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

Primary Purpose

Overactive Bladder Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Parasacral transcutaneous electrical stimulation
Intravaginal electrical stimulation
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring Intravaginal electrical stimulation, Parasacral transcutaneous electrical stimulation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chung Shan Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parasacral transcutaneous ES

Intravaginal electrical stimulation

Arm Description

20min./session, 2 sessions/week ,12 sessions of Parasacral transcutaneous electrical stimulation.

20min./session, 2 sessions/week ,12 sessions of Intravaginal electrical stimulation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 24, 2018
Last Updated
May 14, 2018
Sponsor
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03516435
Brief Title
Efficacy of Different Electrical Stimulation Placement in Patients With Overactive Bladder Syndrome
Official Title
Randomized,Single-Blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
Keywords
Intravaginal electrical stimulation, Parasacral transcutaneous electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parasacral transcutaneous ES
Arm Type
Experimental
Arm Description
20min./session, 2 sessions/week ,12 sessions of Parasacral transcutaneous electrical stimulation.
Arm Title
Intravaginal electrical stimulation
Arm Type
Active Comparator
Arm Description
20min./session, 2 sessions/week ,12 sessions of Intravaginal electrical stimulation.
Intervention Type
Device
Intervention Name(s)
Parasacral transcutaneous electrical stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Intravaginal electrical stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
3 Days Voiding diary
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Overactive Bladder Symptom Score( OABSS）
Description
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.
Time Frame
20 min
Title
minVisual analogue scale (VAS) for urgency
Description
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.
Time Frame
10 min
Title
Pad test
Description
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.
Time Frame
20min-1hr

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Gin-Den, PhD
Phone
+886-4-24730022
Ext
11600
Email
gdchentw@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Yi-Ching, MS
Phone
+886-4-24730022
Ext
12378
Email
yiching@csmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Gin-Den, PhD
Organizational Affiliation
Chung Shan Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chen Yi-Ching, MS
Organizational Affiliation
Chung Shan Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chang Chia-Yun, MS student
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
886-4-24739595
Ext
21737
Email
irb@csh.gov.tw

12. IPD Sharing Statement

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

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