Prospective two-arm study of the testicular function in patients with COVID-19.

BACKGROUND: The COVID-19 pandemic has led the international community to conduct extensive research into potential negative effects of the disease on multiple organs and systems in the human body. One of the most discussed areas is potential of the virus to compromise the testicular function. However, the lack of prospective studies on this topic makes it impossible to draw reliable conclusions on whether the disease affects the male reproductive system and, if so, to what extent. OBJECTIVES: The current trial is aimed at investigating the effect of SARS-CoV-2 on the testicular function, hormone levels and determining the extent of impact on spermatogenesis and damage to testicular tissue. MATERIALS AND METHODS: This prospective study included healthy controls and cases of patients suffering from viral pneumonia based on chest computed tomography (CT) and a positive SARS-CoV-2 throat swab exhibited moderate symptoms (World Health Organization (WHO) classification). Epidemiological, clinical, laboratory and ultrasound data were collected. A semen analysis was performed in cases during their hospital stay and 3 months after the discharge home. We also assessed the testicles obtained during autopsies of patients who died of COVID-19 (n = 20). RESULTS: A total of 88 participants were included (44 controls and 44 cases). Blood testosterone levels were significantly decreased in 27.3% of the cases (12/44). The mean level (7.3±2.7 nmol/L) was lower than that in the healthy controls (13.5±5.2 nmol/L, p < 0.001). An increase in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) was also detected compared to the healthy controls (p = 0.04 and p = 0.002). The semen analysis revealed decreased motility in COVID-19 patients (p = 0.001), and a higher number of immobile sperm (during COVID-19: 58.8% and at 3 months 47.4%, p = 0.005). All parameters returned to normal at 3 months after discharge. Direct mixed agglutination reaction (MAR) test at 3 months showed an increase of Ig A (p = 0.03). In the majority of autopsies (18/20), structural disorders of the testicular tissue, with signs of damage to germ cells were observed. DISCUSSION AND CONCLUSION: COVID-19 and its management strategies significantly affect male hormone levels and sperm quality at the onset of the disease. Postmortem examination of testicular tissue confirmed inflammation and viral infiltration of the testicles. However, in patients with moderate to severe disease, the studied parameters of the testicular function returned to normal values within 3 months.

A systematic review and meta-analysis of placebo effect in clinical trials on chronic prostatitis/chronic pelvic pain syndrome.

BACKGROUND: It is a common practice to control efficacy of pharmacological treatment with a placebo group. However, placebo itself may affect subjective and even objective results. The purpose of this study was to evaluate the placebo effect on symptoms of CP/CPPS to improve future clinical trials. METHODS: A search at three databases (Scopus, MEDLINE, and Web of Science) was conducted to identify double-blind placebo-controlled clinical trials on the treatment of CP/CPPS published until April 2021. The primary outcome - National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score. SECONDARY OUTCOMES: Qmax, PVR, IPSS, and prostate volume. RESULTS: A total of 3502 studies were identified. Placebo arms of 42 articles (5512 patients, median 31 patients) were included in the systematic review. Systematic review identified positive changes in the primary endpoint, meta-analysis of 10 articles found that NIH-CPSI total score results were significantly influenced by placebo, mean difference -4.2 (95% confidence interval [CI]: -6.31, -2.09). Mean difference of NIH-CPSI pain domain was -2.31 (95% CI: -3.4, -1.21), urinary domain -1.12 (95% CI: -1.62, -0.62), quality of life domain -1.67 (95% CI: -2.38, -0.96); p < 0.001 for all. In case of the objective indicator - Qmax, there were three articles included in the meta-analysis. Qmax mean change from baseline was 0.68 (95% CI: -0.85, 2.22, p = 0.38). Systematic review showed no significant changes in pain, measured by VAS or other scores, IPSS and PVR. CONCLUSIONS: Placebo significantly affected the subjective parameters (NIH-CPSI) and limitedly affected various other measurements of pain (visual analog scale, McGill pain questionnaire). There was no long-term effect on IPSS and objective measurements (Qmax, PVR). This study can be used in further clinical trials to develop general rules of CPPS treatment assessment.

Ex vivo study of Ho:YAG and thulium fiber lasers for soft tissue surgery: which laser for which case?

