Electroacupuncture in Patients With Early Urinary Incontinence After Radical Prostatectomy: A Randomized Clinical Trial

电针疗法治疗根治性前列腺切除术后早期尿失禁患者:一项随机临床试验

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Abstract

IMPORTANCE: Postprostatectomy urinary incontinence (UI) impairs quality of life, yet effective noninvasive therapies remain limited. OBJECTIVE: To investigate the efficacy and safety of electroacupuncture in patients with early UI after radical prostatectomy (RP). DESIGN, SETTING, AND PARTICIPANTS: This prospective, single-center, randomized, single-blinded clinical trial was conducted at Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, from July 23, 2021, to November 1, 2024, with 20-week follow-up completed March 24, 2025. Men with localized prostate cancer who underwent robot-assisted RP and experienced UI (defined as use of ≥2 pads per day) 4 to 6 weeks postoperatively were consecutively enrolled and randomly assigned 1:1 to the electroacupuncture or sham stimulation group. Patients with any prior neoadjuvant hormonal therapy, any prior prostatic surgery, any history of pelvic surgery, and history of UI before RP were excluded. Three participants withdrew before the intervention, and 101 (91.8%) completed follow-up. Intention-to-treat analysis was used. INTERVENTIONS: Patients in the electroacupuncture group received electroacupuncture administered at bilateral Ciliao, Zhongliao, and Xialiao acupoints, with sparse-dense wave electrostimulation (alternating between 2 and 15 Hz) for 30 minutes per session, 3 times per week for 6 weeks. The sham stimulation group underwent identical procedures with nonpuncturing flat-tip needles at offset points. MAIN OUTCOMES AND MEASURES: The primary outcome was urinary continence (UC), defined as the use of 0 to 1 pad per day 6 weeks after the first electroacupuncture session. RESULTS: A total of 110 men (median age, 69 [IQR, 67-72] years) were randomized. At week 6, the intention-to-treat analysis showed that the electroacupuncture group achieved a significantly higher UC rate than the sham stimulation group (24 of 55 [43.6%] vs 12 of 55 [21.8%]; relative risk, 2.00; 95% CI, 1.12-3.59; P = .02). CONCLUSIONS AND RELEVANCE: The findings of this randomized clinical trial show that electroacupuncture significantly accelerated postprostatectomy UC recovery and may serve as a safe adjunct to standard care. These findings support integrating electroacupuncture into multimodal rehabilitation protocols to reduce early UI burden. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04972669.

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