Single Instillation of Hypertonic Saline Immediately Following Transurethral Resection of Bladder Tumor for Recurrence Prevention –A Phase I Study

2021 ◽  
pp. 1-6
Author(s):  
Jonathan Modai ◽  
Alexey Kovalyonok ◽  
Avigdor Scherz ◽  
Dina Preise ◽  
Yuval Avda ◽  
...  
Keyword(s):  
Adverse Events ◽  
Hypertonic Saline ◽  
Serum Sodium ◽  
Transurethral Resection ◽  
Bladder Tumor ◽  
Osmotic Dehydration ◽  
Control Group ◽  
Plasma Sodium ◽  
Pelvic Cavity ◽  
Blue Discoloration

BACKGROUND: Urologic guidelines recommend perioperative instillation of chemotherapy after transurethral resection of bladder tumor (TURBT) to decrease tumor recurrence, yet implementation of this recommendation is partial due to associated morbidity. Hypertonic saline destroys cells by osmotic dehydration and might present a safer alternative. OBJECTIVE: To evaluate the safety of 3% hypertonic saline (Hypersal) intravesical instillation following TURBT in rats and in humans. METHODS: In 8 rats whose bladders were electrically injured, intravesical blue-dyed Hypersal was administered. We measured serum sodium levels before and after instillation and pathologically evaluated their pelvic cavity for signs of inflammation or blue discoloration. Twenty-four patients were recruited to the human trial (NIH-NCT04147182), 15 comprised the interventional and 10 the control group (one patient crossed over). Hypersal was given postoperatively. Serum sodium was measured before, 1 hour and 12–24 hours after instillation. Adverse effects were documented and compared between the groups. RESULTS: In rats, average sodium levels were 140.0 mEq/L and 140.3 mEq/L before and following instillation, respectively. Necropsy revealed no signs of inflammation or blue discoloration. In humans the average plasma sodium levels were 138.6 mEq∖L, 138.8 mEq∖L and 137.7 mEq∖L before, 1 hour and 12–24 hours after instillation, respectively. During the postoperative follow-up there was one case of fever. A month after the surgery, dysuria was reported by 5 patients while urgency and hematuria were reported by one patient each. The most severe adverse events were grade 2 on the Clavien-Dindo scale. Adverse events were similar in the control group. CONCLUSIONS: Hypersal instillation is safe and tolerable immediately after TURBT.

scholarly journals Induced hypernatremia in patients with moderate-to-severe ARDS: a randomized controlled study

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Shailesh Bihari ◽  
Shivesh Prakash ◽  
Dani L. Dixon ◽  
Elena Cavallaro ◽  
Andrew D. Bersten
Keyword(s):  
Lung Injury ◽  
Hypertonic Saline ◽  
Fluid Management ◽  
Hospital Length Of Stay ◽  
Lung Injury Score ◽  
Controlled Study ◽  
Lung Protective Ventilation ◽  
Control Group ◽  
Plasma Sodium ◽  
Point Reduction

Abstract Background Induced hypernatremia and hyperosmolarity is protective in animal models of lung injury. We hypothesized that increasing and maintaining plasma sodium between 145 and 150 mmol/l in patients with moderate-to-severe ARDS would be safe and will reduce lung injury. This was a prospective randomized feasibility study in moderate-to-severe ARDS, comparing standard care with intravenous hypertonic saline to achieve and maintain plasma sodium between 145 and 150 mmol/l for 7 days (HTS group). Both groups of patients were managed with lung protective ventilation and conservative fluid management. The primary outcome was 1-point reduction in lung injury score (LIS) or successful extubation by day 7. Results Forty patients were randomized with 20 in each group. Baseline characteristics of severity of illness were well balanced. Patients in the HTS group had higher plasma sodium levels during the first 7 days after randomization when compared with the control group (p = 0.04). Seventy five percent (15/20) of patients in the HTS group were extubated or had ≥ 1-point reduction in LIS compared with 35% (7/20) in the control group (p = 0.02). There was also a decrease in length of mechanical ventilation and hospital length of stay in the HTS group. Conclusion We have shown clinical improvement in patients with moderate-to-severe ARDS following induced hypernatremia, suggesting that administration of hypertonic saline is a safe and feasible intervention in patients with moderate-to-severe ARDS. This suggests progress to a phase II study. Clinical Trial Registration Australian and New Zealand Clinical Trials Registry (ACTRN12615001282572)

