LUTS.COM Study – Evaluation and management of LUTS associated to BPH in the Context of Common Comorbidities
Patients with Lower Urinary Tract Symptoms (LUTS) due to Benign Prostate Hypertrophy (BPH) frequently have comorbidities related to the cardiovascular system such as arterial hypertension, diabetes, hyperlipidemia and metabolic syndrome (1 – 8). In particular, BPH, causing nocturia- induced sleep disturbance, may have a possible impact on blood pressure variability during night- time (1). Patients with BPH also frequently complain of depression (9, 10), osteoarthritis (11) chronic renal disease (12), erectile dysfunction (2, 4, 7), and diabetes (13) and, finally they are frequently exposed to potentially hypotensive agents such as PDE5-inhibitors (14,15,16).
The pharmacological management of BPH with associated comorbidities is particularly complex with risk of multiple interactions among the different types of treatments (7, 14, 17, 18) and an high likelihood of early discontinuation of therapy; notwithstanding this, the impact of co-medications and comorbidities on therapeutic choice is still to be ascertained (19). In general, the evaluation of comorbidities is considered highly relevant for the management of patients with BPH (20).
The LUTS.COM (Evaluation and management of LUTS associated to BPH in the context of Common COMorbidities) observational study was designed to assess the prevalence of significant comorbidities in male patients attending a visit for LUTS associated with BPH at an outpatient clinical ward.
Moreover, the study aims (i) to describe the medications administered for comorbidities, (ii) to assess the patients’ quality of life patients by means of the nocturia-specific Quality-of-Life (N- QOL) questionnaire administered during the visit, and (iii) to describe the patients’ adherence to the anti-BPH medications as assessed by the Morisky 4-Item Self-Report Measure of Medication Adherence Scale (MMAS-4) (21, 22, 23), administered during the visit, in patients under pharmacologic treatment
Materials and Methods
The LUTS.COM study is an Italian, observational, multicenter, cross-sectional study endorsed by AURO.it (Associazione Urologi Ospedalieri).
At the enrolment visit, retrospective data such as diagnostic tests, and urological parameters (i.e. plasma levels of PSA, IPSS scores, Qmax, results of digital rectal examination or trans-rectal or suprapubic echographies) were collected up to 3 months earlier; moreover, data regarding comorbidities and pharmacological treatments for significant comorbidities and for LUTS were recorded. We focused on significant medical conditions such as arterial hypertension, known ischemic heart disease, known cerebrovascular disease, known peripheral arterial disease of lower limbs, diabetes mellitus, osteoporosis, major depressive disorder, chronic renal disorder, osteoarthritis, metabolic syndrome, and erectile dysfunction (as reported by patients). The patients’
To be considered as evaluable for the LUTS.COM study, patients had to be aged >= 50 years and present LUTS associated to BPH at enrolment as per clinical judgment. Patients who met the
following exclusion criteria were not considered as evaluable for the analyses: patients who received any investigational compound within 90 days prior to inclusion; patients who were immediate family members, study site employee, or in dependent relationship with a study site employee involved in the study; patients with known contra-indication to the medication prescribed for LUTS; patients who present or refer a known overactive bladder syndrome or prostate cancer.
quality of life was assessed by means of the N-QoL questionnaire. The N-QoL questionnaire (24) specifically measures the effect of nocturia on quality of sleep and consists of 12 items scored from 0 to 4 and one item regarding quality of life. Two sub-scales (sleep/energy and bother/concern) scores and an overall score can be calculated. Higher scores mean better quality of life. Finally, patients’ adherence to the anti-BPH therapies were evaluated by the MMAS-4. The MMAS-4 is a self-reported, medication-taking behavior scale and consists of four questions about the way patients might experience drug errors or omissions. The MMAS-4 score is a non- adherence score ranging from 0 to 4 (21, 22, 23); a higher score means higher adherence to therapy.
Patients were consecutively enrolled from December 2014 to December 2015. The LUTS.COM study involved 29 Urology Italian Centers that enrolled 807 male patients. Final statistical analyses are currently ongoing.
Data are not available yet. Statistical analyses will be performed in order to respond to the study objectives.
The management of patients with LUTS due to BPH is strongly influenced by the frequent presence of multiple comorbidities, and so, it is fundamental to have a clear idea of what is the distribution of comorbidities among these patients, in the Italian context. This study will allow to describe comorbidities in Italian patients affected by LUTS suggestive of BPH.
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