Actively Recruiting

Age: 18Years +
All Genders
NCT05300308

Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-07-11

150

Participants Needed

1

Research Sites

249 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function. Lymphoedema can have a negative impact on quality of life (QoL) and the impact of lymphoedema on the cancer treatment decision making process is underestimated. A limited number of studies have evaluated the incidence rate of midline and leg lymphoedema after surgery for urogenital cancers and have investigated the prognostic variables. In addition, to the researchers knowledge, no evidence exists regarding which (combination of) clinical measuring methods are most sensitive to detect early lymphoedema at the lower limbs after the treatment of urogenital cancer. Therefore, in this prospective observational study, the epidemiology (i.e. incidence/ prevalence rate and prognostic variables) and the detection methods of lower limb lymphoedema after pelvic lymph node dissection for urogenital cancer will be investigated. Additionally, the epidemiology of nocturia and nocturnal polyuria will be studied (since this information is also missing in literature).

CONDITIONS

Official Title

Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of non-metastatic urogenital cancer (prostate or bladder cancer)
  • Planned transperitoneal pelvic lymph node dissection or salvage lymph node dissection
  • Signed written informed consent following regulations
Not Eligible

You will not qualify if you...

  • Presence of metastatic disease seen on pelvic CT/MRI or bone scan
  • Clinical signs of chronic venous insufficiency classified as CEAP C3 to C6
  • Previous 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

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Trial Site Locations

Total: 1 location

1

University Hospitals Leuven, campus Gasthuisberg

Leuven, Flanders, Belgium, 3000

Actively Recruiting

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Research Team

N

Nele Devoogdt, Prof. Dr.

CONTACT

C

Charlotte Van Calster, MSc.

CONTACT

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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