Feedback control of vasopressin and corticotrophin secretion in conscious dogs: effect of hypertonic saline

1989 ◽  
Vol 122 (1) ◽  
pp. 41-48 ◽  
Author(s):  
H. Raff ◽  
M. M. Skelton ◽  
A. W. Cowley
Keyword(s):  
Hypertonic Saline ◽  
Negative Feedback ◽  
Plasma Cortisol ◽  
Isotonic Saline ◽  
Significant Inhibition ◽  
Saline Control ◽  
Feedback Signal ◽  
Control Group ◽  
Plasma Sodium ◽  
Plasma Acth

ABSTRACT Glucocorticoids are known to inhibit the ACTH response to a variety of stimuli. It has been suggested that vasopressin secretion is also inhibited by glucocorticoid negative feedback. The purpose of this study was to (1) determine the ACTH response to hypertonic saline and its sensitivity to glucocorticoid negative feedback and (2) to determine whether physiological elevations of plasma cortisol inhibit subsequent vasopressin responses to hypertonic saline. Five mongrel dogs (15–18 kg) were prepared with chronic arterial and venous catheters and studied while conscious. Ten experiments were performed on each dog in a randomized design separated by at least 5 days. Each experiment consisted of a pretreatment period (from −60 to −30 min except for dexamethasone administration) during which a glucocorticoid feedback signal was applied and a stimulus period (from 0 to 30 min) during which hypertonic saline was infused. The pretreatment and stimulus periods were separated by 30 min. Pretreatments were as follows: isotonic saline (control), half-maximal and maximal cortisol infusion (5·5 or 11 nmol/kg per min), ACTH(1–24) infusion (6·8 pmol/kg per min) which produces increases in endogenous cortisol, and dexamethasone (1·5 mg i.m.) given at 17.00 h the day before experimentation. Stimuli were as follows: hypertonic saline was infused at 0·2 or 0·4 mmol/kg per min which increased plasma sodium by about 6 or 12 mmol/l respectively. NaCl infusion at 0·2 mmol/kg per min had no effect on plasma ACTH or cortisol except when subsequent to ACTH(1–24) pretreatment when plasma ACTH actually increased to 41·4 ± 2·9 pmol/l in response to hypertonic saline. NaCl infusion at 0·4 mmol/kg per min resulted in a significant increase in plasma ACTH from 5·9 ± 0·9 to 11·7 ± 2·0 pmol/l in the control group. This ACTH response was blocked by pretreatment with either dose of cortisol and dexamethasone. ACTH pretreatment, however, did not completely block the ACTH subsequent response to infusion of 0·4 mmol NaCl/kg per min. The two doses of NaCl led to significant and dose-related increases in plasma vasopressin. None of the pretreatments significantly affected the vasopressin response to hypertonic saline except for significant inhibition after overnight dexamethasone. We conclude that (1) hypertonic saline can stimulate ACTH release if plasma sodium is increased sufficiently, (2) the ACTH response to hypertonic saline is potentiated by pretreatment with ACTH making it different from other stimuli studied previously, and (3) the vasopressin response to hypertonic saline is not inhibited by short-term elevations of plasma cortisol within the physiological range. Journal of Endocrinology (1989) 122, 41–48

scholarly journals A Comparative Study on the Therapeutic Effect of en Bloc Transurethral Resection of Bladder Tumors with Needle Electrode and Traditional Transurethral Resection of Bladder Tumor on Non-Muscle Invasive Bladder Tumor

2020 ◽  
Author(s):  
Jiashuo Li ◽  
Panfeng Shang ◽  
Yidi He ◽  
Yichao Shang ◽  
Xu Zheng
Keyword(s):  
Recurrence Rate ◽  
Transurethral Resection ◽  
Bladder Tumor ◽  
Control Group ◽  
Bladder Tumors ◽  
En Bloc ◽  
Factors Affecting ◽  
Surgical Safety ◽  
Kaplan Meier ◽  
Muscle Invasive

