Background: Overactive bladder (OAB) is a prevalent condition that substantially degrades patient quality of life. Acupuncture is recognized as an effective therapeutic approach for various urological diseases. However, there is limited evidence validating the effectiveness and safety of acupuncture for OABs. Objective: To assess the therapeutic efficacy of acupuncture for OAB and to investigate the potential mechanisms by analyzing its effects on relevant urinary biomarkers. Methods: This is a randomized, participants and outcome assessors blinded, sham acupuncture controlled trial. A total of 110 patients with OABs will be randomly divided in a 1:1 ratio between the acupuncture and sham acupuncture groups. Participants in the acupuncture group will undergo 30-min authentic acupuncture, while their counterparts in the sham acupuncture group will undergo sham acupuncture needling non-acupoints superficially three times weekly for a duration of 8 weeks. The two co-primary outcomes will be the change in the mean number of micturitions per 24 h from baseline to the end of the 8-week treatment and 20-week follow-up. The secondary outcomes will encompass the change in Overactive Bladder Symptom Score, Overactive Bladder Questionnaire Short Form, and average 24 h values of urgency, daytime micturition, nocturia, and mean volume voided per micturition from baseline to weeks 8 and 20. Urinary nerve growth factor, brain-derived neurotrophic factor, and monocyte chemoattractant protein-1 levels will be measured at baseline and week 8. Adverse events will also be documented. Discussion The results of this trial will provide evidence for the effectiveness and safety of acupuncture in the management of OAB.

It is believed that the endoscopic manifestations of interstitial cystitis/bladder pain syndrome （IC/BPS） such as extensive bleeding and Hunner's ulcers as well as its recurrent and prolonged condition are in line with the characteristics of sores and ulcers in traditional Chinese medicine （TCM）， and the treatment can be referred to TCM theory of sores and ulcers. The mechanism of IC/BPS is characterized by root deficiency and branch excess. The root cause is deficiency of the spleen and kidney qi， while the manifesting factors are dampness-heat and blood stasis. The treatment is based on the principles of promoting and supplementing， combining with resolving therapy， so that the symptoms could be relieved by promoting blood circulation and clearing heat， unblocking the collaterals and relieve pain. In clinical practice， modified Neituo Shengji Powder （内托生肌散） was commonly used to boost qi and invigorate blood， expel swollen sore and express toxin； combining with Sijunzi Decoction （四君子汤） or Suoquan Pill （缩泉丸） based on specific symptoms to strengthen the spleen and kidneys， thereby reinforcing healthy qi； according to concurrent symptoms like blood stasis， dampness heat， prescription with Sanleng （Cyperus rotundus）， Ezhu （Curcuma aromatica Salisb） to invigorate blood and dissolve stasis， or Yiyiren （Coix lacryma-jobi）， Zexie （Alisma plantago-aquatica） to clear heat and drain dampness.