跳至主要内容
临床试验/NCT04924218
NCT04924218已完成不适用

The Effect of Endoscopic Procedures After Radical Prostatectomy on Urinary Incontinence

Ankara Yildirim Beyazıt University2 个研究点 分布在 2 个国家目标入组 18 人开始时间: 2020年11月15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
18
试验地点
2
主要终点
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)

研究概览

简要总结

The researchers investigated whether endoscopic retrograde urethral interventions applied for various reasons after radical prostatectomy (RP) operation cause a change in urinary incontinence (UI) level, and if there is a change, whether it changes according to the endoscopic procedure time and the endoscopic instrument used.

详细描述

Localized prostate cancer is usually treated with RP. The most common complications after RP are erectile dysfunction (ED) and UI. After RP, some patients may require retrograde endoscopic urethral intervention. In this study, researchers investigated whether there is a change in the UI level in patients that underwent retrograde urethral intervention after RP and whether this change was affected by the duration of the procedure and type of endoscopic device used.

Methods: Eighteen patients were included in the study. The patients were divided into 3 groups based on the endoscopic device used: group 1 rigid cystoscopy, group 2 flexible cystoscopy, and group 3 semi-rigid ureterorenoscopy (URS). The Turkish version of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) and the number of pads used daily was questioned before the endoscopic procedure and 1 month after the procedure.

研究设计

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

入排标准

年龄范围
52 Years 至 84 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients who have undergone radical prostatectomy
  • Patients that had undergone an endoscopic procedure 1 year after RP

排除标准

  • Patients with urinary tract infection before the endoscopic procedure,
  • Urinary tract infection at 1st month follow-up
  • Central neurological deficit
  • History of adjuvant radiotherapy after RP
  • Bladder neck stenosis and urethral stenosis
  • Patients that had undergone endoscopic urethral intervention before this scheduled procedure
  • Patients who had a double J stent inserted during the endoscopic procedure and required a second endoscopic intervention
  • Patients that required the use of bipolar or monopolar cautery

结局指标

主要结局

International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)

时间窗: 1 month

The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. Minimum score: 0, maximum score: 21. The higher the score, the higher the level of urinary incontinence is interpreted.

Daily pad use

时间窗: 1 month

It refers to the number of pads used in 1 day due to urinary incontinence.

次要结局

未报告次要终点

研究者

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

selman unal

Principal Investigator

Ankara Yildirim Beyazıt University

研究点 (2)

Loading locations...

相似试验