Abstract Background: En bloc transurethral resection of bladder tumors (ERBT) as an improved method of traditional transurethral resection of bladder tumor (TURBT), has not been standardized. The purpose of this study is to evaluate the safety and effectiveness of the technology.Methods: We divide non-muscle invasive bladder cancer into an experimental group receiving ERBT and a control group receiving traditional TURBT, and compared the recurrence rate by Kaplan-Meier curve adjusted by propensity score matching (PSM) analysis. In addition, we analyzed the independent risk factors affecting the recurrence rate of NMBIC by COX risk regression.Discussion: Compared with traditional transurethral resection of bladder tumor treatment, En bloc transurethral resection of bladder tumors has less intraoperative bleeding and high surgical safety. Moreover, this technique can obtain high-quality pathological specimens, which has obvious advantages in postoperative pathological assessment.

scholarly journals Magnesium and Bladder Discomfort after Transurethral Resection of Bladder Tumor

2020 ◽  
Vol 133 (1) ◽  
pp. 64-77 ◽  
Author(s):  
Jun-Young Park ◽  
Jun Hyuk Hong ◽  
Doo-Hwan Kim ◽  
Jihion Yu ◽  
Jai-Hyun Hwang ◽  
...  
Keyword(s):  
Smooth Muscle ◽  
Patient Satisfaction ◽  
Relative Risk ◽  
Adverse Effects ◽  
Transurethral Resection ◽  
Bladder Tumor ◽  
Absolute Risk ◽  
Smooth Muscle Relaxation ◽  
Control Group ◽  
Number Needed To Treat

Background Catheter-related bladder discomfort occurs because of involuntary contractions of the bladder smooth muscle after urinary catheterization. Magnesium is associated with smooth muscle relaxation. This study hypothesized that among patients having transurethral resection of bladder tumor, magnesium will reduce the incidence of postoperative moderate-to-severe catheter-related bladder discomfort. Methods In this double-blind, randomized study, patients were randomly allocated to the magnesium group (n = 60) or the control group (n = 60). In magnesium group, a 50 mg/kg loading dose of intravenous magnesium sulfate was administered for 15 min, followed by an intravenous infusion of 15 mg · kg−1 · h−1 during the intraoperative period. Patients in the control group similarly received normal saline. The primary outcome was the incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively. None, mild, moderate, and severe catheter-related bladder discomfort at 1, 2, and 6 h postoperatively, patient satisfaction, and magnesium-related adverse effects were also assessed. Results The incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively was significantly lower in the magnesium group than in the control group (13 [22%] vs. 46 [77%]; P < 0.001; relative risk = 0.283; 95% CI, 0.171 to 0.467; absolute risk reduction = 0.55; number needed to treat = 2); similar results were observed for catheter-related bladder discomfort above a moderate grade at 1 and 2 h postoperatively (5 [8%] vs. 17 [28%]; P = 0.005; relative risk = 0.294; 95% CI, 0.116 to 0.746; and 1 [2%] vs. 14 [23%]; P < 0.001; relative risk = 0.071; 95% CI, 0.010 to 0.526, respectively). Patient satisfaction on a scale from 1 to 7 was significantly higher in the magnesium group than in the control group (5.1 ± 0.8 vs. 3.5 ± 1.0; P < 0.001; 95% CI, 1.281 to 1.919). Magnesium-related adverse effects were not significantly different between groups. Conclusions Magnesium reduced the incidence of catheter-related bladder discomfort above a moderate grade and increased patient satisfaction among patients having transurethral resection of bladder tumor. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

Comparison of Endoscopic Versus Percutaneous Approach (Blind) to Control the Obturator Jerk in Patients Undergoing Transurethral Resection of Bladder Tumors Under Spinal Anesthesia

