Efficacy of silodosin on the outcome of semi-rigid ureteroscopy for the management of large distal ureteric stones: blinded randomised trial.

OBJECTIVE: To evaluate the efficacy of silodosin therapy, as a new α-adrenergic receptor (α-AR) blocker, on the success rate of semi-rigid ureteroscopy (URS) for the management of large distal ureteric stones. PATIENTS AND METHODS: This prospective study recruited 127 adult patients with single distal ureteric stone of ≥1 cm. The patients were randomly allocated to two groups: the first group included 62 patients who received silodosin (8 mg) for 10 days before URS (Silodosin group), whilst the second group included 65 patients who received placebo, in the form of multivitamins, for 10 days before URS (Placebo group). All patients underwent URS and a pneumatic lithoclast was used for stone fragmentation. RESULTS: The mean (SD) operative time was shorter in the Silodosin group compared with the Placebo group, at 41.61 (4.67) vs 46.85 (4.6) min, respectively. Furthermore, advancing the ureteroscope to access the stone failed in a statistically significant number of patients in the Placebo group compared with the Silodosin group (13 vs two, respectively). The complication rate was significantly higher in the Placebo group compared with the Silodosin group (20% vs 6.4%, P = 0.036). Additionally, the need for postoperative analgesia was significantly lower in the Silodosin group compared with the Placebo group (8.1% vs 26.2%, P = 0.009). CONCLUSION: Silodosin therapy prior to URS management of large distal ureteric stones seems to be associated with better advancing of the ureteroscope to access the stone, shorter procedure time, higher stone-free rate, lower incidence of complications, and lesser need for postoperative analgesia.

Transurethral bipolar plasmakinetic vapo-enucleation of the prostate: Is it safe for patients on chronic oral anticoagulants and/or platelet aggregation inhibitors?

OBJECTIVES: To assess the safety and efficacy of bipolar plasmakinetic enucleation and resection of the prostate (PKERP) for the management of benign prostatic hyperplasia (BPH) in patients on oral anticoagulant (OAC) therapy and/or platelet aggregation inhibitors (PAIs). PATIENTS AND METHODS: In all, 91 patients were recruited and underwent PKERP whilst they were receiving PAIs (aspirin, 56 patients; clopidogrel, three; aspirin and clopidogrel, 11). In all, 15 patients were receiving an OAC drug perioperatively, whilst another six patients were on dual PAIs and OACs. The primary outcomes were the perioperative morbidity and mortality rates. The secondary outcomes were functional outcomes including maximum urinary flow rate (Qmax), International Prostate Symptoms Score (IPSS), and post-void residual urine volume (PVR). RESULTS: The mean (SD) age of the patients was 65 (5.9) years, preoperative adenoma volume was 80.9 (30.4) mL, and the operative time was 67 (23) min. No patient developed serious perioperative cardiovascular complications. The mean (SD) duration of hospital stay was 1.79 (1) days and the postoperative catheterisation time was 1.14 (0.76) days. The mean (SD) haemoglobin drop was 0.74 (0.61) g/dL, blood transfusion rate was 2.2%, and the clot retention rate was 2.2%. The mean (SD) postoperative Qmax was 18.6 (4.37) mL/s as compared to 7.2 (3.2) mL/s preoperatively (P < 0.001), and the preoperative IPSS was reduced from 24.3 (6.1) to 5.7 (2.3) postoperatively (P < 0.05). Prostate volume measured by transrectal ultrasonography was significantly reduced from a mean (SD) of 80.9 (30.4) mL preoperatively to 29.5 (10.6) mL postoperatively (P < 0.001). CONCLUSION: Minimally invasive PKERP may be considered as a safe and effective treatment option for managing patients with BPH receiving OAC/PAI drugs.

Bipolar Plasmakinetic Enucleoresection of the Prostate: Our Experience with 245 Patients for 3 Years of Follow-Up.

OBJECTIVE: The aim of this study was to evaluate the safety, feasibility, and effectiveness of bipolar transurethral plasmakinetic enucleation of the prostate (PKEP). PATIENTS AND METHODS: Between January 2010 and October 2013, 245 patients with lower urinary tract symptoms due to benign prostatic hyperplasia underwent transurethral enucleation of prostate using bipolar plasma vaporization energy. Patients were evaluated preoperatively by full detailed history, routine preoperative investigation digital rectal examination, serum prostate-specific antigen, abdominal and transrectal ultrasonography, and maximum flow rates (Qmax). RESULTS: Patients' ages ranged from 50 to 81 (65.5 ± 6) years with transrectal ultrasound-measured prostate volume of 97.1 ± 36.7 mL resulting in an operating time of 76.9 ± 27.9 minutes, and postoperative irrigation and catheterization times were 3.5 ± 3.2 and 12.7 ± 6.1 hours, respectively. No significant complication occurred intra- or postoperatively. Qmax increased from 7.1 ± 3.2 mL/second preoperative to 18.4 ± 4.2 mL/second (p < 0.001). The International Prostate Symptom Score decreased from 25 ± 6 to 7.9 ± 2.4 (p < 0.01). CONCLUSION: This study confirmed that PKEP is a safe, easy to learn, and durable technique suitable for any prostate sizes.

Enhancement of the aqueous solubility and masking the bitter taste of famotidine using drug/SBE-beta-CyD/povidone K30 complexation approach.

The objective of the present study was to evaluate the potential of ternary system (comprised of famotidine, beta-cyclodextrin (beta-CyD) or its derivatives and a hydrophilic polymer) as an approach for enhancing the aqueous solubility and masking the bitter taste of famotidine. The aqueous solubility of famotidine increased in the presence of beta-CyDs, particularly sulfobutyl ether beta-CyD (SBE-beta-CyD), and it was further enhanced by the combination of SBE-beta-CyD and polyvinyl pyrrolidone (Povidone) K30. The solid binary (drug-beta-CyDs) and ternary (drug-beta-CyDs-Povidone K30) systems were prepared by the kneading and freeze-drying methods. The dissolution rates of these solid systems were much faster than that of the drug alone. A taste perception study was carried out, initially using a taste sensory machine and subsequently on human volunteers to evaluate the taste masking ability of the ternary complexation. Our results indicated that the combination of SBE-beta-CyD and Povidone K30 is effective not only in the enhancement of the solubility and dissolution rate of famotidine, but also in masking of the bitter taste of the drug. This technique may be of value for the pharmaceutical industries, especially in preparation of rapidly disintegrating tablets dealing with bitter drugs to improve patient compliance and thus effective pharmacotherapy.

Evaluation of carboxymethyl-beta-cyclodextrin with acid function: improvement of chemical stability, oral bioavailability and bitter taste of famotidine.

The objective of the present study was to evaluate the potential influence of carboxymethyl-beta-cyclodextrin (CM-beta-CyD) on the aqueous solubility, chemical stability and oral bioavailability of famotidine (FMT) as well as on its bitter taste. We examined the effect of the CM-beta-CyD on the acidic degradation of FMT compared with that for sulfobutyl-ether-beta-cyclodextrin (SBE-beta-CyD). The potential use of CM-beta-CyD for orally disintegrating tablets (ODTs) was evaluated in vitro and in vivo. A taste perception study was also carried out. A strong stabilizing influence of CM-beta-CyD was observed against the acidic degradation, in sharp contrast to SBE-beta-CyD which induced a weird destabilizing effect on FMT. (13)C NMR was used to investigate the interaction mode between FMT and the 2 CyDs. In vivo study of ODTs indicated a significant increase in C(max), AUC and oral bioavailability in the case of FMT-CM-beta-CyD tablets, compared with plain drug tablets. However, no significant difference in T(max) and t(1/2) was observed. CM-beta-CyD complexation appears to be an acceptable strategy for enhancing the oral bioavailability of FMT owing to its dramatic effect on the aqueous solubility and chemical stability of the drug. In addition, it has a pronounced effect on masking the bitter taste of FMT.