Digital rectal examination impact on PSA derivatives and prostate biopsy triggers: a contemporary study.

OBJECTIVE: To evaluate the impact of the digital rectal exam (DRE) on PSA measurements and clinical decision-making. METHODS: Healthy male volunteers between 50 and 70 years old were recruited during a 30-day public screening program. PSA levels were measured using two different methods (standard enhanced chemiluminescence immunoassay-ECLIA, and novel immunochromatography assay-ICA/rapid PSA) in the same blood sample. Two blood samples were drawn; first before DRE and the second 30-40 min after DRE. The effect of DRE on PSA levels and its impact on clinical decision-making for individual patients were evaluated based on different biopsy trigger cutoffs. RESULTS: ECLIA-PSA was measured in 74 participants both pre- and 37 ± 5 min post-DRE, mean age 57.2 ± 8.3 years, and mean prostate volume 33.6 (20-80) cm3. Both total and free ECLIA-PSA increased significantly after DRE (mean increase of 0.47 and 0.26 ng/ml, respectively, both p < 0.001). Different internationally accepted biopsy triggers were reached after DRE only: 5 total PSA > 3 ng/ml, 13 increase > 0.75 ng/ml, 3 PSA density > 0.15, and 1 free/total PSA < 0.18. On two occasions, patients were pushed away from biopsy trigger after DRE due to free/total PSA > 0.18. ICA-PSA was detectable (> 2.0 ng/ml) in 5 of 45 measured samples (11%) before DRE and 13/45 (29%) after DRE, p = 0.0316. Four among five detectable ICA-PSA tests increased after DRE. CONCLUSION: Performing DRE immediately before PSA measurement might change the clinical decision-making on a significant number of occasions (roughly 1 in 3); even though the mean increase (0.47 ng/ml) looks deceivingly small. Further studies are required that include gold standard tests (biopsy, or imaging).

The Biopsychosocial Burden of Prostate Biopsy at the Time of Its Indication, Procedure, and Pathological Report.

PURPOSE: To explore the burden of prostate biopsy at the time of its indication, procedure, and pathological report in the prostate cancer-screening scenario that is neglected and underestimated in the literature. METHODS: Prostate biopsy was offered to 47 consecutive patients with prostate-specific antigen (PSA) over 4 ng/dl or suspicious digital rectal examination (DRE) of whom 16 had undergone a biopsy. Comprehensive validated questionnaires at Time 0 (prebiopsy), Time 1 (before diagnosis, 20 days after biopsy), and Time 2 (after diagnosis, 40 days after biopsy) accessed patients' erectile (IIEF-5) and voiding (IPSS) functions, Beck scales measured anxiety (BAI), hopelessness (BHS), and depression (BDI), added to the emotional thermometers including five visual analog scales for distress, anxiety, depression, anger, and need for help. The Mann-Whitney or Friedman tests were obtained among times and studied variables. RESULTS: Prostate biopsy did not significantly impact patients' erectile and voiding functions while a higher Beck anxiety index (BAI) was observed at Time 0 (6.89 ± 6.33) compared to Time 1 (4.83 ± 2.87), p=0.0214, and to Time 2 (4.22 ± 4.98), p=0.0178. At Time 0, patients that experienced a previous biopsy presented higher distress (3.1 ± 3.0 vs. 1.6 ± 2.3), p=0.043, and emotional suffering thermometer scores (2.3 ± 3.3 vs. 0.9 ± 2.4) compared to those undergoing the first biopsy, p=0.036. At Time 2, patients with positive biopsies compared with those with negative ones showed no significant difference in outcome scores. The sample power was >90%. CONCLUSIONS: To be considered in patients' counseling and care, the current study supports the hypothesis that the peak burden of prostate biopsy occurs at the time of its indication and might be higher for those experiencing rebiopsy, significantly impacting patients' psychosocial domains. TRIAL APPROVAL: This trial is registered under number NCT03783741.

Does underestimated penile size impact erectile function in healthy men?

The aim of this study is to assess the impact of objective (stretched) and subjective penile size in the erectile function in a urological check-up program on a cross-sectional study including 689 men aged 35-70 years. IIEF-5 questionnaire, physical examination (penile length, prostate volume, blood pressure, body mass index-BMI), metabolic syndrome (MS), comorbidities, habits (sexual intercourse frequency, physical activity, alcohol, and tobacco use), level of education, serum glucose, total testosterone, estradiol, PSA, lipid profile, and self-perceptions (ejaculation time and subjective penile size) were examined in multivariate models using logistic and linear regressions. Penile objective mean length was 13.08 cm ± 2.32 and 67 (9.72%) patients referred small penis self-perception. Seventy-six (11.03%) participants had severe erectile dysfunction (ED), 75 (10.88%) had mild to moderate and moderate ED, 112 (16.25%) had mild ED and 426 (61.83%) had no ED. Risk factors for ED that held statistical significance were self-perceived small penis (OR = 2.23, 95% CI 1.35-3.69, p = .0017), sexual intercourse frequency (per week) (OR = 0.45, 95% CI 0.38-0.52, p < .0001), satisfactory ejaculation time (no vs. yes, OR = 2.06, 95% CI 1.46-2.92, p < .0001), comorbidity (yes vs. no, OR = 2.01, 95% CI 1.46-2.76, p < .0001), age >65 years (OR = 2.93, 95% CI 1.53-5.61, p < .0001), tobacco use (yes vs. no, OR = 1.41, 95% CI 1.02-1.96, p < .0375), regular physical activity (no vs. yes, OR = 1.59, 95% CI 1.13-2.23, p < .0083), serum total testosterone < 200 ng/dl (OR = 3.48, 95% CI 1.69-7.16, p = 0.0009), serum glucose > 100 mg/dl (OR = 1.69, 95% CI 1.18-2.43, p = 0.0044) and systolic blood pressure > 130 mmHg (OR = 1.60, 95% CI 1.16-2.19, p = 0.0037). Results suggest that in addition to previously reported risk factors, patient's subjective impressions of penile size negatively impacts sexual life in about 10% of men considered healthy, while objective penile length does not play significant role in erectile function.

Is there room for behavioral and modifiable health-related targets in the lower urinary tract symptoms' scenario.

PURPOSE: To better understand potential modifiable risk factors guiding preventive interventions against lower urinary tract symptoms (LUTS). METHODS: A prospective cross-sectional study, including healthy men aged 40-70 years under routine urological evaluation, measured the strength of association between the International Prostate Symptom Score (IPSS) and socio-demographic, lifestyle, and health-related factors using logistic and linear regression adjusted for confounding factors. Men with urethral or prostate surgery were excluded. RESULTS: Among 743 men, mean age 59.64 ± 9.66, 22.6% reported moderate, and 5.0% severe LUTS. The adjusted odds of severe LUTS increased with: increasing age (OR = 1.07, 95% CI = 1.05-1.09, p < .0001), increasing prostate volume (OR = 1.02, 95% CI = 1.01-1.04, p = .004), decreasing education (tertiary qualification, no versus yes, OR = 2.34; 95% CI = 1.16-4.70; p = .0133), delayed ejaculation (yes versus no, OR = 2.63, 95% CI = 1.43-4.83, p < .0001), and increasing blood pressure (systolic ≥130 mmHg, OR = 2.03, 95% CI = 1.44-2.86, p < .0001 or diastolic ≥85 mmHg, OR = 1.47, 95% CI = 1.03-2.10, p = .0345); severe LUTS decreased with: increasing the weekly sexual frequency (OR = 0.80, 95% CI = 0.69-0.91, p = .0012) and increasing HDL cholesterol (OR = 0.98, 95% CI = 0.97-0.99, p = .037). Odds were not significant for age of sexual initiation, precocious ejaculation, masturbatory pattern, physical activity, smoking, alcohol consumption, penile length (objective and subjective), abdominal circumference, obesity, comorbid conditions, metabolic syndrome, serum glycaemia, testosterone, SHBG, PSA, and estradiol. CONCLUSIONS: One in every four men under routine urological evaluation who considered themselves healthy present moderate and severe LUTS. Modifiable behavioral (education, sexual frequency, and ejaculation) and health-related (blood pressure and HDL cholesterol) targets were identified for future interventional studies and potential preventive actions and patient counseling.

Steroid Hormone Receptors as Potential Mediators of the Clinical Effects of Dutasteride: A Prospective, Randomized, Double-Blind Study.

This study characterizes the clinical and morphofunctional effects of a 5α-reductase inhibitor on steroid hormone receptors in normal human prostate tissue, as potential mediators of the clinical effects of dutasteride. This work was a prospective, double-blind, and randomized study that evaluated 49 men aged between 45 and 70 years, with no alterations in a digital rectal examination and prostate-specific antigen measurements between 2.5 and 4.0 ng/mL. These patients underwent prostate biopsy guided by transretal ultrasound with prostate neoplasia being ruled out, and the patients were divided into two groups, with one group receiving dutasteride ( n = 25) and one group receiving a placebo ( n = 24). The patients were clinically assessed each quarter, and at the end of 12 months they underwent new laboratory tests, prostate rebiopsy, and histopathological, immunohistochemical and clinical analyses. The estrogen receptor-beta (ERß) and androgen receptor immunoreactivities were higher, and the proliferation/apoptotic ratio was significantly lower with predominance of the apoptotic process, followed by a significant reduction in the prostate volume and the total serum prostate-specific antigen levels in the dutasteride group when compared with the placebo group, with a clear supremacy of ERß. There were no significant variations in the serum estrogen and testosterone levels, in the body mass index, or in the ERα immunoreactivities in the dutasteride and placebo groups. The results demonstrated the importance of the ERß pathway in the activation mechanisms of apoptosis, exerting a protective effect in the normal prostate, indicating that this receptor might be an important mediator of the clinical effects of dutasteride.

