Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 4:13 PM
Study NCT ID:
NCT06954233
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Voiding and Erectile Function After Retroperitoneal Lymph Node Dissection for Testicular Cancer
Sponsor:
Jagiellonian University
Organization:
Study Overview
Official Title:
Voiding, Erectile and Ejaculatory Function After Retroperitoneal Lymph Node Dissection for Testicular Cancer
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VEEF-RPLND-TC
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: