Efficacy of Different Electrical Stimulation Placement in Patients With Overactive Bladder Syndrome

Randomized,Single-Blind Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder Syndrome
• Intervention / Treatment: Device: Parasacral transcutaneous electrical stimulation; Device: Intravaginal electrical stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40201
    • Recruiting
    • Chung Shan Medical University Hospital
    • Contact: Phone Number: 21737 886-4-24739595; Email: irb@csh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parasacral transcutaneous ES; 20min./session, 2 sessions/week ,12 sessions of Parasacral transcutaneous electrical stimulation.	Device: 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.
Active Comparator: Intravaginal electrical stimulation; 20min./session, 2 sessions/week ,12 sessions of Intravaginal electrical stimulation.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overactive Bladder Symptom Score( OABSS）	This is a single symptom score that employs a self-report questionnaire to quantify OAB symptoms.Questionnaire has many items with the same minimum and maximum score.Four question items, daytime frequency, nocturia, urgency and urgency incontinence, were included in the questionnaire according to the definition of OAB.	20 min
minVisual analogue scale (VAS) for urgency	The Visual Analog or Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of urgency they experienced. This gives them the greatest freedom to choose their urgency intensity. It also gives the maximum opportunity for each respondent to express a personal response style. VAS data of this type is recorded as the number of millimeters from the left of the line with the range 0-100.	10 min
Pad test	To measure leakage and may be performed in the specialist's office or at home. Pad testing can be done over a period of time as short as twenty minutes or up to one hour.	20min-1hr

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Anticipated): November 30, 2018
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Intravaginal electrical stimulation; Parasacral transcutaneous electrical stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Disease; Urinary Bladder, Overactive; Syndrome
• Other Study ID Numbers: CS17150

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No