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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03516435 |
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Date of registration:
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24/04/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Different Electrical Stimulation Placement in Patients With Overactive Bladder Syndrome
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Scientific title:
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Randomized,Single-Blind Controlled Trial |
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Date of first enrolment:
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April 9, 2018 |
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Target sample size:
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30 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03516435 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Chang Chia-Yun, MS student |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chung Shan Medical University |
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Name:
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Chen Gin-Den, PhD |
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Address:
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Telephone:
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+886-4-24730022 |
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Email:
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gdchentw@hotmail.com |
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Affiliation:
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Name:
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Chen Gin-Den, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chung Shan Medical University |
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Name:
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Chen Yi-Ching, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chung Shan Medical University |
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Name:
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Address:
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Telephone:
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886-4-24739595 |
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Email:
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irb@csh.gov.tw |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Overactive Bladder Syndrome
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Intervention(s)
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Device: Intravaginal electrical stimulation
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Device: Parasacral transcutaneous electrical stimulation
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Primary Outcome(s)
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3 Days Voiding diary
[Time Frame: 3 days]
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Secondary Outcome(s)
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Pad test
[Time Frame: 20min-1hr]
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Overactive Bladder Symptom Score( OABSS)
[Time Frame: 20 min]
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minVisual analogue scale (VAS) for urgency
[Time Frame: 10 min]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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