Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: a Pilot Multicentered, Randomized, Parallel, Sham-controlled Trial

Kyunghee University2 sites in 1 country56 target enrollmentJune 2016

ConditionsUrinary Incontinence Stroke, Complication

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Urinary Incontinence
Sponsor: Kyunghee University
Enrollment: 56
Locations: 2
Primary Endpoint: Total Urgency and Frequency Score (TUFS)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

June 1, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kyunghee University

Responsible Party

Principal Investigator

Lee Eui-ju

Professor

Kyunghee University

Eligibility Criteria

Inclusion Criteria

•Male or female aged over 19 years old
•Patients diagnosed with stroke (cerebral hemorrhage or infarction) by the examination of computed tomography or magnetic resonance imaging methods within 2 years
•Twice or more of urination with 3 to 4 points of PPIUS\* at baseline OR 13 points or more of K-IPSS\*
•Any volunteers who signed the informed consent forms

Exclusion Criteria

•We will exclude any patients with
•Once or more of post-voiding residual \> 200 ml per day
•Clinically significant stress urinary incontinence diagnosed based on cough induction test or investigator's decision
•Recurrent urinary tract infection defined as 4 or more treatments for urinary tract infection for the recent 1 year
•Cognitive impairment with less than 23 points of MMSE-K\* examination
•Acute or chronic lower urinary tract infection examined by urine culture
•Urinary incontinence diagnosed before the stroke occurred and the symptoms have continued until now based on medical history
•Any severe diseases in lower urinary tract based on medical history and screening examination
•Coagulation disorders based on medical history
•Peripheral arterial diseases, which resulted in taking medical or surgical procedures to treat them based on medical history

Outcomes

Primary Outcomes

Total Urgency and Frequency Score (TUFS)

Time Frame: at least 15 days (at most 21 days) (at baseline and the end of the treatment)

The patients will be asked to fill the scale about their perception of urgency intensity (24 hours before the 1st session and after the last session, respectively) by themselves. They have to record every time of urination and select one of the 5 levels in perception of urgency intensity (0=No urgency, 1=Mild urgency, 2=Moderate urgency, 3=Severe urgency, 4= urgency incontinence) for 24 hours at baseline and the end of the treatment, respectively.

Secondary Outcomes

International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ-UI-SF)(at least 15 days (at most 21 days) (at baseline and the end of the treatment))
The Korean version of International Prostate Symptom Scale (K-IPSS)(at least 15 days (at most 21 days) (at baseline and the end of the treatment))
The Lower urinary track system Outcome Score (LOS)(at least 15 days (at most 21 days) (at baseline and the end of the treatment))
Adverse events report(intraoperative)