Acupuncture for Overactive Bladder in Adults

Effectiveness and Safety of Acupuncture for Overactive Bladder in Adults: A Random Control Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder
• Intervention / Treatment: Other: Acupuncture; Other: Sham acupuncture

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ran Pang, MD; Phone Number: +8610-88001040; Email: pangran2002@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
      • Contact: Ran Pang, MD; Phone Number: +8610-88001040; Email: pangran2002@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of micturition episodes per 24 hours	Assessed by 72 h bladder diary	Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of urinary urgency episodes per 24 hours	Assessed by 72 h bladder diary	Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Number of daytime micturition episodes per 24 hours	Assessed by 72 h bladder diary	Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Number of nocturia episodes per 24 hours	Assessed by 72 h bladder diary	Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Change in mean volume voided per micturition	Assessed by 72 h bladder diary	Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
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.	Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
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.	Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Urinary NGF/Cr level	Measured by human nerve growth factor (NGF) ELISA Kit. NGF/Cr: NGF normalized to urine creatinine (Cr)	Before treatment (baseline), 8 week (post-treatment)
Urinary BDNF/Cr level	Measured by human brain derived neurotrophic factor (BDNF) ELISA Kit. BDNF/Cr: BDNF normalized to urine creatinine (Cr)	Before treatment (baseline), 8 week (post-treatment)
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)	Before treatment (baseline), 8 week (post-treatment)

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Ran Pang, MD, Guang'anmen hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Acupuncture; Overactive Bladder
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: 2019S443

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The agreement for sharing IPD is not designed to be signed in informed consent form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No