The Clinical Effects of Laser Acupuncture Therapy for OAB Women.

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

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.

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: Verum laser acupuncture; Device: Sham laser acupuncture

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsin-Ning Chang; Phone Number: 2777 (02)24313131; Email: 8705015@cgmh.org.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Hsin-Ning Chang; Email: 8705015@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incontinence Impact Questionnaire (IIQ-7)	This evaluation scale assesses the impact on daily life of urinary incontinence.	3 weeks

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Hsin-Ning Chang, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): April 5, 2022
• Study Completion (ANTICIPATED): April 5, 2022

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (ACTUAL): February 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 201801679A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No