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

NCT05997992 | Recruiting

• 1 other identifier: 11-XD-071
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

Urge Incontinence; Overactive bladder; quality of life; TCM constitution,; Electroacupuncture

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (2)

• Is the dose of the drug reduced?

  Every week will record the dose that participants take.A total of 8 weeks.

• Are the side effects reduced?

  Every week will record side effects of taking medicine.A total of 8 weeks.

Study Arms (2)

Electroacupuncture group

EXPERIMENTAL

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

Device: electroacupuncture

Sham acupuncture group

PLACEBO COMPARATOR

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.

Device: sham acupuncture

Interventions

electroacupuncture DEVICE

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.

Electroacupuncture group

sham acupuncture DEVICE

Acupuncture does not penetrate the skin, and the electroacupuncture machine is not plugged in.

Sham acupuncture group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient aged 20-80 with overactive bladder.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Buddhist Taipei Tzu Chi General Hospital

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The research is a single-blind randomized controlled human trial.The participant will divide into control group or experimental group randomly by random number table.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: August 18, 2023
• Study Start: January 11, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

TW (1)