The goal of this study was to assess the ablation, coagulation, and carbonization characteristics of the holmium:YAG (Ho:YAG) laser and thulium fiber lasers (TFL). The Ho:YAG laser (100 W av.power), the quasi-continuous (QCW) TFL (120 W av.power), and the SuperPulsed (SP) TFL (50 W av.power) were compared on a non-frozen porcine kidney. To control the cutting speed (2 or 5 mm/s), an XY translation stage was used. The Ho:YAG was tested using E = 1.5 J and Pav = 40 W or Pav = 70 W settings. The TFL was tested using E = 1.5 J and Pav = 30 W or Pav = 60 W settings. After ex vivo incision, histological analysis was performed in order to estimate thermal damage. At 40 W, the Ho:YAG displayed a shallower cutting at 2 and 5 mm/s (1.1 ± 0.2 mm and 0.5 ± 0.2 mm, respectively) with virtually zero coagulation. While at 70 W, the minimal coagulation depth measured 0.1 ± 0.1 mm. The incisions demonstrated zero carbonization. Both the QCW and SP TFL did show effective cutting at all speeds (2.1 ± 0.2 mm and 1.3 ± 0.2 mm, respectively, at 30 W) with prominent coagulation (0.6 ± 0.1 mm and 0.4 ± 0.1 mm, respectively, at 70 W) and carbonization. Our study introduced the TFL as a novel efficient alternative for soft tissue surgery to the Ho:YAG laser. The SP TFL offers a Ho:YAG-like incision, while QCW TFL allows for fast, deep, and precise cutting with increased carbonization.

Postoperative medical treatment of lower urinary tract symptoms after benign prostatic hyperplasia surgery. Are we underestimating the problem?

PURPOSE OF REVIEW: The aim of this study was to determine whether well timed start of medical and surgical treatment of benign prostatic obstruction (BPO) influences the treatment's effectiveness and thus the patients' overall functional outcomes and quality of life. RECENT FINDINGS: Pharmacological therapy even in high-volume (>80 cm3) BPH typically begins with α-blockers sole and only subsequently are 5ARI added. Several studies showed that acute urinary retention (AUR) developed more frequently in men who suffered severe lower urinary tract symptoms (LUTS) and who did not start combination therapy immediately. Moreover, there are no strict criteria which determine the right time for performing surgery in patients with mild and moderate LUTS, especially when pharmacological therapy fails. However, sometimes, the surgery does not eliminate all the symptoms, as it deals effectively with BPO, but does not treat an overactive bladder. Also, data show that surgery should be performed as soon as possible and be more radical after the first episode of AUR. SUMMARY: A combination of α-blockers and 5ARI makes for a good starting point where the treatment of high volume BPH is concerned. Ideally, surgery should be performed immediately or as soon as possible in patients with the first episode of AUR and 'anatomic' BPH tissue removal is preferable (dissection of tissue along the prostate capsule to remove its maximum volume).

Acute kidney injury in COVID-19: are kidneys the target or just collateral damage? A comprehensive assessment of viral RNA and AKI rate in patients with COVID-19.

PURPOSE OF REVIEW: To investigate the possible effects of severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) on kidney function and assess the rate of viral ribonucleic acid (RNA) shedding/detection in urine. RECENT FINDINGS: Most of the research on the topic suggests that for the moment our ability to estimate whether SARS-CoV-2 is a direct causative agent in acute kidney injury (AKI) or whether it has a cytokine storm effect is limited. During our prospective assessment of 333 patients with COronaVIrus Disease 2019 (COVID-19) it was found that frequency of AKI of 9.6% (32 cases). Despite previous data suggestive of the ability to detect SARS-CoV-2 in urine, we were unable to identify any traces of messenger ribonucleic acid (mRNA) in our group. Both COVID-19 severity (odds ratio, OR = 23.09, confidence interval, CI 7.89-67.57, P < 0.001) and chronic kidney disease (CKD) history (OR = 7.17, CI 2.09-24.47, P = 0.002) were associated with the AKI rate. SUMMARY: AKI is a relatively frequent condition for patients with COVID-19 and is normally correlated with the severity of the disease and the patient's history of CKD. The available data fail to address whether SARS-CoV-2 mRNA is present in urine, whereas our prospective trial data suggest that mRNA is undetectable in urine irrespective of the severity of the disease.

Superselective prostatic artery embolization in the treatment of large benign prostatic hyperplasia.

