Clinical trial NCT05997992: Clinical Efficacy Evaluation of Electroacupuncture as Adjuvant Therapy for Female Patients With Overactive Bladder
Official title: Clinical Efficacy Evaluation of Electroacupuncture as Adjuvant Therapy for Female Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder
Keywords: Urge Incontinence
Overactive bladder
quality of life
TCM constitution,
Electroacupuncture
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research is a single-blind randomized controlled human trial.The research is a single-blind randomized controlled human trial. It is planned to select 100 women aged 20-80 years with a diagnosis of OAB in outpatient clinics, and divide them into an experimental group and a control group of 50 each. The experimental group received electroacupuncture at Baihui(GV20), bilateral Sanyinjiao(SP-6) and Fuliu points(KP-7); the control group received placebo acupuncture
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urinary tract related questionnair
timeFrame: Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.
measure: King's Health Quality of Life Questionnaire(KHQ)
timeFrame: Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.
measure: Heart rate variability(HRV)
timeFrame: Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.
Secondary outcomes:
measure: Is the dose of the drug reduced?
timeFrame: Every week will record the dose that participants take.A total of 8 weeks.
measure: Are the side effects reduced?
timeFrame: Every week will record side effects of taking medicine.A total of 8 weeks.
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Buddhist Taipei Tzu Chi General Hospital
Study officials:
References: