Actively Recruiting
Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection for Urogenital Cancer: Prospective Observational Study
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-07-11
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the development of lower limb lymphoedema and urinary issues such as nocturia and nocturnal polyuria in patients treated for urogenital cancers like prostate and bladder cancer. This prospective observational study aims to determine how often these conditions occur after pelvic lymph node dissection surgery and to identify factors that may predict their development. The study also seeks to find the best clinical methods to detect early lymphoedema in the legs after treatment. The study involves 150 patients scheduled for transperitoneal pelvic lymph node dissection for urogenital cancer. Participants will be followed from before surgery until one year after surgery. All receive standard care including education about lymphoedema prevention, skincare routines, and supervised exercises to improve circulation, with frequency of therapy sessions decreasing over time. If lymphoedema develops, compression stockings will be provided. Evaluations occur at baseline, 6 weeks, 6 months, and 12 months post-surgery. During the study, participants will undergo clinical assessments for lymphoedema and urinary symptoms at scheduled visits. Researchers will track the incidence and prevalence of lymphoedema, as well as its detection methods, validity, and reliability. They will also study prognostic factors for lymphoedema and urinary conditions, monitoring changes over time. The study lasts up to two years, with participants enrolled during the first year and followed for one year after their surgery.
CONDITIONS
Brief Title
Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with non-metastatic urogenital cancer (prostate or bladder cancer)
- Planned transperitoneal pelvic lymph node dissection or salvage lymph node dissection
- Salvage lymph node dissection
- Provided written informed consent before inclusion according to regulations
You will not qualify if you...
- Radiological evidence of metastatic disease on pelvic CT/MRI and bone scan
- Clinical signs of chronic venous insufficiency (CEAP C3-C6)
- History of lymph node dissection or radiotherapy in the pelvis or groin area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From baseline (pre-surgery) until 12 months post-surgery
Participants undergoing transperitoneal pelvic lymph node dissection for urogenital cancer are observed for the development of lower limb lymphoedema and urinary issues such as nocturia and nocturnal polyuria. Clinical evaluations are performed to detect early signs and prognostic factors.
4 visits: baseline (pre-surgery), 6 weeks, 6 months, and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
University Hospitals Leuven, campus Gasthuisberg
Leuven, Flanders, Belgium, 3000
Actively Recruiting
Research Team
N
Nele Devoogdt, Prof. Dr.
C
Charlotte Van Calster, MSc.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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