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Clinical Trials/NCT03516435
NCT03516435
Unknown
Not Applicable

Randomized,Single-Blind Controlled Trial

Chung Shan Medical University1 site in 1 country30 target enrollmentApril 9, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overactive Bladder Syndrome
Sponsor
Chung Shan Medical University
Enrollment
30
Locations
1
Primary Endpoint
3 Days Voiding diary
Last Updated
7 years ago

Overview

Brief Summary

This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.

Detailed Description

This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.The study will adopt a longitudinal research design with randomized quasi-experimental trial.The patients will recruited and be randomly assigned to Group A (Parasacral transcutaneous electrical stimulation) or Group B (Intravaginal electrical stimulation). There will be 30 participants in each group. Data will be collected 2 times.

Registry
clinicaltrials.gov
Start Date
April 9, 2018
End Date
February 28, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yeh

Professor

Chung Shan Medical University

Eligibility Criteria

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

Outcomes

Primary Outcomes

3 Days Voiding diary

Time Frame: 3 days

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.

Secondary Outcomes

  • Pad test(20min-1hr)
  • Overactive Bladder Symptom Score( OABSS)(20 min)
  • minVisual analogue scale (VAS) for urgency(10 min)

Study Sites (1)

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