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Acupuncture for Overactive Bladder in Adults

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ClinicalTrials.gov Identifier: NCT05158361
Recruitment Status : Not yet recruiting
First Posted : December 15, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Ran Pang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Description
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Brief Summary:
The purpose of this study is to assess the effectiveness and safety of acupuncture for treating overactive bladder in adults.

Condition or disease Intervention/treatment Phase
Overactive Bladder Other: Acupuncture Other: Sham acupuncture Phase 2

Detailed Description:

This randomized, controlled trial is aimed to assess the effectiveness and safety of acupuncture in the treatment of overactive bladder (OAB) in adults. Eligible participants will be randomly allocated to acupuncture or sham acupuncture.

To minimize the evaluation bias, the outcome assessors and statisticians will be masked to treatment allocation besides participants.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Acupuncture for Overactive Bladder in Adults: A Random Control Clinical Trial
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arms and Interventions
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Arm Intervention/treatment
Experimental: Acupuncture
Participants will receive acupuncture.
 Other: Acupuncture
Participants will receive acupuncture, three times per week for eight weeks. The selected acupoints include bilateral BL33, BL35, SP6, and ST36. All acupoints areas have been sterilized before acupuncture. For BL33, a needle (Ф0.40×100mm) will be inserted with an angle of 60° in an inferomedial direction at a depth of 90-100mm. For BL35, the same needle will be inserted with a direction to the ischial rectal fossa at a depth of 60-70 mm deep. For SP6 and ST36, needles (Ф0.30×50mm) will be directly inserted at a depth of 25-30 mm deep. After the needles are inserted, a portable electro-acupuncture machine will be connected to the handles of needles located in BL33 and BL35 to provide the electrical stimulation for 30 minutes with a disperse-dense wave (4/20Hz). All current intensities will be as high as can be tolerated.
Sham Comparator: Sham acupuncture
Participants will receive sham acupuncture.
 Other: Sham acupuncture
The sham acupoints will be located at 20 mm outward to BL33, BL35, SP6, and ST36, and the needless will be inserted with a depth of 2 mm. The BL33 and BL35 will not receive any electrical stimulation, though the handles of needles will be connected to the same machine as the acupuncture group, and the parameter setting and course are also the same.


Outcome Measures
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Primary Outcome Measures :
  1. Change in number of micturition episodes per 24 hours [ Time Frame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) ]
    Assessed by 72 h bladder diary


Secondary Outcome Measures :
  1. Number of urinary urgency episodes per 24 hours [ Time Frame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) ]
    Assessed by 72 h bladder diary

  2. Number of daytime micturition episodes per 24 hours [ Time Frame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) ]
    Assessed by 72 h bladder diary

  3. Number of nocturia episodes per 24 hours [ Time Frame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) ]
    Assessed by 72 h bladder diary

  4. Change in mean volume voided per micturition [ Time Frame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) ]
    Assessed by 72 h bladder diary

  5. Change in OABSS questionnaire [ Time Frame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) ]
    Assessed by Overactive Bladder Symptom Score (OABSS) questionnaire. OABSS includes 4 questions about individual symptoms, and the total score ranged from 0 to 15, with higher scores indicating more severe symptoms. The minimal important difference (MID) for the OABSS is 3 points.

  6. Change in OAB-q SF questionnaire [ Time Frame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) ]
    Assessed by overactive bladder questionnaire short form (OAB-q SF) questionnaire. OAB-q SF includes 6 questions on 6-point Likert-type scales, with the outcomes transformed to a 0-100 point scale in which higher scores indicate more severe symptoms. The minimal important difference (MID) for the OAB-q SF is 11 points.

  7. Urinary NGF/Cr level [ Time Frame: Before treatment (baseline), 8 week (post-treatment) ]
    Measured by human nerve growth factor (NGF) ELISA Kit. NGF/Cr: NGF normalized to urine creatinine (Cr)

  8. Urinary BDNF/Cr level [ Time Frame: Before treatment (baseline), 8 week (post-treatment) ]
    Measured by human brain derived neurotrophic factor (BDNF) ELISA Kit. BDNF/Cr: BDNF normalized to urine creatinine (Cr)

  9. Urinary MCP-1/Cr level [ Time Frame: Before treatment (baseline), 8 week (post-treatment) ]
    Measured by human monocyte chemoattractant protein-1 (MCP-1) ELISA Kit. MCP-1/Cr: MCP-1 normalized to urine creatinine (Cr)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Present symptoms of urinary frequency and urgency for more than 3 months.
  • With a total score of more than 3 points on the overactive Bladder Symptom Score (OABSS) and a score of more than 2 points on question 3 of OABSS.

Exclusion Criteria:

  • With other lower urinary tract disorders (e.g. urinary tract infection, bladder outlet obstruction, neurogenic bladder, interstitial cystitis, etc.)
  • With previous pelvic floor surgery or a post-void residual urine volume more than 100 mL.
  • With neurological disease or psychiatric illness.
  • Taking medications affecting lower urinary tract function.
  • With contraindications to acupuncture.
  • Pregnant women.
Contacts and Locations
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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): NCT05158361


Contacts
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Contact: Ran Pang, MD +8610-88001040 pangran2002@sina.com

Locations
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China, Beijing
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
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Principal Investigator: Ran Pang, MD Guang'anmen hospital
More Information
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Responsible Party: Ran Pang, Professor, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT05158361    
Other Study ID Numbers: 2019S443
First Posted: December 15, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The agreement for sharing IPD is not designed to be signed in informed consent form.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ran Pang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Overactive Bladder
Acupuncture
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations