7 research outputs found
Efficacy and safety of a hexanic extract of Serenoa repens (Permixon (R)) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH): systematic review and meta-analysis of randomised controlled trials and observational studies
Objectives To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens (HESr, Permixon (R); Pierre Fabre Medicament, Castres, France), at a dose of 320 mg daily, as monotherapy for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Materials and methods We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) and prospective observational studies in patients with LUTS/BPH identified through searches in Medline, Web of Knowledge (Institute for Scientific Information), Scopus, the Cochrane Library, and bibliographic references up to March 2017. Articles studying S. repens extracts other than Permixon were excluded. Data were collected on International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (ADRs). Data obtained from RCTs and observational studies were analysed jointly and separately using a random effects model. A sub-group analysis was performed of studies that included patients on longer-term treatment (= 1 year). Results Data from 27 studies (15 RCTs and 12 observational studies) were included for meta-analysis (total N = 5 800). Compared with placebo, the HESr was associated with 0.64 (95% confidence interval [CI] -0.98 to -0.31) fewer voids/ night (P < 0.001) and an additional mean increase in Q(max) of 2.75 mL/s (95% CI 0.57 to 4.93; P = 0.01). When compared with a-blockers, the HESr showed similar improvements on IPSS (weighted mean difference [WMD] 0.57, 95% CI -0.27 to 1.42; P = 0.18) and a comparable increase in Q(max) to tamsulosin (WMD -0.02, 95% CI -0.71 to 0.66; P = 0.95). Efficacy assessed using the IPSS was similar after 6 months of treatment between the HESr and 5a-reductase inhibitors (5ARIs). Analysis of all available published data for the HESr showed a mean improvement in IPSS from baseline of -5.73 points (95% CI -6.91 to -4.54; P < 0.001). HESr did not negatively affect sexual function and no clinically relevant effect was observed on prostate-specific antigen. Prostate volume decreased slightly. Similar efficacy results were seen in patients treated for = 1 year (n = 447). The HESr had a favourable safety profile, with gastrointestinal disorders being the most frequent ADR (mean incidence of 3.8%). Conclusion The present meta-analysis, which includes all available RCTs and observational studies, shows that the HESr (Permixon) reduced nocturia and improved Q(max) compared with placebo and had a similar efficacy to tamsulosin and short-term 5ARI in relieving LUTS. HESr (Permixon) appears to be an efficacious and well-tolerated therapeutic option for the longterm medical treatment of LUTS/BPH
Real-world therapeutic management and evolution of patients with benign prostatic hyperplasia in primary care and urology in Spain
Objectives: This study aimed to describe the real-world therapeutic management of
patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperpla-
sia (BPH) (LUTS/BPH) attending primary care and urology clinics in Spain.
Methods: This observational, retrospective, multicentre study included men
â„50 years of age diagnosed with LUTS/BPH (â€8 years prior to study visit) (N = 670).
Therapeutic management according to healthcare service (primary care vs. urology
clinics) or progression criteria, proportion of patients with treatment change, patient
profile according to therapy and evolution of LUTS severity were assessed.
Results: Overall differences were noticed in the management of patients between
healthcare service (P < .001) and with or without progression criteria (P < .05). Most
patients received pharmacological treatment at diagnosis (70.7%; 474/670), which in-
creased at study visit (81.6%; 547/670) with overall similar profiles between primary
care and urology clinics for each therapy. α1-Blockers were the most used pharmaco-
logical treatment across healthcare settings at diagnosis (61.8%; 293/474) and study
visit (51%; 279/547). Only 27.1% (57/210) of patients with progression criteria at diag-
nosis and 35.6% (99/278) at study visit received 5α-reductase inhibitor (5ARI) alone
or in combination with a α1-blocker. Overall, most patients did not change treatment
(60%; 402/670) with a trend of more patients worsening in symptoms when not re-
ceiving α1-blocker plus 5ARI combination therapy.
Conclusion: Most patients with LUTS/BPH received pharmacological treatment;
however, most men with progression criteria did not receive a 5ARI alone or in combi-
nation. These results support the need to reinforce both primary care and urologists
existing clinical guideline recommendations for the appropriate medical management
of patients with LUTS/BPH
Focal therapy of prostate cancer index lesion with irreversible electroporation. A prospective study with a median follow-up of 3 years
Purpose: Our aim was to assess oncologic, safety, and quality of lifeerelated
outcomes of focal therapy with irreversible electroporation in men with localized
prostate cancer.
Materials and Methods: This was a single-center, phase II study. Inclusion
criteria: prostate cancer International Society of Urological Pathology grade 1-2,
prostate specific antigen 15 ng/ml, cT2b. Patients were selected based on
multiparametric magnetic resonance imaging and transperineal systematic and
targeted magnetic resonance imagingeultrasound fusioneguided biopsy. Ablation of index lesions with safety margin was performed. Primary end point was
cancer control, defined as the absence of any biopsy-proven tumor. A control
transperineal biopsy was planned at 12 months and when suspected based on
prostate specific antigen and/or multiparametric magnetic resonance imaging
information. Quality of life was assessed using Expanded Prostate Cancer Index
Composite Urinary Continence domain, International Index of Erectile Function,
and International Prostate Symptom Score.
Results: From November 2014 to July 2021, 41 consecutive patients were included
with a median follow-up of 36 months. Thirty patients (73%) had International
Society of Urological Pathology grade 1 tumors, 10 (24%) grade 2, and 1 (2.4%)
grade 3. Recurrence was observed in 16 of 41 (39%) of the whole cohort, and 16 of 33 (48.4%) who underwent biopsy. In-field recurrence was detected in 5 (15%) and out-of-field in 11 (33.3%). Ten
of 41 (24.6%) including 3 of 5 (60%) with in-field recurrences had significant tumors (Gleason pattern 4-5; more
than 1 core or any >5 mm involved). Median recurrence-free survival was 32 months (95% CI 6.7-57.2). Twentysix patients (63.4%) were free from salvage treatment. All patients preserved urinary continence. Potency was
maintained in 91.8%.
Conclusions: Irreversible electroporation can achieve satisfactory 3-year in-field tumor control with excellent
quality of life results in selected patients
Characterization of the perioperative changes of exosomal immune-related cytokines induced by prostatectomy in early-stage prostate cancer patients
Background: Myeloid-derived suppressor cells (MDSCs) are relevant in prostate cancer microenvironment
collaborating in tumor development. The main tumor marker used in this disease, prostate-specific antigen
(PSA), does not provide information related to this tumor microenvironment. Cancer cells secrete exosomes
carrying bioactive molecules contributing to MDSCs recruitment and induction. The aim of this study was to
characterize the perioperative changes of exosomal cytokines relevant in MDSCs recruitment induced by pros-
tatectomy in prostate cancer patients.
Methods: Blood was drawn from 26 early-stage prostate cancer patients before and after radical prostatectomy
and from 16 healthy volunteers. Serum exosomes were separated by precipitation. Cytokines related with MDSC
cell recruitment and activation CCL2, CXCL2, CXCL5, CXCL8, CXCL12, MIF, S100A9 and TGF-Ă were measured
in serum and serum-derived exosomes using immunometric assays.
Results: All cytokines were detected both in serum and exosomes, except for CXCL12, which was detected only in serum. Exosomes were enriched specially in MIF, TGF-Ă and CXCL2. Presurgical MIF levels in exosomes correlated negatively with serum PSA. Also, presurgical TGF-Ă decreased both in serum and exosomes as Gleason score rises. PatientsÌ presurgical exosomes had increased CCL2, CXCL5 and TGF-Ă levels than exosomes from healthy controls. These differences were not observed when cytokines were analyzed in serum, except for TGF-Ă.Cytokine levels of CCL2, CXCL5 decreased in patientsâ postsurgical exosomes, while TGF-Ă further increased. On the contrary, S100A9 levels were lower in patientsÌ presurgical exosomes but increased after radical prostatectomy.