2020 ◽  
Vol 21 (2) ◽  
pp. 120-126
Author(s):  
Alamgir Md ◽  
Karim Km Monwarul ◽  
Nandy SP ◽  
Md Monwar Ul Haque ◽  
Sakhawat Mahmud Khan
Keyword(s):  
Statistical Analysis ◽  
Spinal Anesthesia ◽  
Transurethral Resection ◽  
Bladder Tumor ◽  
Complete Resection ◽  
Satisfaction Level ◽  
Bladder Tumors ◽  
Percutaneous Approach ◽  
Group A ◽  
Group B

Objective: The aim of the study was to compare the endoscopic versus percutaneous approach (blind) to control the obturator jerk in patients undergoing transurethral resection of bladder tumors under spinal anesthesia. Materials and methods: A prospective observational study was performed in Department of Urology, Chittagong Medical College, Chittagong and some Private Hospitals (Ltd.) in Chittagong city during the period from January 2016 to June 2016. Total 100 patients were grouped into two, on alternate basis. Fifty(50) patients in group- A conducted with endoscopic infiltration with 20ml of injection 2% lignocaine at the bladder tumor base and another 50 patients in group-B, conducted with blind percutaneous technique with same drug and volume ( 20ml inj.2% lignocaine) to control obturator jerk. Severity of obturator jerk in both procedure, percentage of complete resection, ONB procedure related time, ONB procedure related complications and surgeon’s satisfaction level were recorded and compared between two approaches. Chi-square analysis was performed to compare the ease of approach and outcome of the two techniques. A value of P<0.05 was considered statistically significant. Results: The mean age of the patients were 59.44+7.681. In group-A, 50 patients were given inj. 2% lignocaine endoscopically at the bladder tumor base to control obturator jerk. Twenty five patients (50%) had no jerk, 20 patients(40%) developed mild jerk and 5 patients (10%) developed moderate jerk and no patients developed severe jerk. Second attempt was taken in moderate jerk patients (5 patients) and succeeded in 3(6%) patients. So, in this group, complete resection of bladder tumor was possible in 96%. In group B, complete resection of bladder tumor was possible in 84%. Statistical analysis was done and result is significant in case of endoscopic procedure to control obturator jerk(p<0.05). ONB Procedure related time was <20 mins. in 32(64%) patients in group-A and 45 (90%) patients in group- B. 20 mins. or more time was required for 18 (36%) patients in group-A and 5 (10%) patients in group-B. Statistical analysis was done and result is significant in percutaneous (blind) technique (p<0.05). ONB procedure related complications in group-A and Group –B were noted. Statistical analysis was done and result is insignificant (p>0.05). Surgeons satisfaction level were recorded on the basis of obturator jerk block and complete resection and which was statistically significant in favour of endoscopy group (p<0.05). Conclusion: It is concluded that endoscopic injection of 2% lignocaine into the bladder tumor base is better in case of jerk elimination and complete resection than blind percutaneous approach. Though, ONB procedure related time was significantly less in percutaneous group. Bangladesh Journal of Urology, Vol. 21, No. 2, July 2018 p.120-126

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

An Internet-based health gateway device for interactive communication and automatic data uploading: Clinical efficacy for type 2 diabetes in a multi-centre trial

2016 ◽  
Vol 23 (6) ◽  
pp. 595-604 ◽  
Author(s):  
Jae Hyoung Cho ◽  
Hun-Sung Kim ◽  
Seung Hyun Yoo ◽  
Chang Hee Jung ◽  
Woo Je Lee ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthcare System ◽  
Glucose Control ◽  
Large Scale ◽  
Diabetes Management ◽  
Intervention Group ◽  
Diabetes Control ◽  
Control Group ◽  
Anthropometric Parameters ◽  
Automatic Data

