Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China.
Clinical Research Section, Shanghai Research Institute of Acupuncture and Meridian, Shanghai Yueyang Hospital, Shanghai, China.
BMJ Open. 2023 Jan 5;13(1):e062323. doi: 10.1136/bmjopen-2022-062323.
Urinary incontinence (UI) is one of the main complications of radical prostatectomy. Electrical pudendal nerve stimulation (EPNS) has been used to treat stress UI based on its mechanism of passive pelvic floor muscle contraction reported in the previous research. However, there are no studies comparing the effects of EPNS and active pelvic floor muscle training (PFMT) in the treatment of postradical prostatectomy UI (PPUI). Here, we describe the protocol for a randomised controlled trial to evaluate the efficacy of EPNS in treating PPUI compared with PFMT.
This study is designed as an open-label randomised controlled trial with blinded assessment and analysis. A total of 90 eligible men will be randomly allocated to two groups. The treatment group (n=45) will receive EPNS while the control group will perform PFMT by doing the Kegel exercise. Forty EPNS treatment sessions will occur over a period of 8 weeks. The primary outcome measure will be improvement rate, and the secondary outcome measures, the number of pads used, 24-hour pad test, and International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form will be compared between baseline and the study endpoint. The International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life and care compared as the quality of life and satisfaction outcomes between groups.
This protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval no. 2021 KL-040-02). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.
ChiCTR2200055461.
尿失禁（UI）是根治性前列腺切除术的主要并发症之一。电阴部神经刺激（EPNS）已被用于治疗压力性 UI，其机制是基于先前研究报道的被动盆底肌肉收缩。然而，目前尚无研究比较 EPNS 和主动盆底肌肉训练（PFMT）治疗根治性前列腺切除术后尿失禁（PPUI）的效果。在这里，我们描述了一项随机对照试验的方案，以评估 EPNS 治疗 PPUI 的疗效与 PFMT 相比。
本研究设计为开放性标签随机对照试验，采用盲法评估和分析。共有 90 名符合条件的男性将被随机分配到两组。治疗组（n=45）将接受 EPNS，而对照组将通过进行凯格尔运动进行 PFMT。40 次 EPNS 治疗疗程将在 8 周内进行。主要结局指标为改善率，次要结局指标为使用的尿垫数量、24 小时尿垫试验和国际尿失禁咨询问卷-尿失禁简短问卷，将在基线和研究终点之间进行比较。国际尿失禁咨询问卷-下尿路症状生活质量和护理将作为组间生活质量和满意度的结果进行比较。
本方案已获得浙江中医药大学第一附属医院伦理委员会的批准（批准号：2021KL-040-02）。将从每位参与者处获得书面知情同意书。研究结果将发表在同行评议的期刊上。
ChiCTR2200055461。
