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临床试验/NCT06954233
NCT06954233招募中不适用

Voiding, Erectile and Ejaculatory Function After Retroperitoneal Lymph Node Dissection for Testicular Cancer

Jagiellonian University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Change in maximal urine flow (Qmax) in uroflowmetry before and after RPLND surgery

研究概览

简要总结

This study aims to evaluate how retroperitoneal lymph node dissection (RPLND), a surgical treatment for testicular cancer, may affect urinary and sexual functions in men. RPLND involves the removal of lymph nodes from the abdominal area and is sometimes necessary in patients who are not eligible for chemotherapy or who have residual disease after chemotherapy. While this surgery is known to carry a risk of affecting ejaculation, its potential impact on other areas such as urination or erection is not well understood.

The study will prospectively follow adult men undergoing RPLND. It will assess changes in lower urinary tract symptoms, urine flow, ejaculation, erection, and overall quality of life before surgery and during follow-up visits up to 6 months after the operation. Patients will complete standardized questionnaires and undergo simple, non-invasive tests such as urine flow measurement.

By identifying how RPLND may influence urinary and sexual health, this study seeks to improve understanding of the full range of effects of this treatment. The findings may help clinicians better inform patients before surgery and support improved post-operative care.

详细描述

This is a prospective observational study designed to evaluate the impact of retroperitoneal lymph node dissection (RPLND) on lower urinary tract and sexual function in patients treated for testicular cancer. The study incorporates validated patient-reported outcome measures (PROMs) alongside objective functional assessments to characterize post-RPLND urinary and sexual sequelae over time.

Patients will complete standardized questionnaires preoperatively and at scheduled postoperative intervals, including the International Prostate Symptom Score (IPSS), International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS), International Index of Erectile Function (IIEF-5), Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD), and EQ-5D-5L for health-related quality of life. Objective evaluation will include uroflowmetry and ultrasound-based measurement of post-void residual volume.

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

入选标准

  • Adult male with testicular cancer undergoing retroperitoneal lymph node dissection (RPLND)

排除标准

  • History of RPLND
  • Lack of consent

结局指标

主要结局

Change in maximal urine flow (Qmax) in uroflowmetry before and after RPLND surgery

时间窗: 6 months

Change in maximal urine flow (Qmax) in uroflowmetry before and after RPLND surgery

Change in post-void residual volume (PVR) before and after RPLND surgery

时间窗: 6 months

Change in post-void residual volume (PVR) before and after RPLND surgery

Change in total IPSS score before and after RPLND surgery

时间窗: 6 months

Patients will complete International Prostate Symptom Score (IPSS) questionnaire to assess urinary function before and after surgery

Change in ICIQ-MLUTS score before and after RPLND surgery

时间窗: 6 months

Patients will complete Incontinence Questionnaire - Male Lower Urinary Tract Symptoms - ICIQ-MLUTS questionnaire to assess urinary function before and after surgery

次要结局

  • Change in IIEF-5 questionnaire before and after RPLND surgery(6 months)
  • Change in MSHQ-EjD questionnaire before and after RPLND surgery(6 months)

研究者

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

Anna K. Czech, MD

Principal Investigator

Jagiellonian University

研究点 (1)

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