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Recruiting NCT06954233

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

Observational Testicular Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Uroflowmetry and questionnaires.
Who it may be relevant to
Registry conditions: Testicular Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Change in maximal urine flow (Qmax) in uroflowmetry before and after RPLND surgery [Time frame: 6 months]
  • Change in post-void residual volume (PVR) before and after RPLND surgery [Time frame: 6 months]
  • Change in total IPSS score before and after RPLND surgery [Time frame: 6 months]
  • Change in ICIQ-MLUTS score before and after RPLND surgery [Time frame: 6 months]
Secondary outcome measures (2)
  • Change in IIEF-5 questionnaire before and after RPLND surgery [Time frame: 6 months]
  • Change in MSHQ-EjD questionnaire before and after RPLND surgery [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • History of RPLND
  • Lack of consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • Jagiellonian University Medical College — Krakow

Identifiers

NCT: NCT06954233 · VEEF-RPLND-TC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