Is metabolic syndrome truly a risk factor for male lower urinary tract symptoms or just an epiphenomenon?

To define whether the association of male lower urinary tract symptoms (LUTS) and metabolic syndrome (MS) is real or simply an epiphenomenon, 490 male adults (mean age 58 ± 9 years) underwent International Prostate Symptom Score (IPSS), physical and prostate digital examinations, blood analysis, and urinary tract transabdominal ultrasound with prostate volume measurement. Mild, moderate, and severe LUTS were found in 350 (71.4%), 116 (23.7%), and 24 (4.9%) patients, respectively. MS was present in 198 (40.4%) patients, representing 37.4% (131 of 350) of those with mild LUTS, 46.5% (54 of 116) of those with moderate, and 54.1% (13 of 24) of those with severe. The odds ratio of MS having moderate or severe LUTS was 2.1. MS was more common in older age, higher body mass index, and larger prostate size. Moderate and severe LUTS were more frequent in older age, lower levels of high density cholesterol, and higher blood pressure. Older age and body mass index had significant relative risk for lower urinary tract symptoms and only age remained independent factor for LUTS on multivariate analysis. Our results suggest that the association of male LUTS, prostate volume, and MS might be coincidental and related to older age.

Experience with different botulinum toxins for the treatment of refractory neurogenic detrusor overactivity.

PURPOSE: To report our experience with the use of the botulinum toxin-A (BoNT/A) formulations Botox and Prosigne in the treatment of neurogenic detrusor overactivity (NDO). MATERIALS AND METHODS: At a single institution, 45 consecutive patients with refractory urinary incontinence due to NDO received a single intradetrusor (excluding the trigone) treatment with botulinum toxin type A 200 or 300 units. Botox was used for the first 22 patients, and Prosigne for the subsequent 23 patients. Evaluations at baseline and week 12 included assessment of continence and urodynamics. Safety evaluations included monitoring of vital signs, hematuria during the procedure, hospital stay, and spontaneous adverse event reports. RESULTS: A total of 42 patients were evaluated (74% male; mean age, 34.8 years). Significant improvements from baseline in maximum cystometric capacity (MCC), maximum detrusor pressure during bladder contraction, and compliance were observed in both groups (P < 0.05). Improvement in MCC was significantly greater with Botox versus Prosigne (+103.3% vs. +42.2%; P = 0.019). Continence was achieved by week 12 in 16 Botox recipients (76.2%) and 10 Prosigne recipients (47.6%; P = 0.057). No severe adverse events were observed. Mild adverse events included 2 cases of transient hematuria on the first postoperative day (no specific treatment required), and 3 cases of afebrile urinary tract infection. CONCLUSIONS: Botox and Prosigne produce distinct effects in patients with NDO, with a greater increase in MCC with Botox. Further evaluation will be required to assess differences between these formulations.

Experience with different botulinum toxins for the treatment of refractory neurogenic detrusor overactivity

Purpose: To report our experience with the use of the botulinum toxin-A (BoNT/A) formulations Botox® and Prosigne® in the treatment of neurogenic detrusor overactivity (NDO). Materials and methods: At a single institution, 45 consecutive patients with refractory urinary incontinence due to NDO received a single intradetrusor (excluding the trigone) treatment with botulinum toxin type A 200 or 300 units. Botox was used for the first 22 patients, and Prosigne for the subsequent 23 patients. Evaluations at baseline and week 12 included assessment of continence and urodynamics. Safety evaluations included monitoring of vital signs, hematuria during the procedure, hospital stay, and spontaneous adverse event reports. Results: A total of 42 patients were evaluated (74 percent male; mean age, 34.8 years). Significant improvements from baseline in maximum cystometric capacity (MCC), maximum detrusor pressure during bladder contraction, and compliance were observed in both groups (P < 0.05). Improvement in MCC was significantly greater with Botox versus Prosigne (+103.3 percent vs. +42.2 percent; P = 0.019). Continence was achieved by week 12 in 16 Botox recipients (76.2 percent) and 10 Prosigne recipients (47.6 percent; P = 0.057). No severe adverse events were observed. Mild adverse events included 2 cases of transient hematuria on the first postoperative day (no specific treatment required), and 3 cases of afebrile urinary tract infection. Conclusions: Botox and Prosigne produce distinct effects in patients with NDO, with a greater increase in MCC with Botox. Further evaluation will be required to assess differences between these formulations.