Clinical trial NCT05158361: 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
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Acupuncture
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in number of micturition episodes per 24 hours
timeFrame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
Secondary outcomes:
measure: Number of urinary urgency episodes per 24 hours
timeFrame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
measure: Number of daytime micturition episodes per 24 hours
timeFrame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
measure: Number of nocturia episodes per 24 hours
timeFrame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
measure: Change in mean volume voided per micturition
timeFrame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
measure: Change in OABSS questionnaire
timeFrame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
measure: Change in OAB-q SF questionnaire
timeFrame: Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)
measure: Urinary NGF/Cr level
timeFrame: Before treatment (baseline), 8 week (post-treatment)
measure: Urinary BDNF/Cr level
timeFrame: Before treatment (baseline), 8 week (post-treatment)
measure: Urinary MCP-1/Cr level
timeFrame: Before treatment (baseline), 8 week (post-treatment)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'anmen hospital
name: Ran Pang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.