PURPOSE: To evaluate the use of prostatic artery embolization (PAE) as a treatment option for patients with symptomatic benign prostatic hyperplasia (BPH) with prostate volumes of 80 cc and more. MATERIALS AND METHODS: The study included 75 patients with high anesthesia-related risks for conventional surgery (TURP). All patients were surveyed for symptom burden, using IPSS and quality of life score. The prostate volume was determined by transrectal ultrasonography (TRUS). At baseline, prostate-specific antigen (PSA) level was obtained in all patients. Urodynamics was evaluated using uroflowmetry. Clinical outcomes were assessed at follow-up 1, 3, 6, 12, and 24 months after PAE. RESULTS: The prostate volume decreased significantly at months 1 and 3 post-treatment; the prostate continued shrinking until month 12, and the size was then stabilized. At month 24, prostate volume decreased by 40.82%, from 134.0 ± 8.3 mL at baseline to 79.3 ± 6.6 mL. Postvoid residual (PVR) urine volume was significantly decreased from 55.9 ± 5.3 mL to 22.0 ± 1.8 mL 1 month after PAE (p < 0.001). Qmax increased from 9.2 ± 0.3 mL/s to 15.7 ± 0.4 mL/s. IPSS score following PAE decreased from 28.2 ± 0.7 to 9.7 ± 0.8 (p < 0.001). QoL improvement was observed from 4.8 ± 0.2 at baseline to 1.8 ± 0.2 at month 24 (p < 0.001). Decreased activity and density of adenomatous tissue resulted in decreased total PSA levels: from 5.9 ± 1.1 ng/mL to 2.6 ± 0.2 ng/mL (p < 0.001). TURP became feasible in 35 patients due to reduction of prostate volumes below 80 mL after PAE. CONCLUSIONS: PAE was effective in relieving LUTS and reducing prostate size, and may be considered as a preoperative approach for patients with large prostate.

Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction in Diabetic Patients.

INTRODUCTION: The cause of erectile dysfunction (ED) in diabetic patients is complex and involves both neurogenic and vasculogenic components and is often hard to treat. AIM: To study the effect of low-intensity extracorporeal shock wave therapy (Li-ESWT) therapy on a subgroup of diabetic patients with ED who are responders (PDE5I-R) and non-responders (PDE5I-NR) to phosphodiesterase 5 inhibitors (PDE5I). METHODS: Analysis of pooled data from 5 double-blind, sham-controlled trials was performed. In this sub-analysis, of 350 patients in the PDE5I-R group and with vasculogenic ED, we found 61 patients with diabetes mellitus who underwent LI-ESWT. Another 48 patients (of 53) belonged to the PDE5I-NR group. Baseline efficacy was evaluated with the International Index of Erectile Function-Erectile Function domain questionnaire (IIEF-EF) for the PDE5I-R and with Erection Hardness Score, IIEF-EF, and flow-mediated dilation technique for the PDE5I-NR. MAIN OUTCOME MEASURES: Change in the IIEF-EF score after treatment of diabetes-induced ED with Li-ESWT in the PDE5i-R group vs the PDE5i-NR group. RESULTS: LI-ESWT therapy was found to be effective in both subgroups of diabetic patients. Minimally clinical important difference in IIEF-EF score was achieved in 50%, 79.5%, 77.3%, and 65.9% of the subjects in the active group in after the sixth shockwave (SW) treatment evaluation (just before initiating the seventh SW session) and at 1 month, 6 months, and 12 months after the last SW treatment, respectively. The difference among the groups was significant (P < .05) after the sixth treatment and in all the follow-up periods. In the PDE5I-NR group, 55% of the active group were converted to PDE5I-5-R after LI-ESWT. The difference between the active and sham groups was statistically significant in all the tested measures (P < .001). CONCLUSION: LI-ESWT is safe and effective for the treatment of ED in PDE5I-R and PDE5I-NR groups. Spivak L, Shultz T, Appel B, et al. Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction in Diabetic Patients. Sex Med Rev 2021;9:619-627.

15 years' survey of safety and efficacy of Serenoa repens extract in benign prostatic hyperplasia patients with risk of progression.

