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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997992
• Other study ID #: 11-XD-071
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• electroacupuncture
Electroacupuncture is a form of acupuncture where a small electric current is passed between pairs of acupuncture needles. According to some acupuncturists, this practice augments the use of regular acupuncture, can restore health and well-being, and is particularly good for treating pain.
• sham acupuncture
Acupuncture does not penetrate the skin, and the electroacupuncture machine is not plugged in.

Locations

Country	Name	City	State
Taiwan	Buddhist Taipei Tzu Chi General Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary tract related questionnair	Measuring OAB scores to record the differ between two groups and time.Higher scores indicate more severe symptoms of overactive bladder syndrome.	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.
Primary	King's Health Quality of Life Questionnaire(KHQ)	Measuring KHQ scores to record the differ between two groups and time.Higher scores indicate more significant impact of bladder-related issues on quality of life.	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.
Primary	Heart rate variability(HRV)	Measuring HRV to record the differ between two groups and time.Whether the balance of the autonomic nervous system in HRV can also be used to infer the severity of OAB symptoms is also an observation target for the researchers.	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	Is the dose of the drug reduced?	We record the doses of drugs that participants take.By comparing the differences in medication dosage over the course of 8 weeks, we aim to investigate the effectiveness of the therapeutic intervention.	Every week will record the dose that participants take.A total of 8 weeks.
Secondary	Are the side effects reduced?	We record participants' side effects after taking the drug.By comparing the differences in side effects over the course of 8 weeks, we aim to explore the effectiveness of the therapeutic intervention.	Every week will record side effects of taking medicine.A total of 8 weeks.