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临床试验/NCT07534696
NCT07534696Enrolling By Invitation不适用

Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2026年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
37
试验地点
1
主要终点
Change in EPIC questionnaire score

研究概览

简要总结

Urinary incontinence is a common complication following prostatectomy and affects a substantial proportion of patients. Despite advances in surgical technique, many patients experience persistent symptoms that negatively impact quality of life. Current management strategies include pelvic floor muscle training, biofeedback and physical therapy, and surgical options. However, these approaches may be limited by adherence, access, and invasiveness, leaving a subset of patients with ongoing symptoms despite standard care.

Non-invasive pelvic floor neuromuscular stimulation has emerged as a potential adjunct for pelvic floor rehabilitation by inducing supramaximal muscle contractions and enhancing neuromuscular activation without requiring active patient effort. Preliminary studies suggest that high-intensity electromagnetic stimulation may improve patient-reported continence outcomes and pad usage in women as well as men following radical prostatectomy, though existing data are limited by small sample sizes and short follow-up durations. Additionally, no clinical studies exist evaluating outcomes in men following prostatectomy prior to established stress incontinence.

Given these limitations, further evaluation is needed to assess the feasibility, tolerability, and short-term effectiveness of this intervention in a post-prostatectomy population.

详细描述

This prospective study aims to evaluate feasibility, safety, and patient-reported continence outcomes associated with non-invasive pelvic floor neuromuscular stimulation in men with urinary incontinence following prostatectomy. Findings may inform future clinical implementation and guide the design of larger, controlled trials.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Men aged 18 years or older
  • Undergoing or underwent prostatectomy at UCLA
  • Able to provide informed consent

排除标准

  • Cardiac pacemaker, implanted defibrillator, or other contraindicated metallic or electronic implants
  • Active urinary tract infection
  • Hematuria of unknown origin
  • Untreated bladder outlet obstruction
  • Neurologic conditions affecting bladder function (e.g., multiple sclerosis, Parkinson disease, spinal cord injury)
  • Active fever or systemic inflammatory condition at the time of treatment
  • Any condition deemed by the investigator to make participation unsafe

研究组 & 干预措施

Non-invasive pelvic floor neuromuscular stimulation

Experimental

Participants will complete an 8-week intervention (12 sessions total) of non-invasive pelvic floor neuromuscular stimulation, with outcomes assessed at baseline, end of treatment, and follow-up within three months of starting the intervention.

干预措施: Non-invasive pelvic floor neuromuscular stimulation (Device)

结局指标

主要结局

Change in EPIC questionnaire score

时间窗: From enrollment to 3 months after initiation of treatment

The Expanded Prostate Cancer Index Composite (EPIC) is a validated questionnaire assessing urinary, bowel, sexual, and hormonal outcomes.

Change in ICIQ-UI questionnaire score

时间窗: From enrollment to 3 months after initiation of treatment

The International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI) short form is a validated questionnaire assessing urinary incontinence.

Continence

时间窗: From enrollment to 3 months after initiation of treatment

Continence is measured by number of pads used per 24 hours, with continence defined as less than one pad used per day.

次要结局

  • Treatment failure(From enrollment to 3 months after initiation of treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jesse N. Mills, MD

Clinical Professor of Urology

University of California, Los Angeles

研究点 (1)

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