Acupuncture for Overactive Bladder in Adults
- Conditions
- Overactive Bladder
- Interventions
- Other: Sham acupunctureOther: Acupuncture
- Registration Number
- NCT05158361
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham acupuncture Sham acupuncture Participants will receive sham acupuncture. Acupuncture Acupuncture Participants will receive acupuncture.
- Primary Outcome Measures
Name Time Method Change in number of micturition episodes per 24 hours Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) Assessed by 72 h bladder diary
- Secondary Outcome Measures
Name Time Method Change in mean volume voided per micturition Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) Assessed by 72 h bladder diary
Number of daytime micturition episodes per 24 hours Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) Assessed by 72 h bladder diary
Urinary MCP-1/Cr level 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)
Change in OAB-q SF questionnaire 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.
Urinary NGF/Cr level Before treatment (baseline), 8 week (post-treatment) Measured by human nerve growth factor (NGF) ELISA Kit. NGF/Cr: NGF normalized to urine creatinine (Cr)
Number of nocturia episodes per 24 hours Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) Assessed by 72 h bladder diary
Urinary BDNF/Cr level 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)
Number of urinary urgency episodes per 24 hours Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up) Assessed by 72 h bladder diary
Change in OABSS questionnaire 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.
Trial Locations
- Locations (1)
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China