Acupuncture for Overactive Bladder in Adults

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05158361
• Other study ID #: 2019S443
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Ran Pang, MD
• Phone: +8610-88001040
• Email: pangran2002[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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 (?0.40×100mm) 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 (?0.30×50mm) 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 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.

Locations

Country	Name	City	State
China	Guang'anmen Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)