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Completed

NCT Number: NCT02819336

Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

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

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Key information

Conditions

Urinary Incontinence Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Stroke, Complication Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wonkwang University Gwangju Medical Center, Gwangju, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Psychiatric diseases based on medical history
  • Fear of acupuncture based on questionnaire test
  • Pregnancy based on urine test
  • Any other inappropriate reasons on which the primary or sub investigators do not let the patients participate in the trial
  • Abbreviations PPIUS; Patient Perception of Intensity of Urgency Scale K-IPSS; The Korean version of International Prostate Symptom Scale MMSE-K; The Korean version of Mini-Mental State Examination

Treatment and study plan

Electroacupuncture (EA)

Device

The EA group will receive the verum therapies using the following procedures.

  • Let the patient lie down on lateral decubitus.
  • The practitioners install the same guide-tubes as Park sham needle on CV2, CV3, CV4, CV6 and bilateral points of SP11 and SP6.
  • The verum acupunctures are inserted on each acupoint inside the installed guide-tube. (stainless steel, 0.25 mm in diameter and 4.0 mm in length, Dong Bang Acupuncture Inc., Republic of Korea)
  • After de qi response is elicited, the electrical stimulation is presented for 20 minutes by middle frequency (30 Hz). (STN-111, Stratek, Republic of Korea)
  • The practitioner should have at least 1-year clinical experiences.

The procedure will be repeated 10 times (once a session) within 21 days.

Other names: STN-111, Stratek, Republic of Korea

Sham electroacupuncture

Device
  • Let the patient lie down on lateral decubitus.
  • The practitioners install the same guide-tubes as Park sham needle on CV2, CV3, CV4, and CV6 unilaterally & SP11 and SP6 bilaterally.
  • The non-penetrating sham acupunctures are implemented on each acupoint inside the installed guide-tube.
  • The electrical stimulation is presented for 20 minutes by middle frequency (30 Hz), (STN-111, Stratek, Republic of Korea) even though the electrical stimulation is not delivered through the skin because the needles are not penetrated through the skin.
  • The practitioner should have at least 1-year clinical experiences.

The procedure will be repeated 10 times (once a session) within 21 days.

Other names: Park sham device

Primary outcomes

  1. 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

  1. International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ-UI-SF)

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

  2. The Korean version of International Prostate Symptom Scale (K-IPSS)

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

  3. The Lower urinary track system Outcome Score (LOS)

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

  4. Adverse events report

    Time frame: intraoperative

Other outcomes

  1. Blinding Index (BI)

    Time frame: 21 days

    Patients will be asked to answer which arm they think they belonged to, assessing that the blinding succeed or not.

Sponsors and collaborators

Lead sponsor

Kyunghee University

Other

Collaborators

  • Wonkwang University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2016
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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