Voiding and Erectile Function After Retroperitoneal Lymph Node Dissection for Testicular Cancer (VEEF-RPLND-TC)

July 13, 2025 updated by: Anna K. Czech, MD, Jagiellonian University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Malopolska
      • Krakow, Malopolska, Poland, 30-688
        • Recruiting
        • Jagiellonian University Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • History of RPLND
  • Lack of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Uroflowmetry - urine flow assessment Questionnaires: IPSS, ICIQ-MLUTS, IIEF-5, MSHQ-EjD, EQ-5D-5L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in maximal urine flow (Qmax) in uroflowmetry before and after RPLND surgery
Time Frame: 6 months
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
Time Frame: 6 months
Change in post-void residual volume (PVR) before and after RPLND surgery
6 months
Change in total IPSS score before and after RPLND surgery
Time Frame: 6 months
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
Time Frame: 6 months
Patients will complete Incontinence Questionnaire - Male Lower Urinary Tract Symptoms - ICIQ-MLUTS questionnaire to assess urinary function before and after surgery
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in IIEF-5 questionnaire before and after RPLND surgery
Time Frame: 6 months
Patients will complete International Index of Erectile Function - IIEF-5 questionnaire before and after surgery to assess erectile function
6 months
Change in MSHQ-EjD questionnaire before and after RPLND surgery
Time Frame: 6 months
Patients will complete Male Sexual Health Questionnaire Ejaculatory Dysfunction - MSHQ-EjD questionnaire before and after surgery to assess erectile function
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Principal Investigator: Anna K. Czech, M.D., Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 13, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEEF-RPLND-TC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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