Acupuncture for Overactive Bladder in Adults
Primary Purpose
Overactive Bladder
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, Acupuncture
Eligibility 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.
Sites / Locations
- Guang'anmen Hospital, China Academy of Chinese Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Acupuncture
Sham acupuncture
Arm Description
Participants will receive acupuncture.
Participants will receive sham acupuncture.
Outcomes
Primary Outcome Measures
Change in number of micturition episodes per 24 hours
Assessed by 72 h bladder diary
Secondary Outcome Measures
Number of urinary urgency episodes per 24 hours
Assessed by 72 h bladder diary
Number of daytime micturition episodes per 24 hours
Assessed by 72 h bladder diary
Number of nocturia episodes per 24 hours
Assessed by 72 h bladder diary
Change in mean volume voided per micturition
Assessed by 72 h bladder diary
Change in OABSS questionnaire
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.
Change in OAB-q SF questionnaire
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.
Urinary NGF/Cr level
Measured by human nerve growth factor (NGF) ELISA Kit. NGF/Cr: NGF normalized to urine creatinine (Cr)
Urinary BDNF/Cr level
Measured by human brain derived neurotrophic factor (BDNF) ELISA Kit. BDNF/Cr: BDNF normalized to urine creatinine (Cr)
Urinary MCP-1/Cr level
Measured by human monocyte chemoattractant protein-1 (MCP-1) ELISA Kit. MCP-1/Cr: MCP-1 normalized to urine creatinine (Cr)
Full Information
NCT ID
NCT05158361
First Posted
December 2, 2021
Last Updated
March 21, 2023
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05158361
Brief Title
Acupuncture for Overactive Bladder in Adults
Official Title
Effectiveness and Safety of Acupuncture for Overactive Bladder in Adults: A Random Control Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the effectiveness and safety of acupuncture for treating overactive bladder in adults.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Participants will receive acupuncture.
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
Participants will receive sham acupuncture.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in number of micturition episodes per 24 hours
Description
Assessed by 72 h bladder diary
Time Frame
Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Secondary Outcome Measure Information:
Title
Number of urinary urgency episodes per 24 hours
Description
Assessed by 72 h bladder diary
Time Frame
Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Title
Number of daytime micturition episodes per 24 hours
Description
Assessed by 72 h bladder diary
Time Frame
Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Title
Number of nocturia episodes per 24 hours
Description
Assessed by 72 h bladder diary
Time Frame
Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Title
Change in mean volume voided per micturition
Description
Assessed by 72 h bladder diary
Time Frame
Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Title
Change in OABSS questionnaire
Description
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.
Time Frame
Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Title
Change in OAB-q SF questionnaire
Description
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.
Time Frame
Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Title
Urinary NGF/Cr level
Description
Measured by human nerve growth factor (NGF) ELISA Kit. NGF/Cr: NGF normalized to urine creatinine (Cr)
Time Frame
Before treatment (baseline), 8 week (post-treatment)
Title
Urinary BDNF/Cr level
Description
Measured by human brain derived neurotrophic factor (BDNF) ELISA Kit. BDNF/Cr: BDNF normalized to urine creatinine (Cr)
Time Frame
Before treatment (baseline), 8 week (post-treatment)
Title
Urinary MCP-1/Cr level
Description
Measured by human monocyte chemoattractant protein-1 (MCP-1) ELISA Kit. MCP-1/Cr: MCP-1 normalized to urine creatinine (Cr)
Time Frame
Before treatment (baseline), 8 week (post-treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Pang, MD
Phone
+8610-88001040
Email
pangran2002@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ran Pang, MD
Organizational Affiliation
Guang'anmen hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Pang, MD
Phone
+8610-88001040
Email
pangran2002@sina.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The agreement for sharing IPD is not designed to be signed in informed consent form.
Citations:
PubMed Identifier
36148895
Citation
Hargreaves E, Baker K, Barry G, Harding C, Zhang Y, Kandala NB, Zhang X, Kernohan A, Clarkson CE. Acupuncture for treating overactive bladder in adults. Cochrane Database Syst Rev. 2022 Sep 23;9(9):CD013519. doi: 10.1002/14651858.CD013519.pub2.
Results Reference
derived
Learn more about this trial
Acupuncture for Overactive Bladder in Adults
We'll reach out to this number within 24 hrs