Clinical trial NCT06954233: Voiding and Erectile Function After Retroperitoneal Lymph Node Dissection for Testictular Cancer
Official title: Voiding, Erectile and Ejaculatory Function After Retroperitoneal Lymph Node Dissection for Testicular Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Testicular Cancer
Keywords: Testicular Cancer
Retroperitoneal Lymph Node Dissection
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult males with testicular cancer undergoing retroperitoneal lymph node dissection (RPLND)

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* History of RPLND
* Lack of consent

Primary outcomes:
measure: Change in maximal urine flow (Qmax) in uroflowmetry before and after RPLND surgery
timeFrame: 6 months
measure: Change in post-void residual volume (PVR) before and after RPLND surgery
timeFrame: 6 months
measure: Change in total IPSS score before and after RPLND surgery
timeFrame: 6 months
measure: Change in ICIQ-MLUTS score before and after RPLND surgery
timeFrame: 6 months
Secondary outcomes:
measure: Change in IIEF-5 questionnaire before and ater RPLND surgery
timeFrame: 6 moths
measure: Change in MSHQ-EjD questionnaire before and ater RPLND surgery
timeFrame: 6 moths
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University Medical College
state: Malopolska
Study officials:
affiliation: Jagiellonian University
name: Anna K. Czech, M.D.
role: PRINCIPAL_INVESTIGATOR
References: