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临床试验/NCT06130306
NCT06130306已完成不适用

Electrical Pudendal Nerve Stimulation Versus Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation for Post-Radical Prostatectomy Incontinence: A Propensity Score Matching Analysis

Shanghai Institute of Acupuncture, Moxibustion and Meridian1 个研究点 分布在 1 个国家目标入组 389 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
389
试验地点
1
主要终点
International Consultation on Incontinence Questionnaire-short form score (ICIQ-SF)

研究概览

简要总结

The goal of this propensity score matching study is to compare the posttreatment outcomes of post-radical prostatectomy Incontinence patients undergoing either electrical pudendal nerve stimulation or pelvic floor muscle training combined with transanal electrical stimulation.

详细描述

Prostate cancer is the predominant form of cancer in older males. Radical prostatectomy (RP) is the sole treatment that enhances both overall survival and cancer-specific survival.Urinary incontinence remains a major morbidity associated with this procedure, greatly affecting patient satisfaction following RP. Extant research underscores the efficacy of pelvic floor muscle training (PFMT) in improving the strength and function of specific pelvic floor muscles, causing hypertrophy of peri-urethral striated muscles, thereby increasing the external mechanical pressure on the urethra. Another promising physiotherapy for post-radical prostatectomy incontinence (PPI) is electrical pudendal nerve stimulation (EPNS). An increasing body of research focuses on comparing continence restoration outcomes between PFMT and various electrical stimulations. However, such studies encompass cases with multiple pathological characteristics, and the reported data might not be considered representative or applicable to other populations due to overlooked confounding factors or selection bias. Thus, the investigators intend to conduct a propensity score matching (PSM) study aiming to compare the posttreatment outcomes of patients undergoing either EPNS or PFMT combined with TES, while ensuring a well-balanced control for confounding factor.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Onset of urinary incontinence at least 1 month post-RP
  • Minimum two documented incontinence episodes per week in a 7-day bladder diary
  • Pathological confirmation of no residual cancer post-RP

排除标准

  • High pathological risk factors (e.g., lymph node metastasis, resection margin involvement, bulky tumors)
  • Preoperative incontinence
  • Prior anticholinergic treatment
  • Urinary tract infection or hematuria
  • Postvoid residual volume exceeding 100 ml (determined by bladder ultrasound)
  • Neurological disorders
  • Urethral stricture

结局指标

主要结局

International Consultation on Incontinence Questionnaire-short form score (ICIQ-SF)

时间窗: T0 (baseline); T1 (day after 24th treatment); T2 (day after 36th treatment); T3 (day after 48th treatment); T4 (day after 60th treatment); T5 (day after 72nd treatment).

The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) is a validated and widely used questionnaire to assess and measure the impact of urinary incontinence on an individual's quality of life. This part includes a set of simple questions related to urinary incontinence symptoms, which the individual answers. The questions address the type and frequency of incontinence episodes, as well as their impact on daily life. The higher the score, the more severe the condition.

次要结局

  • Pad-counting Score(T0 (baseline); T1 (day after 24th treatment); T2 (day after 36th treatment); T3 (day after 48th treatment); T4 (day after 60th treatment); T5 (day after 72nd treatment).)

研究者

发起方
Shanghai Institute of Acupuncture, Moxibustion and Meridian
申办方类型
Other
责任方
Sponsor

研究点 (1)

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