Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
FEMALE
ID05997992

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

Led by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Updated on 2025-06-05

100

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Overactive bladder (OAB) is a condition commonly marked by frequent urination and nocturia, which can cause psychological stress and impact interpersonal relationships, reducing quality of life for women. Treatments include lifestyle changes, behavioral therapy, medications, neuromodulation, botulinum toxin, and surgery. Anticholinergic drugs are often first-line but have side effects like dry mouth that reduce adherence. This research evaluates electroacupuncture, a traditional Chinese medicine technique similar to transcutaneous tibial nerve stimulation, as an additional treatment for women with OAB receiving conventional Western medicine. Participants are randomly assigned to one of two groups. The electroacupuncture group receives treatment at specific acupoints (Baihui, bilateral Sanyinjiao, and Fuliu) for 20 minutes twice weekly. The control group receives placebo acupuncture where needles do not penetrate the skin and the electroacupuncture device is not activated, but otherwise treatment is similar. The study lasts 8 weeks, including treatment and follow-up. During the 8-week study, participants complete urinary tract symptom questionnaires, the King's Health Quality of Life Questionnaire, and heart rate variability assessments at the start and every two weeks, with a one-week break after six weeks. Researchers also track medication dose and side effects weekly. These measures help assess symptom improvement, quality of life, and autonomic nervous system function. The study aims to understand how electroacupuncture may support women managing OAB.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patient aged 20-80 with overactive bladder.
Not Eligible

You will not qualify if you...

  • History of cancer, stroke, or hyperthyroidism.
  • Unwillingness to accept acupuncture or moxibustion treatment.
  • Pregnant or planning to become pregnant.
  • Current urinary tract infection.
  • Previous treatment with botulinum toxin (Botox), PTNS, or SMN.
  • Previous acupuncture treatment.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 8 weeks

Participants receive electroacupuncture or sham acupuncture at specific acupoints twice a week while continuing conventional Western medicine treatment for overactive bladder.

Twice weekly visits for 8 weeks

Follow-up

Duration - 8 weeks

Participants complete questionnaires and have assessments of urinary symptoms, quality of life, and heart rate variability throughout the 8-week study period.

Five questionnaire rounds including initial, biweekly, and final assessments over 8 weeks

Trial Site Locations

Total: 1 location

1

Buddhist Taipei Tzu Chi General Hospital

New Taipei City, Taiwan

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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