Urogenital CancerUroLymphNCT05300308
Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer
An observational study of Urogenital Cancer and Lower Limb Lymphedema, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urogenital Cancer, Lower Limb Lymphedema, Nocturia
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Jan 2022to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients planned for transperitoneal pelvic lymph node dissection for treatment of urogenital cancer (including prostate or bladder cancer)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Charlotte Van Calster, MSc. contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven, campus Gasthuisberg
Leuven, Flanders, 3000
About this study
Official title: Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND): Prospective Observational Study
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).
Read the detailed description
Lymphoedema is caused by malfunction of the lymphatic system whether or not in combination with extra load on this system. Some patients develop lymphoedema after treatment for cancer: secondary lymphoedema or acquired lymphoedema. In 2018, 11 645 patients in Belgium were diagnosed with urogenital cancer cancer, including prostate and bladder cancer. A possible treatment consists of prostatectomy or cystectomy in combination with transperitoneal pelvic lymph node dissection. Patients who undergo treatment for cancer may develop lower limb lymphoedema or lymphoedema at midline. To the researchers knowledge, investigation of incidence of lower limb lymphoedema (LLL) is limited. Also, the prognostic variables for the development of LLL are unknown. Furthermore, no scientific evidence consists regarding which (combination of) clinical measurement methods are most sensitive to detect early LLL after transperitoneal pelvic lymph node dissection. Thresholds to identify subclinical lymphoedema in one or both legs are lacking. Besides lymphoedema in the lower limbs, treatment for cancer also often results in urinary problems. Especially urinary stress incontinence has been described in literature. However, in clinical practice, it is clear that prostatectomy is often associated with other urinary complications, as nocturia and nocturnal polyuria. To the researchers knowledge, there are no trials investigating the prognostic variables for the development of nocturia/ nocturnal polyuria after transperitoneal pelvic lymph node dissection for urogenital cancer.
Therefore, the researchers will execute a trial investigating the epidemiology (i. e incidence, prevalence and prognostic variables), detection methods and the feasibility of a trial about the early treatment of LLL after transperitoneal pelvic lymph node dissection for urogenital cancer. The epidemiology of LLL, nocturia and nocturnal polyuria will be investigated.
Participants: 150 patients undergoing a transperitoneal pelvic lymph node dissection for urogenital cancer will be included. These participants will be followed-up from baseline (pre-surgery) until 1 year post-surgery. All participants are evaluated at the University Hospitals Leuven, campus Gasthuisberg.
Procedure: The potential participant will be screened first to see if the patients meets the inclusion criteria. After signing the informed consent form, the participant will be followed in the prospective observational trial. The duration of the prospective observational trial is 2 years. Participants can be included until 1 year after the start of the trial.
Evaluation: There will be clinical evaluation of lymphoedema as well as treatment for lymphoedema. Participants in the prospective observational trial will be evaluated 4 times: baseline (pre-surgery), 6 weeks, 6 and 12 months post-surgery.
Treatment: All participants in the prospective observational trial receive standard of care. This consists out of information, skincare and exercises. The information about lymphoedema and its prevention is given by the physical therapist of the department of urology during the hospital stay. Skincare consists of daily moisturizer of legs and feet and prevention and care of wounds. The exercises are supervised by the home physical therapist. The frequency of the session at the physical therapist are gradually decreased.
- Conditions
- Urogenital Cancer, Lower Limb Lymphedema, Nocturia, Nocturnal Polyuria
- Being tested
- usual care
- Medical subject headings
- Urogenital Neoplasms, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 12 months post-surgery
Secondary outcomes (24)
Point prevalence rate of lower limb lymphoedema (i.e. number of patients with lower limb lymphoedema)
Calculation of the proportion of patients with leg lymphoedema at a certain time point (defined as 5.0% or more increase of the leg volume) and calculation of the proportion of patients with midline lymphoedema at a certain time point (defined as 20% or more increase of the baseline water content at the prepubic region): 6 weeks, 6 and 12 months post-surgery
Measured: up to 12 months post-surgery
Reliability of detection lower limb lymphoedema developing after the treatment of urogenital cancer
To investigate reliability, all participants with lower limb lymphoedema at 12 months post-surgery will be evaluated three times with each evaluation method: intra and interrater reliability will be determined
Measured: 12 months post-surgery
Time efficiency of lymphoedema measurements
To determine feasibility of each method, time efficiency will be examined for each method: setup time (time needed to prepare the measurement), execution time ( time needed for a bilaterally execution of the measurement) and total time (required for the setup and the execution of the measurement) (min, sec)
Measured: 12 months post-surgery
Presence of limitations of lymphoedema measurements
limitations regarding clinical feasibility will be listed and scored (yes/no) for each method.
Measured: 12 months post-surgery
Validity of lymphoedema measurements
As "gold standard" to compare the different measurement methods with, every patient will be evaluated individually once by the project's international expert panel, during a monthly (virtual) meeting (2 up to 3h). They will decide whether patients should be labelled as showing 'presence of early signs of lower limb lymphoedema (1)' or 'no signs (0)'. Decision making will occur with an initial assessment of the experts, i.e. in advance of the monthly meeting. Then the project manager will lead the meeting on the basis of the assessments and subsequently conduct a new 'vote'. In case >2/3 of the experts (= clear majority) decides a patient should receive a diagnosis of lymphoedema, then this patient receives the diagnosis.
Measured: 12 months post-surgery
diagnostic accuracy of the screening methods for lower limb lymphoedema
outcomes resulting from the measurement method will be compared against the yes/no score regarding clinical presence of LLL from our international expert group
Measured: 12 months post-surgery
Point prevalence rate of nocturia and nocturnal polyuria
Calculation of the proportion of patients with nocturia/ nocturnal polyuria at a certain time point: baseline, at 6 weeks, 6 and 12 months post-surgery
Measured: up to 12 months post-surgery
Prognostic value of 'baseline age' for the development of nocturia and nocturnal polyuria
Age (years) will be self-reported through interview
Measured: 12 months
Prognostic value of 'late-night fluid intake' for the development of nocturia and nocturnal polyuria
late-night fluid intake will be assessed through the micturition chart that (during 24 hours, in the week prior to the assessment visit) has to be filled in by the patient before surgery and at 6 weeks, 6 months and 12 months after surgery. The patient has to write down the time, frequency and quantity of urinating during the day and night. The time of drinking a consumption, the amount of a consumption and which consumption also has to be recorded.
Measured: 12 months
Prognostic value of 'late-night caffeine/alcohol use (3 hours before going to bed)' for the development of nocturia and nocturnal polyuria
late-night caffeine/alcohol use (3 hours before going to bed) will be assessed through the micturition chart that (during 24 hours, in the week prior to the assessment visit) has to be filled in by the patient before surgery and at 6 weeks, 6 months and 12 months after surgery. The patient has to write down the time, frequency and quantity of urinating during the day and night. The time of drinking a consumption, the amount of a consumption and which consumption also has to be recorded.
Measured: 12 months
Prognostic value of 'comorbidities' for the development of nocturia and nocturnal polyuria
Comorbidities will be reported through a self-developed co-morbidity questionnaire, based on IDEWE questionnaire.
Measured: 12 months
Prognostic value of 'baseline fat mass' for the development of nocturia and nocturnal polyuria
Baseline fat mass will be measured using Bio-impedance Spectroscopy
Measured: 12 months
Prognostic value of 'baseline physical activity' for the development of nocturia and nocturnal polyuria
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.
Measured: 12 months
Prognostic value of 'baseline educational level' for the development of nocturia and nocturnal polyuria
Educational level will be self-reported through interview.
Measured: 12 months
Prognostic value of 'type of cancer' for the development of nocturia and nocturnal polyuria
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.
Measured: 12 months
Prognostic value of 'tumor stage' for the development of nocturia and nocturnal polyuria
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.
Measured: 12 months
Prognostic value of 'lymph node stage' for the development of nocturia and nocturnal polyuria
information regarding the lymph node stage is collected by exploring the patient's medical file.
Measured: 12 months
Prognostic value of 'number of positive lymph nodes' for the development of nocturia and nocturnal polyuria
Number of positive lymph nodes is collected through the patient's medical file.
Measured: 12 months
Prognostic value of 'postoperative complications' for the development of nocturia and nocturnal polyuria
Surgical complications will be assessed according to the Clavien-Dindo Classification of Surgical Complications. Complications will be determined as 30-day, 90-day or late (>90 days) complications.
Measured: 12 months
Prognostic value of 'type of lymph node dissection' for the development of nocturia and nocturnal polyuria
Information about the type of lymph node dissection is collected by exploring the patient's medical file.
Type of lymph node dissection: Limited- Standard- Extended- Super extended
Measured: 12 months
Prognostic value of 'number of lymph nodes removed' for the development of nocturia and nocturnal polyuria
number of lymph nodes removed: by exploring the patient's medical file.
Measured: 12 months
Prognostic value of 'radiotherapy' for the development of nocturia and nocturnal polyuria
Cancer treatment characteristics , including radiotherapy are collected; by exploring the patient's medical file.
Measured: 12 months
Prognostic value of 'presence of postoperative drain' for the development of nocturia and nocturnal polyuria
Cancer treatment characteristics are collected, including the presence of postoperative drain, are collected by exploring the patient's medical file.
Measured: 12 months
Prognostic value of 'presence of lymphoedema' for the development of nocturia and nocturnal polyuria
The presence of leg lymphoedema (defined as 5.0% or more increase of the leg volume) and midline lymphoedema (defined as 20% or more increase of the baseline water content at the prepubic region)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start21 Jan 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urogenital CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nele Devoogdt, Prof. Dr., Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300308
- Sponsor's protocol ID
- s66072
- Acronym
- UroLymph
- Status last verified
- Jul 2025
- First submitted
- 17 Jan 2022
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND): Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05300308
- Acronym / sponsor ID
- UroLymph / s66072
- Conditions
- Urogenital Cancer, Lower Limb Lymphedema, Nocturia, Nocturnal Polyuria
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Lymphoedema is caused by malfunction of the lymphatic system whether or not in combination with extra load on this system. Some patients develop lymphoedema after treatment for cancer: secondary lymphoedema or acquired lymphoedema. In 2018, 11 645 patients in Belgium were diagnosed with urogenital cancer cancer, including prostate and bladder cancer. A possible treatment consists of prostatectomy or cystectomy in combination with transperitoneal pelvic lymph node dissection. Patients who undergo treatment for cancer may develop lower limb lymphoedema or lymphoedema at midline. To the researchers knowledge, investigation of incidence of lower limb lymphoedema (LLL) is limited. Also, the prognostic variables for the development of LLL are unknown. Furthermore, no scientific evidence consists regarding which (combination of) clinical measurement methods are most sensitive to detect early LLL after transperitoneal pelvic lymph node dissection. Thresholds to identify subclinical lymphoedema in one or both legs are lacking. Besides lymphoedema in the lower limbs, treatment for cancer also often results in urinary problems. Especially urinary stress incontinence has been described in literature. However, in clinical practice, it is clear that prostatectomy is often associated with other urinary complications, as nocturia and nocturnal polyuria. To the researchers knowledge, there are no trials investigating the prognostic variables for the development of nocturia/ nocturnal polyuria after transperitoneal pelvic lymph node dissection for urogenital cancer.
Therefore, the researchers will execute a trial investigating the epidemiology (i. e incidence, prevalence and prognostic variables), detection methods and the feasibility of a trial about the early treatment of LLL after transperitoneal pelvic lymph node dissection for urogenital cancer. The epidemiology of LLL, nocturia and nocturnal polyuria will be investigated.
Participants: 150 patients undergoing a transperitoneal pelvic lymph node dissection for urogenital cancer will be included. These participants will be followed-up from baseline (pre-surgery) until 1 year post-surgery. All participants are evaluated at the University Hospitals Leuven, campus Gasthuisberg.
Procedure: The potential participant will be screened first to see if the patients meets the inclusion criteria. After signing the informed consent form, the participant will be followed in the prospective observational trial. The duration of the prospective observational trial is 2 years. Participants can be included until 1 year after the start of the trial.
Evaluation: There will be clinical evaluation of lymphoedema as well as treatment for lymphoedema. Participants in the prospective observational trial will be evaluated 4 times: baseline (pre-surgery), 6 weeks, 6 and 12 months post-surgery.
Treatment: All participants in the prospective observational trial receive standard of care. This consists out of information, skincare and exercises. The information about lymphoedema and its prevention is given by the physical therapist of the department of urology during the hospital stay. Skincare consists of daily moisturizer of legs and feet and prevention and care of wounds. The exercises are supervised by the home physical therapist. The frequency of the session at the physical therapist are gradually decreased.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transperitoneal pelvic lymph node dissection for treatment of urogenital cancer | – | Other: usual carepatients planned for transperitoneal pelvic lymph node dissection for treatment of urogenital cancer (including prostate or bladder cancer) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients planned for transperitoneal pelvic lymph node dissection for treatment of urogenital cancer (including prostate or bladder cancer)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual careThe 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. | Other | transperitoneal pelvic lymph node dissection for treatment of urogenital cancer |
Primary outcome
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
Time frame: 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)
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
Time frame: 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)
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
Time frame: 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)
Prognostic value of 'baseline age' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 12 months post-surgery
Dependent variable = presence of leg lymphoedema/ presence of midline lymphoedema Independent variable= Age (years) will be self-reported through interview.
Prognostic value of ' Baseline fat mass' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 12 months post-surgery
Baseline fat mass will be measured using Bio-impedance Spectroscopy
Prognostic value of ' Baseline physical activity level' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 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.
Prognostic value of ' Baseline educational level' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 12 months post-surgery
Educational level will be self-reported through interview.
Prognostic value of ' baseline comorbidities' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 12 months post-surgery
Comorbidities will be reported through a self-developed co-morbidity questionnaire, based on IDEWE questionnaire.
Prognostic value of 'type of cancer' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 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.
Prognostic value of 'Tumor stage' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 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.
Prognostic value of 'Lymph node stage' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 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.
Prognostic value of 'number of positive lymph nodes' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 12 months post-surgery
Number of positive lymph nodes is collected through the patient's medical file.
Prognostic value of 'postoperative complications' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 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.
Prognostic value of 'type of lymph node dissection' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 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
Prognostic value of 'number of lymph nodes removed' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 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.
Prognostic value of 'Adjuvant Radiotherapy' for the development of lower limb lymphoedema at 12 months post-surgery.
Time frame: 12 months post-surgery
Cancer treatment characteristics , including adjuvant radiotherapy are collected; by exploring the patient's medical file.
24 secondary outcomes
Point prevalence rate of lower limb lymphoedema (i.e. number of patients with lower limb lymphoedema)
Time frame: up to 12 months post-surgery
Reliability of detection lower limb lymphoedema developing after the treatment of urogenital cancer
Time frame: 12 months post-surgery
Time efficiency of lymphoedema measurements
Time frame: 12 months post-surgery
Presence of limitations of lymphoedema measurements
Time frame: 12 months post-surgery
Validity of lymphoedema measurements
Time frame: 12 months post-surgery
diagnostic accuracy of the screening methods for lower limb lymphoedema
Time frame: 12 months post-surgery
Point prevalence rate of nocturia and nocturnal polyuria
Time frame: up to 12 months post-surgery
Prognostic value of 'baseline age' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'late-night fluid intake' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'late-night caffeine/alcohol use (3 hours before going to bed)' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'comorbidities' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'baseline fat mass' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'baseline physical activity' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'baseline educational level' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'type of cancer' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'tumor stage' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'lymph node stage' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'number of positive lymph nodes' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'postoperative complications' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'type of lymph node dissection' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'number of lymph nodes removed' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'radiotherapy' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'presence of postoperative drain' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Prognostic value of 'presence of lymphoedema' for the development of nocturia and nocturnal polyuria
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte Van Calster, MSc. contact
Nele Devoogdt, Prof. Dr. principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urogenital Cancer and Lower Limb Lymphedema, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nele Devoogdt, Prof. Dr. (+3216342515, nele.devoogdt@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 weeks post-surgery). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.