The Clinical Effects of Laser Acupuncture Therapy for OAB Women.
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|ClinicalTrials.gov Identifier: NCT03829137|
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Device: Verum laser acupuncture Device: Sham laser acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||The Clinical Effects of Laser Acupuncture Therapy for OAB Women: a Randomized Controlled Trial.|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||April 5, 2022|
|Estimated Study Completion Date :||April 5, 2022|
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.
- OAB symptom score (OABSS) [ Time Frame: 3 weeks ]This is a four symptoms questionnaire to quantify OAB symptoms.
- The Urogenital Distress Inventory (UDI-6) [ Time Frame: 3 weeks ]This evaluation scale assesses symptom distress.
- Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: 3 weeks ]This evaluation scale assesses the impact on daily life of urinary incontinence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829137
|Contact: Hsin-Ning Chang||(02)24313131 ext firstname.lastname@example.org|
|Chang Gung Memorial Hospital||Recruiting|
|Contact: Hsin-Ning Chang email@example.com|
|Study Chair:||Hsin-Ning Chang||Chang Gung Memorial Hospital|