AIM:: The aim of this study is to investigate the efficacy and safety of long-term therapy with Serenoa repens extract with regard to halting benign prostatic hyperplasia progression. MATERIAL AND METHODS:: An open non-comparative observational study of the continuous use of S. repens plant extract at a dosage of 320 mg once a day for 15 years was performed in 30 patients at risk for benign prostatic hyperplasia progression. Changes in IPSS (International Prostatic Symptoms Scale) and QoL (Quality of life) scores and changes in Qmax, voided volume, residual urine volume, and prostate volume were evaluated during the study. RESULTS:: The study showed an absence of progression based on both subjective (the sum of scores on the IPSS and QoL scales) and objective (prostate volume, urination rate, residual urine volume) criteria. Furthermore, the patients had no adverse events related to the study drug, including prostate cancer. CONCLUSIONS:: The 15 years' study results suggest that taking S. repens plant extract continuously at a daily dose of 320 mg is an effective and safe way to prevent the progression of benign prostatic hyperplasia.

A Randomized Trial Comparing The Learning Curve of 3 Endoscopic Enucleation Techniques (HoLEP, ThuFLEP, and MEP) for BPH Using Mentoring Approach-Initial Results.

OBJECTIVE: To assess the differences in the learning curve associated with different techniques of endoscopic enucleation of the prostate. MATERIALS AND METHODS: Ninety patients were randomly assigned into 3 groups (30 patients in each): HoLEP, ThuFLEP or MEP. Inclusion criteria for the study included prostate volume <80 cc, IPSS > 20, or Qmax < 10. The EEPs were performed by 3 surgeons experienced in transurethral resection of the prostate. Assignment of surgeons to surgical technique was also randomized. None of the surgeons had prior experience in EEP. RESULTS: ThuFLEP was slightly superior (with no significant difference [P > .05]) to HoLEP and MEP in terms of overall enucleation rate-1.0 g/min vs 0.8 g/min and 0.7 g/min, respectively. We observed similar enucleation rates at the initial stages of training (first 20 surgeries) with insignificant increase in ThuFLEP efficiency. At next 10 surgeries ThuFLEP and HoLEP efficiency were higher than of MEP (P < .001) without significant difference between techniques of laser EEP (P = .07). CONCLUSION: Endoscopic enucleation of the prostate can be adopted safely and effectively within 30 surgeries if the technique is learned with a mentoring approach. EEP is shown to be safe and effective even in the initial stages of learning. Laser EEP (HoLEP, ThuFLEP) appears to lend itself to quicker adaptation compared MEP.

Efficacy and safety of Afalaza in men with symptomatic benign prostatic hyperplasia at risk of progression: a multicenter, double-blind, placebo-controlled, randomized clinical trial.

INTRODUCTION: In order to investigate the efficacy and safety of Afalaza in men with benign prostatic hyperplasia (BPH) at risk of progression, this multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Derived by technological treatment of antibodies to prostate-specific antigen (PSA) and endothelial nitric oxide synthase (eNOs), Afalaza was previously proved to modulate its molecular targets. The mechanism of action of the drug is associated with the modulating effect of the antibiodies (RA-Abs) on the molecular targets (PSA and eNOS) by way of conformational changes. MATERIAL AND METHODS: A total of 49 patients aged 45-60 years with BPH and moderate lower urinary tract symptoms (LUTS), total prostate volume (TPV) ≥30 cm3, Qmax 10-15 ml/s, and serum PSA<4 ng/ml were randomly assigned to receive either Afalaza (n = 125) or placebo (n = 124) for 12 months. Changes in BPH/LUTS symptoms (according to the International Prostate Symptom Score), Qmax, TPV, PSA, BPH clinical progression, occurrence of acure urinary retention (AUR) events or BPH-related surgery were estimated as the study endpoints. RESULTS: IPSS mean change was -3.7 ±3.0 (95% CI -4.3 to -3.2) after 12 months of Afalaza (vs. -2.9 ±2.4; 95% CI -3.3 to -2.4 in placebo; р = 0.02). Qmax growth was 2.5 ±4.3 ml/s (vs. 1.4 ±3.3 in placebo; p = 0.049), TPV reduced by 11.8 ±16.0% (vs. 6.5 ±14.7%; p = 0.01, and PSA remained unchanged. Afalaza therapy resulted in a significant decrease in the total sum of BPH progression symptoms (p = 0.01). The maximum effect of Afalaza was registered after 12 months without a tendency to form a 'plateau'. During the study, no patients experienced AUR or BPH-related surgery. CONCLUSIONS: A 12-month course of Afalaza therapy is effective and safe for patients with BPH. The results of end points measurements revealed asignificant advantage of Afalaza compared to placebo in the overall symptoms benefit and a decline in the risk of BPH progression.ClinicalTrials.gov: NCT01716104.