Efficacy of Different Electrical Stimulation Placement in Patients With Overactive Bladder Syndrome
Randomized,Single-Blind Controlled Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2018
CompletedFirst Submitted
Initial submission to the registry
April 24, 2018
CompletedFirst Posted
Study publicly available on registry
May 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedMay 17, 2018
May 1, 2018
8 months
April 24, 2018
May 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3 Days Voiding diary
This chart is a record of your voiding and leakage or urine. Choose three (3) separate 24 hour periods to complete this record. Pick days which will be most convenient for you to measure every void.
3 days
Secondary Outcomes (3)
Overactive Bladder Symptom Score( OABSS）
20 min
minVisual analogue scale (VAS) for urgency
10 min
Pad test
20min-1hr
Study Arms (2)
Parasacral transcutaneous ES
EXPERIMENTAL20min./session, 2 sessions/week ,12 sessions of Parasacral transcutaneous electrical stimulation.
Intravaginal electrical stimulation
ACTIVE COMPARATOR20min./session, 2 sessions/week ,12 sessions of Intravaginal electrical stimulation.
Interventions
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.
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
You may qualify if:
- Urinary incontinence due to detrusor overactivity
- 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.
You may not qualify if:
- stress incontinence
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Study Officials
- STUDY CHAIR
Chen Gin-Den, PhD
Chung Shan Medical University
- STUDY DIRECTOR
Chen Yi-Ching, MS
Chung Shan Medical University
- PRINCIPAL INVESTIGATOR
Chang Chia-Yun, MS student
Chung Shan Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 24, 2018
First Posted
May 4, 2018
Study Start
April 9, 2018
Primary Completion
November 30, 2018
Study Completion
February 28, 2019
Last Updated
May 17, 2018
Record last verified: 2018-05