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The Clinical Effects of Laser Acupuncture Therapy for OAB Women.

Primary Purpose

Overactive Bladder

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Verum laser acupuncture
Sham laser acupuncture
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Verum laser acupuncture

Sham laser acupuncture

Arm Description

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

sham laser acupuncture (no laser output)

Outcomes

Primary Outcome Measures

OAB symptom score (OABSS)
This is a four symptoms questionnaire to quantify OAB symptoms.

Secondary Outcome Measures

The Urogenital Distress Inventory (UDI-6)
This evaluation scale assesses symptom distress.

Full Information

First Posted
January 31, 2019
Last Updated
February 1, 2019
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03829137
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
April 5, 2022 (Anticipated)
Study Completion Date
April 5, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verum laser acupuncture
Arm Type
Experimental
Arm Description
Verum laser acupuncture：Low level laser therapy stimulates 7 acupuncture points on both sides of the body .
Arm Title
Sham laser acupuncture
Arm Type
Sham Comparator
Arm Description
sham laser acupuncture (no laser output)
Intervention Type
Device
Intervention Name(s)
Verum laser acupuncture
Intervention Description
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
Intervention Name(s)
Sham laser acupuncture
Intervention Description
The acupuncture points and procedure of the control group are identical to the experimental group but there are no laser beam energy.
Primary Outcome Measure Information:
Title
OAB symptom score (OABSS)
Description
This is a four symptoms questionnaire to quantify OAB symptoms.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
The Urogenital Distress Inventory (UDI-6)
Description
This evaluation scale assesses symptom distress.
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
Incontinence Impact Questionnaire (IIQ-7)
Description
This evaluation scale assesses the impact on daily life of urinary incontinence.
Time Frame
3 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-Ning Chang
Phone
(02)24313131
Ext
2777
Email
8705015@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsin-Ning Chang
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsin-Ning Chang
Email
8705015@cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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The Clinical Effects of Laser Acupuncture Therapy for OAB Women.

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