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

Overactive Bladder Syndrome Clinical Trial

Official title:

Randomized,Single-Blind Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03516435
• Other study ID #: CS17150
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: May 2018
• Source: Chung Shan Medical University
• Contact: Chen Gin-Den, PhD
• Phone: +886-4-24730022
• Email: gdchentw[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 28, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Syndrome
• Urinary Bladder, Overactive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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