跳至主要内容
临床试验/NCT05719220
NCT05719220招募中不适用

The Effect of Group Preoperative Pelvic Floor Training on Transient Urinary Incontinence After Holmium Laser Enucleation of the Prostate: A Prospective Cohort Study

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Incidence of urinary incontinence at 1 month

研究概览

简要总结

The main goal of this study is to see if group pelvic floor training before surgery can help prevent urinary incontinence after Holmium laser enucleation of the prostate (HoLEP) surgery. The study has the potential to inform preoperative intervention strategies for managing incontinence after HoLEP.

详细描述

Preoperative pelvic floor training (PFT) may improve early urinary incontinence after prostate surgery. Group-based training potentially provides additional benefits such as cost-benefit, social support, and motivation. However, the efficacy of group preoperative PFT has not been reported. This study aims to determine the effect of group preoperative PFT on transient urinary incontinence after HoLEP in a prospective cohort of patients and to identify any potential predictors of transient urinary incontinence after HoLEP.

In this study, the investigators will recruit approximately 50 patients in each cohort (total 100) and will be followed over time to collect data on both the exposure (group PFT) and the outcome (incidence of urinary incontinence 1 month and 3 months after HoLEP). Potential confounding variables, such as patient demographics, preoperative imaging, and operative data, will be collected and analyzed. The results of this study have the potential to inform the development of effective preoperative interventions for the management of transient urinary incontinence after HoLEP.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Consecutive patients with a diagnosis of BPH with a plan to undergo HoLEP.
  • Between the age of 50-
  • Ability to understand and provide informed consent.

排除标准

  • Patients whom inability to carry out PFT protocol.
  • Patients unwilling or unable to complete follow up care.
  • Severe urinary incontinence due to a history of neurological diseases such as a cerebrovascular accident or spinal cord injuries.
  • Patients whom inability to read and understand the English language.

结局指标

主要结局

Incidence of urinary incontinence at 1 month

时间窗: 1 month after the operation

Urinary incontinence (present/absent) will be defined according to the guidelines of the International Continence Society as involuntary loss of urine experienced during the bladder storage phase using self-report measures at regular intervals postoperatively.

Incidence of urinary incontinence at 3 months

时间窗: 3 months after the operation

Urinary incontinence (present/absent) will be defined according to the guidelines of the International Continence Society as involuntary loss of urine experienced during the bladder storage phase using self-report measures at regular intervals postoperatively.

次要结局

  • The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 1 month(1 month after the operation)
  • Pelvic floor muscle strength at 3 months(3 months after the operation)
  • Patient satisfaction(Immediately after the completion of the PFT program or soon thereafter)
  • The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 3 months(3 months after the operation)
  • The International Prostate Symptom Score at 1 month(1 month after the operation)
  • The International Prostate Symptom Score at 3 months(3 months after the operation)
  • Pelvic floor muscle strength at 1 month(1 month after the operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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