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

Not Applicable

• Conditions: Overactive Bladder Syndrome
• Interventions: Device: Parasacral transcutaneous electrical stimulation; Device: Intravaginal electrical stimulation

• Registration Number: NCT03516435
• Lead Sponsor: Chung Shan Medical University

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.

Study Timeline

• Study Start: 2018-04-09
• Study First Submitted: 2018-04-24
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-04
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-17
• Primary Completion: 2018-11-30
• Study Completion: 2019-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parasacral transcutaneous ES	Parasacral transcutaneous electrical stimulation	20min./session, 2 sessions/week ,12 sessions of Parasacral transcutaneous electrical stimulation.
Intravaginal electrical stimulation	Intravaginal electrical stimulation	20min./session, 2 sessions/week ,12 sessions of Intravaginal electrical stimulation.

Primary Outcome Measures

Name	Time	Method
3 Days Voiding diary	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 Outcome Measures

Name	Time	Method
Pad test	20min-1hr	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.
Overactive Bladder Symptom Score( OABSS）	20 min	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	10 min	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.

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan