Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection for Urogenital Cancer (UroLymph)

  • STATUS
    Recruiting
  • End date
    Apr 11, 2024
  • participants needed
    30
  • sponsor
    Universitaire Ziekenhuizen Leuven
Updated on 11 March 2022

Summary

After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Lymphoedema is the result of a dysfunction in the lymphatic system and is characterized by excessive retention of lymphatic fluid in the interstitial compartment, adipose deposition and chronic tissue inflammation resulting in fibrosis. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function.

The added value of manual lymph drainage, applied in patients with mild (early) lower limb lymphoedema and in addition to skin care, exercises and a compression stocking, has never been investigated.

Therefore, the objective of this randomised controlled pilot trial is to investigate the feasibility of a trial about the added value of manual lymph drainage (to skin care, exercises and wearing compression stocking) in patients with mild (early) lower limb lymphoedema. In fact, the investigators want to determine the sample size for a trial investigating the effectiveness of MLD and want to investigate the feasibility of the study design.

Details
Condition Lower Limb Lymphedema, Urogenital Cancer
Treatment Usual Care, manual lymph drainage
Clinical Study IdentifierNCT05266157
SponsorUniversitaire Ziekenhuizen Leuven
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients included in the prospective observational study and developing lymphoedema within the first year after surgery
Before inclusion, written informed consent must be given according to ICH/GCP, and national/local regulations
Inclusion criteria of the prospective observational study were
Non-metastatic urogenital cancer (i.e. prostate cancer or bladder cancer)
Pelvic lymph node dissection

Exclusion Criteria

same as for the prospective observational study
Radiological evidence of metastatic disease based on pelvic CT/MRI and bone scan
Clinical signs of chronic venous insufficiency
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