Testicular CancerVEEF-RPLND-TCNCT06954233
Voiding and Erectile Function After Retroperitoneal Lymph Node Dissection for Testicular Cancer
An observational study of Testicular Cancer, run by Jagiellonian University at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Uroflowmetry and questionnaires
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 14 May 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult males with testicular cancer undergoing retroperitoneal lymph node dissection (RPLND)
Who may be able to join
- Adult male with testicular cancer undergoing retroperitoneal lymph node dissection (RPLND)
Who cannot join
- History of RPLND
- Lack of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian University Medical College
Krakow, Malopolska, 30-688
Anna K. Czech, M.D., +48124002500, aka.czech@uj.edu.pl
About this study
Official title: 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.
Read the 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.
- Conditions
- Testicular Cancer
- Being tested
- Uroflowmetry and questionnaires
- Keywords
- Testicular Cancer, Retroperitoneal Lymph Node Dissection
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uroflowmetry and questionnairesDiagnostic test
Uroflowmetry - urine flow assessment Questionnaires: IPSS, ICIQ-MLUTS, IIEF-5, MSHQ-EjD, EQ-5D-5L
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Uroflowmetry and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal urine flow (Qmax) in uroflowmetry before and after RPLND surgery
Change in maximal urine flow (Qmax) in uroflowmetry before and after RPLND surgery
Measured: 6 months
Change in post-void residual volume (PVR) before and after RPLND surgery
Change in post-void residual volume (PVR) before and after RPLND surgery
Measured: 6 months
Change in total IPSS score before and after RPLND surgery
Patients will complete International Prostate Symptom Score (IPSS) questionnaire to assess urinary function before and after surgery
Measured: 6 months
Change in ICIQ-MLUTS score before and after RPLND surgery
Patients will complete Incontinence Questionnaire - Male Lower Urinary Tract Symptoms - ICIQ-MLUTS questionnaire to assess urinary function before and after surgery
Measured: 6 months
Secondary outcomes (2)
Change in IIEF-5 questionnaire before and after RPLND surgery
Patients will complete International Index of Erectile Function - IIEF-5 questionnaire before and after surgery to assess erectile function
Measured: 6 months
Change in MSHQ-EjD questionnaire before and after RPLND surgery
Patients will complete Male Sexual Health Questionnaire Ejaculatory Dysfunction - MSHQ-EjD questionnaire before and after surgery to assess erectile function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start14 May 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna K. Czech, MD, Jagiellonian University
- Investigators
- Anna K. Czech, M.D., Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954233
- Sponsor's protocol ID
- VEEF-RPLND-TC
- Acronym
- VEEF-RPLND-TC
- Status last verified
- Jul 2025
- First submitted
- 24 Apr 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voiding, Erectile and Ejaculatory Function After Retroperitoneal Lymph Node Dissection for Testicular Cancer
- ClinicalTrials.gov ID
- NCT06954233
- Acronym / sponsor ID
- VEEF-RPLND-TC / VEEF-RPLND-TC
- Conditions
- Testicular Cancer
- Keywords
- Testicular Cancer, Retroperitoneal Lymph Node Dissection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult men with testicular cancer undergoing retroperitoneal lymph node dissection | – | Diagnostic Test: Uroflowmetry and questionnairesAdult 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult males with testicular cancer undergoing retroperitoneal lymph node dissection (RPLND)
Key inclusion criteria (1 listed)
- Adult male with testicular cancer undergoing retroperitoneal lymph node dissection (RPLND)
Key exclusion criteria (2 listed)
- History of RPLND
- Lack of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uroflowmetry and questionnairesUroflowmetry - urine flow assessment Questionnaires: IPSS, ICIQ-MLUTS, IIEF-5, MSHQ-EjD, EQ-5D-5L | Diagnostic test | Adult men with testicular cancer undergoing retroperitoneal lymph node dissection |
Primary outcome
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
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
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
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
2 secondary outcomes
Change in IIEF-5 questionnaire before and after RPLND surgery
Time frame: 6 months
Change in MSHQ-EjD questionnaire before and after RPLND surgery
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna K. Czech, M.D. principal investigator
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Cancer, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna K. Czech, M.D., Ph.D. (+48124002500, aka.czech@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximal urine flow (Qmax) in uroflowmetry before and after RPLND surgery (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025; AzTrials last refreshed its copy on 28 Oct 2026.