Conclusions: Blood exosomal content in cytokines constitute an attractive source to evaluate MDSCs immuno-
modulators providing additional information related to tumor microenvironment in prostate cance
Characterization of the perioperative changes of exosomal immune-related cytokines induced by prostatectomy in early-stage prostate cancer patients
Background: Myeloid-derived suppressor cells (MDSCs) are relevant in prostate cancer microenvironment
collaborating in tumor development. The main tumor marker used in this disease, prostate-specific antigen
(PSA), does not provide information related to this tumor microenvironment. Cancer cells secrete exosomes
carrying bioactive molecules contributing to MDSCs recruitment and induction. The aim of this study was to
characterize the perioperative changes of exosomal cytokines relevant in MDSCs recruitment induced by pros-
tatectomy in prostate cancer patients.
Methods: Blood was drawn from 26 early-stage prostate cancer patients before and after radical prostatectomy
and from 16 healthy volunteers. Serum exosomes were separated by precipitation. Cytokines related with MDSC
cell recruitment and activation CCL2, CXCL2, CXCL5, CXCL8, CXCL12, MIF, S100A9 and TGF-Ă were measured
in serum and serum-derived exosomes using immunometric assays.
Results: All cytokines were detected both in serum and exosomes, except for CXCL12, which was detected only in serum. Exosomes were enriched specially in MIF, TGF-Ă and CXCL2. Presurgical MIF levels in exosomes correlated negatively with serum PSA. Also, presurgical TGF-Ă decreased both in serum and exosomes as Gleason score rises. PatientsÌ presurgical exosomes had increased CCL2, CXCL5 and TGF-Ă levels than exosomes from healthy controls. These differences were not observed when cytokines were analyzed in serum, except for TGF-Ă.Cytokine levels of CCL2, CXCL5 decreased in patientsâ postsurgical exosomes, while TGF-Ă further increased. On the contrary, S100A9 levels were lower in patientsÌ presurgical exosomes but increased after radical prostatectomy.
Conclusions: Blood exosomal content in cytokines constitute an attractive source to evaluate MDSCs immuno-
modulators providing additional information related to tumor microenvironment in prostate cance
What is the impact of postâradical prostatectomy urinary incontinence on everyday quality of life? Linking Pad usage and International Consultation on Incontinence Questionnaire ShortâForm (ICIQâSF) for a COMBined definition (PICOMB definition)
Aims: To identify the definition for urinary continence (UC) after radical
prostatectomy (RP) which reflects best patients' perception of quality of
life (QoL).
Methods: Continence was prospectively assessed in 634 patients, 12 months
after RP using the International Consultation on Incontinence Questionnaire
ShortâForm (ICIQâSF) and the number of pads employed in a 24âhour period
(pad usage). We used the oneâway ANOVA technique with posthoc pairwise
comparisons according to Scheffé's method (homogeneous subsets) for assessing the degree of QoL deficit related to urinary incontinence (UI).
Results: The continence prevalence is 64.4%, 74.1%, 88.3%, and 35.8% using â0
pads,â â1 safety pad,â â1 pad,â and âICIQ score 0â definitions, respectively. Pad
usage is moderately strongly associated with ICIQ 1, 2, and 3 (Ï = 0.744, 0.677,
and 0.711, respectively; p < 0.001). Concordance between classical UC definitions is acceptable between â0 padsâICIQ score 0â (K = 0.466), but poor for
â1 safety padâ and â1 padâ (K = 0.326 and 0.137, respectively). Patients with â0
pad usageâ have better QoL related to urine leakage than patients with â1
safety padâ or â1 padâ (1.41 vs. 2.44 and 3.11, respectively; p < 0.05). There
were no significant differences found regarding QoL between patients with
ICIQ score 0 and ICIQ score 2 (1.01 vs. 1.63; p = 0.63).Conclusions: Pad usage and the ICIQâSF's answers provide useful information. We propose a combined definition (0 pads and ICIQ score â€2) as it is the
definition with the least impact on daily QoL