Efficacy of Different Electrical Stimulation Placement in Patients With Overactive Bladder Syndrome
NCT ID: NCT03516435
Last Updated: 2018-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-04-09
2019-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Parasacral transcutaneous ES
20min./session, 2 sessions/week ,12 sessions of Parasacral transcutaneous electrical stimulation.
Parasacral transcutaneous electrical stimulation
Asymmetrical biphasic square current pulse Frequency：10 Hz pulse width：1.0 ms Intensity：highest tolerable intensity(≦80 mA.) Parasacral transcutaneous electrical stimulation：Clinic using 2 superficial 3.5 cm electrodes placed on each side of S3 and S4.
Intravaginal electrical stimulation
20min./session, 2 sessions/week ,12 sessions of Intravaginal electrical stimulation.
Intravaginal electrical stimulation
Asymmetrical biphasic square current pulse Frequency：10 Hz pulse width：1.0 ms Intensity：highest tolerable intensity(≦80 mA.) Intravaginal electrical stimulation：The electrode plug for vaginal plug was cylinder-formed with ring-formed placed into vaginal.
Interventions
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Parasacral transcutaneous electrical stimulation
Asymmetrical biphasic square current pulse Frequency：10 Hz pulse width：1.0 ms Intensity：highest tolerable intensity(≦80 mA.) Parasacral transcutaneous electrical stimulation：Clinic using 2 superficial 3.5 cm electrodes placed on each side of S3 and S4.
Intravaginal electrical stimulation
Asymmetrical biphasic square current pulse Frequency：10 Hz pulse width：1.0 ms Intensity：highest tolerable intensity(≦80 mA.) Intravaginal electrical stimulation：The electrode plug for vaginal plug was cylinder-formed with ring-formed placed into vaginal.
Eligibility Criteria
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Inclusion Criteria
* No patients had been taking anticholinergics or tricyclic depressants and none had been treated by pelvic floor exercise, bladder training, or pelvic surgery before entry into the study.
Exclusion Criteria
* urinary tract infection
* neurological disease
* genital prolapse higher than stage II on POP-Q system
* pregnancy
* diabetes mellitus
* a history of anti-incontinence surgery and/or prolapse repair
* pelvic tumors and previously treated with radiation therapy or antimuscarinic agents
* patients who were not cooperative
* electrical stimulation contraindications
20 Years
FEMALE
Yes
Sponsors
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Chung Shan Medical University
OTHER
Responsible Party
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Yeh
Professor
Principal Investigators
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Chen Gin-Den, PhD
Role: STUDY_CHAIR
Chung Shan Medical University
Chen Yi-Ching, MS
Role: STUDY_DIRECTOR
Chung Shan Medical University
Chang Chia-Yun, MS student
Role: PRINCIPAL_INVESTIGATOR
Chung Shan Medical University
Locations
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Chung Shan Medical University Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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CS17150
Identifier Type: -
Identifier Source: org_study_id
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