Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder

NCT04477265 | Completed

• 1 other identifier: 105019 - F
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

Overactive; drug only; exercise only; combination of drug and exercise

Outcome Measures

Primary Outcomes (6)

• 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.

Study Arms (3)

combination of drug and exercise

EXPERIMENTAL

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; Behavioral: biofeedback-assisted pelvic floor muscle training

drug only

ACTIVE COMPARATOR

Participant will be prescribed with oral medication for 3 months

Drug: Solifenacin Succinate 5mg/tab daily

exercise only

ACTIVE COMPARATOR

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

Behavioral: biofeedback-assisted pelvic floor muscle training

Interventions

Solifenacin Succinate 5mg/tab daily DRUG

participants will be taking oral medication for 3 months

Also known as: Vesicare 5mg/tab daily

combination of drug and exercise; drug only

biofeedback-assisted pelvic floor muscle training BEHAVIORAL

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

combination of drug and exercise; exercise only

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Motor Activity

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Wen-Yih Wu

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 210 women with overactive bladder will be recruited and randomized to 3 arms: drug only, exercise only and combination arm.

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: July 20, 2020
• Study Start: June 16, 2016
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: January 28, 2022

Record last verified: 2020-05

Locations

TW (1)