Introduction The aim of this study was to improve the quality of diabetes control and evaluate the efficacy of an Internet-based integrated healthcare system for diabetes management and safety. Methods We conducted a large-scale, multi-centre, randomized clinical trial involving 484 patients. Patients in the intervention group ( n = 244) were treated with the Internet-based system for six months, while the control group ( n = 240) received the usual outpatient management over the same period. HbA1c, blood chemistries, anthropometric parameters, and adverse events were assessed at the beginning of the study, after three months, and the end of the study. Results There were no initial significant differences between the groups with respect to demographics and clinical parameters. Upon six-month follow-up, HbA1c levels were significantly decreased from 7.86 ± 0.69% to 7.55 ± 0.86% within the intervention group ( p < 0.001) compared to 7.81 ± 0.66% to 7.70 ± 0.88% within the control group. Postprandial glucose reduction was predominant. A subgroup with baseline HbA1c higher than 8% and good compliance achieved a reduction of HbA1c by 0.8 ± 1.05%. Glucose control and waist circumference reduction were more effective in females and subjects older than 40 years of age. There were no adverse events associated with the intervention. Discussion This e-healthcare system was effective for glucose control and body composition improvement without associated adverse events in a multi-centre trial. This system may be effective in improving diabetes control in the general population.

En bloc transurethral resection of bladder tumor: A review of the literature

2021 ◽  
pp. 205141582199373
Author(s):  
Jonathan Kopel ◽  
Pranav Sharma
Keyword(s):  
Bladder Cancer ◽  
Transurethral Resection ◽  
Bladder Tumor ◽  
Clinical Stage ◽  
Surgical Techniques ◽  
Cancer Recurrence ◽  
En Bloc ◽  
Level Of Evidence ◽  
Alternative Technologies ◽  
Bladder Cancer Recurrence

Bladder cancer remains one of the most common malignancies of the genitourinary tract. Transurethral resection of the bladder tumor (TURBT) via cystoscopy with examination under anesthesia remains the primary method for determining the diagnosis and clinical stage of bladder cancer. Given the substantial cost of treatment and risk of bladder cancer recurrence after TURBT, novel approaches to transurethral resection, such as the en bloc technique, have been developed in an attempt to address these limitations. In this review, we examined the postoperative and oncological outcomes of en bloc TURBT compared to traditional resection techniques. Further prospective clinical studies, however, are still necessary to determine whether these alternative technologies or surgical techniques may improve treatment in bladder cancer patients. Level of evidence: Not applicable.

EXPRESS: Altering the rehabilitation environment to improve stroke survivor activity (AREISSA): a Phase II trial.

2021 ◽  
pp. 174749302110069
Author(s):  
Heidi Janssen ◽  
Louise Ada ◽  
Sandy Middleton ◽  
Michael Pollack ◽  
Michael Nilsson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Outcomes ◽  
Environmental Enrichment ◽  
Brain Plasticity ◽  
Social Activity ◽  
Stroke Survivor ◽  
Group Differences ◽  
Control Group ◽  
Serious Adverse Events ◽  
Clinical Trial Registration

Background: Environmental enrichment involves organisation of the environment and provision of equipment to facilitate engagement in physical, cognitive and social activity. In animals with stroke, it promotes brain plasticity and recovery. Aims: To assess the feasibility and safety of a patient-driven model of environmental enrichment incorporating access to communal and individual environmental enrichment. Methods: A non-randomised cluster trial with blinded measurement involving people with stroke (n=193) in 4 rehabilitation units was carried out. Feasibility was operationalised as activity 10 days after admission to rehabilitation and availability of environmental enrichment. Safety was measured as falls and serious adverse events. Benefit was measured as clinical outcomes at 3 months, by an assessor blinded to group. Results: The experimental group (n=91) spent 7% (95% CI -14 to 0) less time inactive, 9% (95% CI 0 to 19) more time physically, and 6% (95% CI 2 to 10) more time socially active than the control group (n=102). Communal environmental enrichment was available 100% of the time, but individual environmental enrichment was rarely within reach (24%) or sight (39%). There were no between-group differences in serious adverse events or falls at discharge or 3 months nor in clinical outcomes at 3 months. Conclusions: This patient-driven model of environmental enrichment was feasible and safe. However, the very modest increase in activity by people with stroke, and the lack of benefit in clinical outcomes 3 months after stroke do not provide justification for an efficacy trial. Clinical Trial Registration: ANZCTR 12613000796785 Words: 245

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