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

NCT06954233 | Recruiting

• 1 other identifier: VEEF-RPLND-TC
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Testicular Cancer

Keywords

Testicular Cancer; Retroperitoneal Lymph Node Dissection

Outcome Measures

Primary Outcomes (4)

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

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

  6 months

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

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

  6 months

• Change in total IPSS score before and after RPLND surgery

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

  6 months

• Change in ICIQ-MLUTS score before and after RPLND surgery

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

  6 months

Secondary Outcomes (2)

• Change in IIEF-5 questionnaire before and after RPLND surgery

  6 months

• Change in MSHQ-EjD questionnaire before and after RPLND surgery

  6 months

Study Arms (1)

Adult men with testicular cancer undergoing retroperitoneal lymph node dissection

Adult men with testicular cancer undergoing retroperitoneal lymph node dissection will have uroflowmetry performed and will complete questionnaires focusing on urinary, erectile and ejaculatory function before surgery, after surgery and during 6 months follow-up

Diagnostic Test: Uroflowmetry and questionnaires

Interventions

Uroflowmetry and questionnaires DIAGNOSTIC_TEST

Uroflowmetry - urine flow assessment Questionnaires: IPSS, ICIQ-MLUTS, IIEF-5, MSHQ-EjD, EQ-5D-5L

Adult men with testicular cancer undergoing retroperitoneal lymph node dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• History of RPLND
• Lack of consent

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College

Krakow, Malopolska, 30-688, Poland

RECRUITING

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Anna K. Czech, M.D.

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna K. Czech, M.D., Ph.D.

CONTACT

+48124002500; aka.czech@uj.edu.pl

Jakub Frydrych, M.D.

CONTACT

+48124002500; frydrych.jf@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 1, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

PL (1)