The Clinical Effects of Laser Acupuncture Therapy for OAB Women.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Clinical Effects of Laser Acupuncture Therapy for OAB Women: a Randomized Controlled Trial.

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: Verum laser acupuncture
* Device: Sham laser acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women are older than 18 years old. Participant is willing to sign the consent. Women havea moderate OAB symptoms. Total scores of OABSS > 6 points and the 3rd question of OABSS > 2 points. Not using anticholinergic drugs for more than three weeks. Exclusion Criteria: Patients with lower urinary tract infection. Patients who cannot complete the questionnaire. Patients who use Botox to inject bladder and pelvic floor muscles within one year. Pregnant patients. Patients who continue to have electrical stimulation and acupuncture in the legs, waist and pelvis. Patients with vaginal bleeding. Other herbal and folklore therapies are being used to improve patients with overactive bladder.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum laser acupuncture<br>Verum laser acupuncture：Low level laser therapy stimulates 7 acupuncture points on both sides of the body . | Device: Verum laser acupuncture<br>* 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.<br>|
| Sham Comparator: Sham laser acupuncture<br>sham laser acupuncture (no laser output) | Device: Sham laser acupuncture<br>* The acupuncture points and procedure of the control group are identical to the experimental group but there are no laser beam energy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OAB symptom score (OABSS) | This is a four symptoms questionnaire to quantify OAB symptoms. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Urogenital Distress Inventory (UDI-6) | This evaluation scale assesses symptom distress. | 3 weeks |