Lymphoedema and nocturia/ nocturnal polyuria after pelvic lymph node dissection (LND) for urogenital cancer

Lymphoedema is caused by malfunction of the lymphatic system which can be accompanied by an increased load on this system. Some patients develop lymphoedema after treatment for cancer. In this case, we can speak of secundary lymphoedema or acquired lymphoedema. In 2018, 11 645 patients in Belgium were diagnosed with urogenital 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 our knowlegde, 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 exists regarding which (combination of) clinical measurement methods are most sensitive to detect early LLL after transpertioneal pelvic lymph node dissection. Tresholds to identify subclinical lymphoedema in one or both legs are lacking. Additionaly, the added value of manual lymphdrainage (MLD) to standard of care consisting of skincare, exercises and compression stocking(s) in patient with early (mild) lower limb lymphoedema has never been investigated. A pilot study on the feasibility of a clinical trial about the benefit of MLD in patients with early lymphoedema in the lower limbs is necessary. Besides lymphoedema in the lower limbs, treatment for cancer also often results in urinary problems. Urinary stress incontinence has been described most often in literature. However, in clinical practice, it is clear that prostatectomy is often associated with other urinary complications as nocturia and nocturnal polyuria. To our knowledge, there are no trials investigating the prognostic variables for the develompent of nocturia/ nocturnal polyuria after transperitoneal pelvic lymph node dissection for urogenital cancer.

Therefore, we will investigate 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 in a clinical trial. Additionally, 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) untill 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 he/she 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. After that, there will be 1 year of follow-up. When a particpant of the prospective observational trial develops mild LLL or lymphoedema at midline, the participant will be asked to participate in the randomized controlled pilot study. After signing the informed consent, the participant will be allocated to a group receiving manual lymph drainage and standard of care (experimental group) or only standard of care (control group). The duration of the randomize controlled pilot study is 2,5 years. 13 months to include patients with early (mild) lymphoedema in the lower limbs or at midline. Afterwards, there will be 1 year of follow-up.

Evaluation: Participants in the prospective observational trial will be evaluated 4 times: baseline (pre-surgery), 6 weeks, 6 and 12 months post-surgery. The evaluations of the randomized controlled pilot study are also performed 4 times: baseline, 3, 6 and 12 months post-diagnosis. 

Treatment: All participants in the prospective observational trial receive standard of care. This consists of information, skincare and exercises. The information about lymphoedema and lymphoedema prevention is given by the physical therapist of the department of urology during the hospital stay. Skincare consists of daily use of moisturizer on legs and feet, in addition to prevention and care of wounds. The exercises are supervised by the home physical therapist. The frequency of the sessions at the physical therapist are gradually decreased. The standard of care in the randomized controlled pilot study is the same except for compression stocking(s) or bermuda. Only participants allocated to the experimental group receive manual lymphdrainage. The frequency of the sessions of manual lymphdrainage are also gradually decreased.