Clinical Efficacy Evaluation of Electroacupuncture as Adjuvant Therapy for Female Patients With Overactive Bladder

Buddhist Tzu Chi Medical Foundation

Status: Enrolling

Conditions: Overactive Bladder

Treatments: Device: electroacupuncture; Device: sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05997992

11-XD-071

Details and patient eligibility

About

Overactive bladder (OAB) is often accompanied by frequent urination and nocturia, and does not necessarily manifest as urge incontinence. Urgency to urinate and frequent urination can lead to psychological burdens, affect interpersonal relationships and reduce women's quality of life.

Treatment of OAB includes lifestyle changes, behavioral therapy, drug therapy, neuromodulation, botulinum toxin therapy, and surgical intervention. At present, anticholinergic drugs are usually the first-line treatment for OAB, but the side effects of dry mouth often lead to poor patient compliance.

Transcutaneous tibial nerve stimulation (PTNS) is a minimally invasive neuromodulation technique. Past studies have confirmed that PTNS has clinical efficacy in treating symptoms related to overactive bladder, while TCM's electroacupuncture is similar to PTNS. The main purpose of this study was to evaluate the specific acupoints in accordance with traditional Chinese medicine theory in women with OAB under conventional Western medicine treatment to evaluate the improvement of women's related urinary tract symptoms, quality of life and autonomic nervous system function.

Full description

Overactive bladder (OAB) is often accompanied by frequent urination and nocturia, and does not necessarily manifest as urge incontinence. Urgency to urinate and frequent urination can lead to psychological burdens, affect interpersonal relationships and reduce women's quality of life.

Treatment of OAB includes lifestyle changes, behavioral therapy, drug therapy, neuromodulation, botulinum toxin therapy, and surgical intervention. At present, anticholinergic drugs are usually the first-line treatment for OAB, but the side effects of dry mouth often lead to poor patient compliance.

Transcutaneous tibial nerve stimulation (PTNS) is a minimally invasive neuromodulation technique. Past studies have confirmed that PTNS has clinical efficacy in treating symptoms related to overactive bladder, while TCM's electroacupuncture is similar to PTNS. The main purpose of this study was to evaluate the specific acupoints in accordance with traditional Chinese medicine theory in women with OAB under conventional Western medicine treatment to evaluate the improvement of women's related urinary tract symptoms, quality of life and autonomic nervous system function.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patient aged 20-80 with overactive bladder.

Exclusion criteria

• Patient has history of cancer, stroke, or hyperthyroidism..
• Patient isn't willing to accept acupuncture or moxibustion treatment.
• Patient who is pregnant or plan to pregnant.
• Patient with urinary tract infection.
• Patient who had injection of botulinum toxin (Botox®), PTNS or SMN treatment before.
• Patient recieved acupuncture treatment before.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Electroacupuncture group

Experimental group

Description:

The Electroacupuncture group received electroacupuncture at Baihui(GV20), bilateral Sanyinjiao(SP-6) and Fuliu points(KP-7).20 minutes of acupuncture. Twice a week.

Treatment:

Device: electroacupuncture

Sham acupuncture group

Placebo Comparator group

Description:

The control group received placebo acupuncture.Except for placebo acupuncture, which won't penetrate the skin, the rest is the same as the Electroacupuncture group.

Treatment:

Device: sham acupuncture