Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder

Overactive Bladder Clinical Trial

— PFMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477265
• Other study ID #: 105019 - F
• Status: Completed
• Phase: N/A
• Start date: June 16, 2016
• Est. completion date: December 24, 2021

Study information

• Verified date: May 2020
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 24, 2021
• Est. primary completion date: December 24, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Solifenacin Succinate 5mg/tab daily
participants will be taking oral medication for 3 months

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

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.