The Clinical Effects of Laser Acupuncture Therapy for OAB Women.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-04-05

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.

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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.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Verum laser acupuncture

Verum laser acupuncture：Low level laser therapy stimulates 7 acupuncture points on both sides of the body .

Group Type EXPERIMENTAL

Verum laser acupuncture

Intervention Type DEVICE

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 laser acupuncture

sham laser acupuncture (no laser output)

Group Type SHAM_COMPARATOR

Sham laser acupuncture

Intervention Type DEVICE

The acupuncture points and procedure of the control group are identical to the experimental group but there are no laser beam energy.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No