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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Uroflowmetry and questionnaires
  Uroflowmetry - urine flow assessment Questionnaires: IPSS, ICIQ-MLUTS, IIEF-5, MSHQ-EjD, EQ-5D-5L

Первичные конечные точки

• Change in maximal urine flow (Qmax) in uroflowmetry before and after RPLND surgery [Срок оценки: 6 months]
• Change in post-void residual volume (PVR) before and after RPLND surgery [Срок оценки: 6 months]
• Change in total IPSS score before and after RPLND surgery [Срок оценки: 6 months]
• Change in ICIQ-MLUTS score before and after RPLND surgery [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Change in IIEF-5 questionnaire before and after RPLND surgery [Срок оценки: 6 months]
• Change in MSHQ-EjD questionnaire before and after RPLND surgery [Срок оценки: 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

• History of RPLND
• Lack of consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Польша · 1 центр

• Jagiellonian University Medical College — Krakow

Идентификаторы

NCT: NCT06954233 · VEEF-RPLND-TC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