arm Description

Participant will be prescribed with oral medication for 3 months

Arm Title

exercise only

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Solifenacin Succinate 5mg/tab daily

Other Intervention Name(s)

Vesicare 5mg/tab daily

Intervention Description

participants will be taking oral medication for 3 months

Intervention Type

Behavioral

Intervention Name(s)

biofeedback-assisted pelvic floor muscle training

Intervention Description

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

Primary Outcome Measure Information:

Title

3-Day Voiding Diary

Description

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).

Time Frame

Baseline through study completion, an average of 12 weeks.

Title

Symptom Distress scale(SDS)

Description

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) .

Time Frame