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临床试验/NCT07719036
NCT07719036进行中(未招募)不适用

Evaluation of the Effect of Pelvic Muscle Exercises on Urinary Incontinence in Patients Undergoing HoLEP Surgery: A Randomized Controlled Trial.

Atlas University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
20
试验地点
1
主要终点
Urinary incontinence severity index

研究概览

简要总结

Patients meeting the eligibility criteria and scheduled for HoLEP surgery will provide written informed consent prior to enrollment. Participants will be randomly assigned to either the intervention or control group. Upon acceptance, baseline demographic and clinical data will be collected. In the intervention group, standardized pelvic floor muscle training (PFMT) will be administered individually the day before surgery. Participants will be instructed to perform slow and rapid pelvic floor muscle contractions. The same supervised exercise protocol will be repeated on days 1 and 2 post-surgery. After discharge, participants will be contacted weekly during the first month and monthly during the second and third months to encourage adherence to PFMT. At the end of the third month post-surgery, urinary incontinence will be assessed using the Severity Index of Urinary Incontinence (ISI) and the International Urinary Incontinence Advisory Questionnaire - Short Form (ICIQ-SF). The control group will receive routine pre- and post-operative care without supervised PFMT and will undergo the same outcome assessments at the third month post-surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have undergone HOLEP surgery, who can speak and understand Turkish, Patients without visual, hearing, speech, or mental problems.

排除标准

  • Patients who develop postoperative complications

结局指标

主要结局

Urinary incontinence severity index

时间窗: Weekly during the first month after discharge, and once each month during the 2nd and 3rd months.

The severity of incontinence in individuals was assessed using the Urinary Incontinence Severity Index (ISI). This index consists of 2 items. The first item questions the frequency of urinary incontinence, and the second item questions the amount of urine leaked. The total score is obtained by multiplying the scores from the first and second items and ranges from 1 to 12. A higher score indicates more severe urinary incontinence. The studies conducted show that ISI is a valid measure in assessing the severity of incontinence.

次要结局

  • International Urinary Incontinence Questionnaire-Short Form (ICIQ SF)(Patients are contacted weekly during the first month after discharge, and once each month during the 2nd and 3rd months.)

研究者

发起方
Atlas University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cagla Toprak

Dr.

Atlas University

研究点 (1)

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