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

NCT05300308 | Recruiting

• 1 other identifier: s66072
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Urogenital Cancer; Lower Limb Lymphedema; Nocturia; Nocturnal Polyuria

Outcome Measures

Primary Outcomes (16)

• 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

  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)

  6 weeks post-surgery

• 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

  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)

  6 months post-surgery

• Cumulative incidence rate of lower limb lymphoedema after urogenital cancer (i.e. number of patients with newly diagnosed lower limb lymphoedema) 12 months post-surgery

  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)

  12 months post-surgery

• Prognostic value of 'baseline age' for the development of lower limb lymphoedema at 12 months post-surgery.

  Dependent variable = presence of leg lymphoedema/ presence of midline lymphoedema Independent variable= Age (years) will be self-reported through interview.

  12 months post-surgery

• Prognostic value of ' Baseline fat mass' for the development of lower limb lymphoedema at 12 months post-surgery.

  Baseline fat mass will be measured using Bio-impedance Spectroscopy

  12 months post-surgery

• Prognostic value of ' Baseline physical activity level' for the development of lower limb lymphoedema at 12 months post-surgery.

  Baseline physical activity level will be assessed with the International Physical Activity Questionnaire (IPAQ). The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.

  12 months post-surgery

• Prognostic value of ' Baseline educational level' for the development of lower limb lymphoedema at 12 months post-surgery.

  Educational level will be self-reported through interview.

  12 months post-surgery

• Prognostic value of ' baseline comorbidities' for the development of lower limb lymphoedema at 12 months post-surgery.

  Comorbidities will be reported through a self-developed co-morbidity questionnaire, based on IDEWE questionnaire.

  12 months post-surgery

• Prognostic value of 'type of cancer' for the development of lower limb lymphoedema at 12 months post-surgery.

  Information regarding the type of urogenital cancer (prostate versus bladder) and the stage of the urogenital cancer is collected (i.e. histological subtype, PSA (if PCa), pTN stage, ISUP grade group (if PA); by exploring the patient's medical file.

  12 months post-surgery

• Prognostic value of 'Tumor stage' for the development of lower limb lymphoedema at 12 months post-surgery.

  Information regarding the type of urogenital cancer (prostate versus bladder) and the stage of the urogenital cancer is collected (i.e. histological subtype, PSA (if PCa), pTN stage, ISUP grade group (if PA); by exploring the patient's medical file.

  12 months post-surgery

• Prognostic value of 'Lymph node stage' for the development of lower limb lymphoedema at 12 months post-surgery.

  Information regarding the type of urogenital cancer (prostate versus bladder) and the stage of the urogenital cancer is collected (i.e. histological subtype, PSA (if PCa), pTN stage, ISUP grade group (if PA); by exploring the patient's medical file.

  12 months post-surgery

• Prognostic value of 'number of positive lymph nodes' for the development of lower limb lymphoedema at 12 months post-surgery.

  Number of positive lymph nodes is collected through the patient's medical file.

  12 months post-surgery

• Prognostic value of 'postoperative complications' for the development of lower limb lymphoedema at 12 months post-surgery.

  Information regarding the complications related to the surgery as well as adjuvant therapies is collected. Surgical complications will be assessed according to the Clavien-Dindo Classification of Surgical Complications.

  12 months post-surgery

• Prognostic value of 'type of lymph node dissection' for the development of lower limb lymphoedema at 12 months post-surgery.

  Cancer treatment characteristics are collected (i.e. type of surgery, type of lymph node dissection, number of lymph nodes removed, presence of postoperative drain, number of positive lymph nodes, adjuvant therapies; by exploring the patient's medical file. Type of lymph node dissection: Limited- Standard- Extended- Super extended

  12 months post-surgery

• Prognostic value of 'number of lymph nodes removed' for the development of lower limb lymphoedema at 12 months post-surgery.

  Cancer treatment characteristics are collected (i.e. type of surgery, type of lymph node dissection, number of lymph nodes removed, presence of postoperative drain, number of positive lymph nodes, adjuvant therapies; by exploring the patient's medical file.

  12 months post-surgery

• Prognostic value of 'Adjuvant Radiotherapy' for the development of lower limb lymphoedema at 12 months post-surgery.

  Cancer treatment characteristics , including adjuvant radiotherapy are collected; by exploring the patient's medical file.

  12 months post-surgery

Secondary Outcomes (24)

• Point prevalence rate of lower limb lymphoedema (i.e. number of patients with lower limb lymphoedema)

  up to 12 months post-surgery

• Reliability of detection lower limb lymphoedema developing after the treatment of urogenital cancer

  12 months post-surgery

• Time efficiency of lymphoedema measurements

  12 months post-surgery

• Presence of limitations of lymphoedema measurements

  12 months post-surgery

• Validity of lymphoedema measurements

  12 months post-surgery

Study Arms (1)

transperitoneal pelvic lymph node dissection for treatment of urogenital cancer

patients planned for transperitoneal pelvic lymph node dissection for treatment of urogenital cancer (including prostate or bladder cancer)

Other: usual care

Interventions

usual care OTHER

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.

transperitoneal pelvic lymph node dissection for treatment of urogenital cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients planned for transperitoneal pelvic lymph node dissection for treatment of urogenital cancer (including prostate or bladder cancer)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven, campus Gasthuisberg

Leuven, Flanders, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Urogenital Neoplasms; Nocturia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nele Devoogdt, Prof. Dr.

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nele Devoogdt, Prof. Dr.

CONTACT

+3216342515; nele.devoogdt@uzleuven.be

Charlotte Van Calster, MSc.

CONTACT

charlotte.vancalster@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: March 29, 2022
• Study Start: January 21, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

BE (1)