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

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ClinicalTrials.gov Identifier: NCT05997992
Recruitment Status : Recruiting
First Posted : August 18, 2023
Last Update Posted : August 18, 2023
Sponsor:
Information provided by (Responsible Party):
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study Description
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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.


Condition or disease Intervention/treatment Phase
Overactive Bladder Device: electroacupuncture Device: sham acupuncture Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Clinical Efficacy Evaluation of Electroacupuncture as Adjuvant Therapy for Female Patients With Overactive Bladder
Actual Study Start Date : January 11, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Electroacupuncture group

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
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.
Placebo Comparator: Sham acupuncture group
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
Acupuncture does not penetrate the skin, and the electroacupuncture machine is not plugged in.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05997992


Locations
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Taiwan
Buddhist Taipei Tzu Chi General Hospital Recruiting
New Taipei City, Taiwan
Contact: H. C. Wu, MD.    +886266289009    xuang@tzuchi.com.tw   
Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier: NCT05997992    
Other Study ID Numbers: 11-XD-071
First Posted: August 18, 2023    Key Record Dates
Last Update Posted: August 18, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:
Urge Incontinence
Overactive bladder
quality of life
TCM constitution,
Electroacupuncture
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
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