The Clinical Effects of Laser Acupuncture Therapy for OAB Women.

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03829137
• Other study ID #: 201801679A3
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 5, 2022

Study information

• Verified date: January 2019
• Source: Chang Gung Memorial Hospital
• Contact: Hsin-Ning Chang
• Phone: (02)24313131
• Email: 8705015[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 5, 2022
• Est. primary completion date: April 5, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incontinence Impact Questionnaire (IIQ-7)	This evaluation scale assesses the impact on daily life of urinary incontinence.	3 weeks
Primary	OAB symptom score (OABSS)	This is a four symptoms questionnaire to quantify OAB symptoms.	3 weeks
Secondary	The Urogenital Distress Inventory (UDI-6)	This evaluation scale assesses symptom distress.	3 weeks