Clinical trial NCT03829137: The Clinical Effects of Laser Acupuncture Therapy for OAB Women.
Official title: The Clinical Effects of Laser Acupuncture Therapy for OAB Women: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: OAB symptom score (OABSS)
timeFrame: 3 weeks
Secondary outcomes:
measure: The Urogenital Distress Inventory (UDI-6)
timeFrame: 3 weeks
Other outcomes:
measure: Incontinence Impact Questionnaire (IIQ-7)
timeFrame: 3 weeks
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Hsin-Ning Chang
role: STUDY_CHAIR
References: