Overactive Bladder
Conditions
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.
Interventions
DEVICEVerum 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.
DEVICESham laser acupuncture
The acupuncture points and procedure of the control group are identical to the experimental group but there are no laser beam energy.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OAB symptom score (OABSS) | 3 weeks | This is a four symptoms questionnaire to quantify OAB symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Urogenital Distress Inventory (UDI-6) | 3 weeks | This evaluation scale assesses symptom distress. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incontinence Impact Questionnaire (IIQ-7) | 3 weeks | This evaluation scale assesses the impact on daily life of urinary incontinence. |
Countries
Taiwan
Contacts
Primary ContactHsin-Ning Chang
Outcome results
None listed