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CONTEXT: Management of urolithiasis in patients with chronic kidney disease. AIMS: To ascertain the best method surgical or noninvasive. SETTINGS AND DESIGN: This was a single-institute study. SUBJECTS AND METHODS: A total of 50 patients of CKD with urolithiasis were enrolled in this comparative study. Clinical evaluation, biochemical evaluation, and radiological imaging were done. The management strategies were individualized to patient need. Following procedure, imaging and biochemical assessment were done to assess the stone clearance and improvement in the renal parameters. Intraoperative and postoperative complications are also noted. The patients were followed up to 6 months. STATISTICAL ANALYSIS USED: Statistical Package for the Social Sciences version 21.0 software was used for statistical analysis. RESULTS: The mean age of the patients was 55.22 ± 10.76 years (range 28-76). Majority were male (76%) and had unilateral involvement. The mean preoperative hemoglobin (Hb), urea, creatinine, and total leukocyte count (TLC) were 9.49 ± 0.84 g%, 71.13 ± 24.09 mg/dl, 4.71 ± 2.45 mg/dl, and 8.67 ± 1.81 thousands/cumm, respectively. Percutaneous nephrolithotomy (PCNL) and ureteroscopic lithotripsy (URSL) were the most common procedures performed in 23 (46%) and 12 (24%) patients, respectively. In 5 (10%) patients, PCNL with URSL was used. The clearance rate for different techniques ranged from 40% (PCNL with URSL) to 91.7% (URSL alone). The overall clearance rate was 78.3%. Fever (40%) and deranged renal function test requiring hemodialysis (16%) were the most common postoperative complications. Postoperatively, a significant decline in the mean Hb, serum (S.) urea, and S. creatinine was observed. The mean TLC levels showed a significant increase. During follow-up, S. creatinine levels showed consistent decline. Auxiliary procedures were needed in six (12%) cases. There were two (4%) mortalities. CONCLUSIONS: The management of urolithiasis among CKD patients requires individualized approaches. The selection of appropriate strategy results in good outcome and minimum complications.
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BACKGROUND: Evidence is lacking for multi-ingredient herbal supplements claiming therapeutic effect in sexual dysfunction in men. We examined the safety and efficacy of VigRX Plus (VXP) - a proprietary polyherbal preparation for improving male sexual function, in a double blind, randomized placebo-controlled, parallel groups, multi-centre study. METHODS: 78 men aged 25-50 years of age; suffering from mild to moderate erectile dysfunction (ED), participated in this study. Subjects were randomized to receive VXP or placebo at a dose of two capsules twice daily for 12 weeks. The international index of erectile function (IIEF) was the primary outcome measure of efficacy. Other efficacy measures were: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), Serum testosterone, Semen analysis, Investigator's Global assessment and Subjects' opinion. RESULTS: In subjects receiving VXP, the IIEF-Erectile Function (EF) scores improved significantly as compared to placebo. After 12 weeks of treatment, the mean (sd) IIEF-EF score at baseline increased from 16.08 (2.87) to 25.08 (4.56) in the VXP group versus 15.86 (3.24) to 16.47 (4.25) in the placebo group (P < 0.0001). Similar results were observed in each of the remaining four domains of the IIEF (orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction).There was a significant difference for VXP versus placebo comparison of mean (sd) EDITS scores of patients: 82.31(20.23) vs 36.78(22.53) and partners :(82.75(9.8) vs 18.50(9.44);P < 0.001. Thirty-five out of 39 (90%) subjects from the VXP group and one (3%) from the placebo group wished to continue with the treatment they received. Investigator's global assessment rated VXP therapy as very good to excellent in more than 50% patients and placebo therapy as fair to good in about 25% of patients. Incidence of side effects and subject's rating for tolerability of treatment was similar in both groups. CONCLUSIONS: VigRX Plus was well tolerated and more effective than placebo in improving sexual function in men. TRIAL REGISTRATION: Clinical Trial Registry India, CTRI/2009/091/000099, 31-03-2009.