RecruitingNCT05300308

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

150 participants

Start Date

Jan 21, 2022

Study Type

OBSERVATIONAL

Conditions

Nocturia Urogenital Cancer Lower Limb Lymphedema

Summary

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria3

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

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Interventions

OTHERusual care

The information about lymphoedema and its prevention is given during the hospital stay by the physical therapist of the department of urology. Skincare consists of daily skin moisturizer of feet and legs and prevention and care of wounds. Active exercises are performed to gain endurance and muscle strength after surgery and to stimulate the blood and lymph circulation. The exercises are supervised by the home physical therapist. Frequency of the supervised exercises is gradually decreased. If a patient develops lymphoedema, he/she receives compression stockings.