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

NCT ID: NCT06954233

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-14

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Testicular Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Uroflowmetry and questionnaires

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Uroflowmetry and questionnaires

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* History of RPLND
* Lack of consent
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Anna K. Czech, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna K. Czech, M.D.

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Locations

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Jagiellonian University Medical College

Krakow, Malopolska, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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

Role: CONTACT

+48124002500

Jakub Frydrych, M.D.

Role: CONTACT

+48124002500

Facility Contacts

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Anna K. Czech, M.D.

Role: primary

+48124002500

Other Identifiers

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VEEF-RPLND-TC

Identifier Type: -

Identifier Source: org_study_id

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