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The Clinical Effects of Laser Acupuncture Therapy for OAB Women.

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ClinicalTrials.gov Identifier: NCT03829137
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
Overactive bladder (OAB) is a syndrome causes urgency, with or without urgent incontinence, daytime frequency and nocturia. Urgency incontinence is more common in older women and may be associated with comorbid conditions that occur with age. The standard OAB medical treatments may induced several intolerable side effects including dry mouth, constipation, and so on, therefore alternative therapies are often considered. Acupuncture had been proved effective to OAB treatment, however, this invasive procedure also cause pain and hematoma. Laser acupuncture has minimal side effects comparing to conventional acupuncture, but its effects against OAB had never been examined. Experiments with laser acupuncture are expected to be another way to relieve OAB symptoms.

Condition or disease Intervention/treatment Phase
Overactive Bladder Device: Verum laser acupuncture Device: Sham laser acupuncture Not Applicable

Detailed Description:
The subjects are treated with 7 acupoints which are localized according to WHO standardized acupressure point location guideline. The patients lay in the supine position before treatment and the gallium aluminum arsenide LaserPan (RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany) will be applied to each selected acupoints mentioned above. The experimental group (verum laser acupuncture) and control group (sham laser acupuncture) will receive laser acupuncture 3 times per week for 3 weeks, total of 9 sessions, based on clinical experience (Treatment could be extended if necessary). The basic patient data will be recorded at baseline and adverse effect will also be recorded during the clinical trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Clinical Effects of Laser Acupuncture Therapy for OAB Women: a Randomized Controlled Trial.
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : April 5, 2022
Estimated Study Completion Date : April 5, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Verum laser acupuncture
Verum laser acupuncture:Low level laser therapy stimulates 7 acupuncture points on both sides of the body .
Device: Verum laser acupuncture
The patients lay in the supine position before treatment and the gallium aluminum arsenide LaserPan (RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany) will be applied to each selected acupoints for 3 weeks, total of 9 sessions.

Sham Comparator: Sham laser acupuncture
sham laser acupuncture (no laser output)
Device: Sham laser acupuncture
The acupuncture points and procedure of the control group are identical to the experimental group but there are no laser beam energy.




Primary Outcome Measures :
  1. OAB symptom score (OABSS) [ Time Frame: 3 weeks ]
    This is a four symptoms questionnaire to quantify OAB symptoms.


Secondary Outcome Measures :
  1. The Urogenital Distress Inventory (UDI-6) [ Time Frame: 3 weeks ]
    This evaluation scale assesses symptom distress.


Other Outcome Measures:
  1. Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: 3 weeks ]
    This evaluation scale assesses the impact on daily life of urinary incontinence.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women are older than 18 years old.
  2. Participant is willing to sign the consent.
  3. Women havea moderate OAB symptoms.
  4. Total scores of OABSS > 6 points and the 3rd question of OABSS > 2 points.
  5. Not using anticholinergic drugs for more than three weeks.

Exclusion Criteria:

  1. Patients with lower urinary tract infection.
  2. Patients who cannot complete the questionnaire.
  3. Patients who use Botox to inject bladder and pelvic floor muscles within one year.
  4. Pregnant patients.
  5. Patients who continue to have electrical stimulation and acupuncture in the legs, waist and pelvis.
  6. Patients with vaginal bleeding.
  7. Other herbal and folklore therapies are being used to improve patients with overactive bladder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829137


Contacts
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Contact: Hsin-Ning Chang (02)24313131 ext 2777 8705015@cgmh.org.tw

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Hsin-Ning Chang       8705015@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Hsin-Ning Chang Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03829137     History of Changes
Other Study ID Numbers: 201801679A3
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms