The effects of pregabalin, solifenacin and their combination therapy on ureteral double-J stent-related symptoms: A randomized controlled clinical trial

ABSTRACT Background: Many medical therapies have been tested to deal with urinary stent-related symptoms (USRS). Several preventive and pharmaceutical methods have been already used for better compatibility of stents. However, the existing evidence for pharmacological treatment is still controversial. This study aims to evaluate the effects of pregabalin, solifenacin, and combination therapy on ureteral double-J stent-related symptoms following ureteroscopy and transureteral lithotripsy (TUL). Materials and methods: In a randomized controlled clinical trial, from November 2017 to March 2019, 256 patients who underwent ureteroscopy were enrolled. Patients were randomly divided into four groups including: group A received pregabalin 75mg BID (twice daily), group B received solifenacin 5mg orally once daily, group C received combination of pregabalin and solifenacin and the group D (control) given no drugs. Results: One hundred and fifty-one (58.9%) males and 101 (41.1%) females were enrolled in this study with a mean age of 43.47±7 (p=0.32, p=0.67). USSQ domains score such as urinary symptoms, pain, general condition, work performance, sexual matters and additional problems were significantly differenced during second and fourth week of follow-up among study groups (p <0.0001). In Tukey's multiple comparison test, urinary symptoms (p=0.735), pain (p=0.954) and sexual matters (p=0.080) in second week and work performance in forth week in group B was not significantly better than group D. Only group C in all indexes of USSQ showed significantly beneficial effects over group D (p <0.0001). Conclusion: Combination therapy of pregabalin and solifenacin has a significant effect on stent-related symptoms and is preferred over monotherapy of the respected medications.

The effects of pregabalin, solifenacin and their combination therapy on ureteral double-J stent-related symptoms: A randomized controlled clinical trial.

BACKGROUND: Many medical therapies have been tested to deal with urinary stent-related symptoms (USRS). Several preventive and pharmaceutical methods have been already used for better compatibility of stents. However, the existing evidence for pharmacological treatment is still controversial. This study aims to evaluate the effects of pregabalin, solifenacin, and combination therapy on ureteral double-J stent-related symptoms following ureteroscopy and transureteral lithotripsy (TUL). MATERIALS AND METHODS: In a randomized controlled clinical trial, from November 2017 to March 2019, 256 patients who underwent ureteroscopy were enrolled. Patients were randomly divided into four groups including: group A received pregabalin 75mg BID (twice daily), group B received solifenacin 5mg orally once daily, group C received combination of pregabalin and solifenacin and the group D (control) given no drugs. RESULTS: One hundred and fifty-one (58.9%) males and 101 (41.1%) females were enrolled in this study with a mean age of 43.47±7 (p=0.32, p=0.67). USSQ domains score such as urinary symptoms, pain, general condition, work performance, sexual matters and additional problems were significantly differenced during second and fourth week of follow-up among study groups (p <0.0001). In Tukey's multiple comparison test, urinary symptoms (p=0.735), pain (p=0.954) and sexual matters (p=0.080) in second week and work performance in forth week in group B was not significantly better than group D. Only group C in all indexes of USSQ showed significantly beneficial effects over group D (p <0.0001). CONCLUSION: Combination therapy of pregabalin and solifenacin has a significant effect on stent-related symptoms and is preferred over monotherapy of the respected medications.

Comparison of the outcomes of complete supine percutaneous nephrolithotomy in patients with radiopaque and radiolucent kidney stones.

OBJECTIVE: This study compared the stone opacity effect in patients who had radiopaque and radiolucent stones in percutaneous nephrolithotomy (PCNL) results. MATERIAL AND METHODS: The medical records of 171 complete supine PCNL procedures were gathered. Patients were categorized into two groups: those with radiopaque (n=141) and those with radiolucent (n=30) stones. Kidney, ureter and bladder x-ray was done a day after PCNL and Ultrasound imaging was done two weeks later to evaluate the stone free rate. A stone free result was defined as having less than 4 mm residual stone size. Outcome parameters were compared by univariate analysis and those which were significantly different between the two groups were assessed by multivariate binary logistic regression analysis. RESULTS: There were no significant differences in age, sex, body mass index, hypertension, diabetes mellitus, pre-surgery hemoglobin, pre-surgery serum creatinine, stone and also surgery-related parameters between the two groups. Stone free rate, surgery time, complication-related parameters, hemoglobin drop, serum creatinine and glomerular filtration rate (GFR) changes were similar in both groups based on univariate analysis. The radiopaque group had higher post-surgery GFR (p=0.04) and longer hospital stay (p=0.009). However, opacity had no effect on these outcomes after multivariate analysis. Higher post-surgery GFR was seen in patient with higher GFR before surgery (p<0.0001). Also, higher hemoglobin before surgery was correlated with less hospital stay (p=0.001). CONCLUSION: The complete supine percutaneous nephrolithotomy outcomes are similar in patients with radiopaque and radiolucent stones.

Intra-operative stone culture as an independent predictor of systemic inflammatory response syndrome after percutaneous nephrolithotomy.

To evaluate the correlation between preoperative urine culture and stone culture findings during PCNL and choosing the appropriate antimicrobial treatment of patients with urinary tract infection or SIRS after PCNL. From April 2007 to March 2008, 51 patients aged 24-66 years underwent PCNL under general anesthesia. Statistical analysis was performed using SPSS software (v.18), the Kolmogorov-Smirnov test, Student's t test, and the Chi square or Fisher's exact tests. Before operation, 11 patients (21.6 %) had positive urine culture. Sixteen patients (31.4 %) had positive stone culture during operation. SIRS occurred in 13 patients (25.5 %). In female group (10 cases, 45.5 %), SIRS was significantly higher than male group (3 cases, 10.3 %) (P = 0.008). Positive stone culture was significantly more prevalent in cases with positive pre-operative urine culture than cases with negative pre-operative urine culture (P = 0.023). But positive stone culture in group with SIRS, was significantly more common than group without SIRS (P = 0.001). Also positive stone culture in female group had significantly higher than male group (P = 0.003). We found a significant, tenfold increase in the risk of developing SIRS after PNCL, only in patients with positive stone culture (OR = 9.96; 95 % CI = 2.37-41.85, P = 0.002). Positive stone culture is a significant predictor of SIRS after PCNL, regardless of other related factors. Therefore, in order to avoid using blind empirical antibiotic regimen and to reduce the risk of subsequent microbial resistance due to use of prevalent broad-spectrum antibiotics, it would be wise to choose appropriate antibiotic therapy based on the results of intraoperative stone culture.

Comparative study of hemodynamics electrolyte and metabolic changes during prone and complete supine percutaneous nephrolithotomy.

BACKGROUND: Nowadays Percutaneous Nephrolithotomy (PCNL) is performed in prone and supine positions. Physiologic solutions should be used to irrigate during PCNL. Irrigation can cause hemodynamic, electrolyte and acid-base changes during PCNL. OBJECTIVES: The current study aimed to compare the electrolyte, hemodynamic and metabolic changes of prone and complete supine PCNL. PATIENTS AND METHODS: It was a randomized clinical trial study on 40 ASA class I and II patients. Twenty of patients underwent prone PCNL (Group A) and the other twenty underwent complete supine PCNL (Group B). The two groups received the same premedication and induction of anesthesia. Blood pressure (systolic, diastolic and mean) and pulse rate were recorded before, during and after anesthesia and Hb, Hct, BUN, Cr, Na, and K were also measured before and after operation in the two groups. The volume of irrigation fluid, total effluent fluid (the fluid in the bucket and the gazes) and volume of absorbed fluid were measured. RESULTS: There were no significant differences in Na, K, BUN, Cr, Hb and Hct between the two groups. Absorption volume was significantly different between the two groups (335 ± 121.28 mL in group A and 159.45 ± 73.81 mL in group B, respectively) (P = 0.0001). The mean anesthesia time was significantly different between the two groups (P = 0.012). There was a significant difference in bleeding volume between supine and prone PCNL (270.4 ± 229.14 in group A and 594.2 ± 290 in group B, respectively) (P = 0.0001). Mean systolic blood pressure during operation and recovery was 120.2 ± 10.9 and 140.7 ± 25.1 in group B, and 113.4 ± 6.4 and 126.2 ± 12.7 in group A, respectively. Systolic blood pressure between the two groups during operation and recovery was significantly different (P = 0.027 and P = 0.022, respectively). Mean diastolic blood pressure in supine group during operation and recovery was 80.53 ± 7.57 and 95.75 ± 17.48, and 73.95 ± 3.94 and 83.4 ± 12.54 in prone group, respectively. Diastolic blood pressure was significantly different between the two groups. It was 80.55 ± 7.57 and 95.75 ± 17.48, respectively during operation and recoveryin the supine group and 73.95 ± 3.94 and 83.4 ± 12.54 in the prone group, respectively (P = 0.001 and P = 0.014, respectively), but there was no significant difference between the pulse rate mean value of the two groups. CONCLUSIONS: The electrolyte and metabolic changes were not significantly different between the two groups, and although fluid absorption in prone group was more than that of the complete supine group, there was no significant difference between the two groups. Considering advantages of complete supine PCNL such as less hemodynamic changes (less hypotension, less fluid absorption and less duration of operation) this kind of PCNL was recommended.