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

January 26, 2022 updated by: Far Eastern Memorial Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Drug: Solifenacin Succinate 5mg/tab daily
participants will be taking oral medication for 3 months
Other Names:
  • Vesicare 5mg/tab daily
Behavioral: biofeedback-assisted pelvic floor muscle training
participants will be doing biofeedback-assisted pelvic floor muscle training for 3 months
ACTIVE_COMPARATOR: drug only
Participant will be prescribed with oral medication for 3 months
Drug: Solifenacin Succinate 5mg/tab daily
participants will be taking oral medication for 3 months
Other Names:
  • Vesicare 5mg/tab daily
ACTIVE_COMPARATOR: exercise only
Participant will be doing biofeedback-assisted pelvic floor muscle training for 3 months
Behavioral: biofeedback-assisted pelvic floor muscle training
participants will be doing biofeedback-assisted pelvic floor muscle training for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-Day Voiding Diary
Time Frame: 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).
Baseline through study completion, an average of 12 weeks.
Symptom Distress scale(SDS)
Time Frame: 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) .
through study completion, an average of 12 weeks.
change of electromyographic activity
Time Frame: 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)
through study completion, an average of 12 weeks.
King's Health Questionnaire (KHQ)
Time Frame: 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 .
through study completion, an average of 12 weeks.
A five-item Self-Assessment of Treatment (SAT)
Time Frame: 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 ) .
through study completion, an average of 12 weeks.
A five-item Self-Assessment of Self-efficacy
Time Frame: 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) .
through study completion, an average of 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Investigators

  • Principal Investigator: Wen-Yih Wu, Far Eastern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 16, 2016

Primary Completion (ACTUAL)

December 24, 2021

Study Completion (ACTUAL)

December 24, 2021

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (ACTUAL)

July 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105019 - F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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