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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum laser acupuncture | Experimental | Verum laser acupuncture:Low level laser therapy stimulates 7 acupuncture points on both sides of the body . |
|
| Sham laser acupuncture | Sham Comparator | sham laser acupuncture (no laser output) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum laser acupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| OAB symptom score (OABSS) | This is a four symptoms questionnaire to quantify OAB symptoms. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Urogenital Distress Inventory (UDI-6) | This evaluation scale assesses symptom distress. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incontinence Impact Questionnaire (IIQ-7) | This evaluation scale assesses the impact on daily life of urinary incontinence. | 3 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsin-Ning Chang | Contact | (02)24313131 | 2777 | 8705015@cgmh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Hsin-Ning Chang | Chang Gung Memorial Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Sham laser acupuncture | Device | The acupuncture points and procedure of the control group are identical to the experimental group but there are no laser beam energy. |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |