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NCT Number: NCT05997992

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

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Buddhist Taipei Tzu Chi General Hospital

New Taipei City, Taiwan

Location status: Recruiting

Location contact

H. C. Wu, MD.

CONTACT

[email protected]

+886266289009

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Sham acupuncture

Device

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

Primary outcomes

  1. Urinary tract related questionnair

    Time frame: 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.

    Measuring OAB scores to record the differ between two groups and time.Higher scores indicate more severe symptoms of overactive bladder syndrome.

  2. King's Health Quality of Life Questionnaire(KHQ)

    Time frame: 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.

    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.

  3. Heart rate variability(HRV)

    Time frame: 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.

    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.

Secondary outcomes

  1. Is the dose of the drug reduced?

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

    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.

  2. Are the side effects reduced?

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

    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.

Sponsors and collaborators

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Aug 18, 2023
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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