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Completed

NCT Number: NCT04477265

Efficacy of Biofeedback PFMT 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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solifenacin Succinate 5mg/tab daily

Drug

participants will be taking oral medication for 3 months

Other names: Vesicare 5mg/tab daily

biofeedback-assisted pelvic floor muscle training

Behavioral

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

Primary outcomes

  1. 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).

  2. 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) .

  3. 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)

  4. 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 .

  5. 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 ) .

  6. 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) .

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

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

Acronym: PFMT

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2020
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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