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NCT Number: NCT06954233

Voiding and Erectile 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Jagiellonian University Medical College

Krakow, Malopolska, 30-688, Poland

Location status: Recruiting

Location contact

Anna K. Czech, M.D.

CONTACT

[email protected]

+48124002500

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of RPLND
  • Lack of consent

Treatment and study plan

Uroflowmetry and questionnaires

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+48124002500

Jakub Frydrych, M.D.

CONTACT

[email protected]

+48124002500

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Acronym: VEEF-RPLND-TC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 1, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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