Clinical trial · Observational
Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer
Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND): Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lower Limb Lymphedema | — | UNRESOLVED | — |
| Nocturia | — | UNRESOLVED | — |
| Nocturnal Polyuria | — | UNRESOLVED | — |
| Urogenital Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- transperitoneal pelvic lymph node dissection for treatment of urogenital cancer
- description
- patients planned for transperitoneal pelvic lymph node dissection for treatment of urogenital cancer (including prostate or bladder cancer)
- interventionNames
- Other: usual care
Primary outcomes (16)
- measure
- Cumulative incidence rate of lower limb lymphoedema after urogenital cancer (i.e. number of patients with newly diagnosed lower limb lymphoedema) 6 weeks post-surgery
- timeFrame
- 6 weeks post-surgery
- description
- Calculation of the proportion of patients who developed leg lymphoedema during a certain time interval (defined as 5.0% or more increase of the leg volume) and calculation of the proportion of patients who developed midline lymphoedema during a certain time interval (defined as 20% or more increase of the baseline water content at the prepubic region)
- measure
- Cumulative incidence rate of lower limb lymphoedema after urogenital cancer (i.e. number of patients with newly diagnosed lower limb lymphoedema) 6 months post-surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non-metastatic urogenital cancer (i.e. prostate cancer or bladder cancer) * Planned transperitoneal pelvic lymph node dissection or salvage lymph node dissection * Salvage lymph node dissection * Before inclusion, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: * Radiological evidence of metastatic disease based on pelvic CT/MRI and bone scan * Clinical signs of chronic venous insufficiency (CEAP C3-C6) * History of lymph node dissection/ radiotherapy at the level of the pelvis or groin
References
Publications (0)
Data not yet available