Active clinical trials for "Urinary Calculi"

Urolithiasis is a disease that effects 12% of the population and its incidence is growing. In the US there are over 1.1 million visits annually to Emergency Departments for renal colic. The disease is extremely painful, often requiring large amounts of narcotic analgesia, and results in lost work days. Moreover, up to 30% of patients may eventually require lithotripsy or surgical removal of the stone. Currently there are no medical interventions other than analgesia which are offered to patients. Based on encouraging results from several small European clinical studies, the researchers hypothesize that the administration of tamsulosin to patients with symptomatic urolithiasis will enhance stone passage, and reduce both the time to recovery and the need for surgical intervention or lithotripsy. The researchers will conduct a study by identifying and recruiting patients presenting with urolithiasis in the emergency departments of four institutions. A total of 500 consenting subjects will be randomly assigned to one of two groups: tamsulosin for a maximum of 28 days; placebo for a maximum of 28 days. In addition, both groups will receive standard analgesic therapy. The study team, which will be blinded to treatment status, will monitor each subject's clinical progress and outcome. The primary objectives of this study are: to determine if tamsulosin is effective, and to evaluate the safety of the therapy. Another objective is to identify the most appropriate clinical subgroup(s) for treatment. If the therapeutic benefits observed in smaller clinical studies are replicated, administration of these medications should produce several benefits, including: a reduction in time to pain free recovery and hence a more rapid return to employment; decreased requirements for narcotic analgesia; less need for urological out-patient clinic follow-up; decreased need for surgical intervention or lithotripsy; and substantial cost savings. If this therapy is beneficial, it will represent a major advance in the treatment of urolithiasis. This objective is a major stated goal of the NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) Clinical Urology Program, which has a stated mission to improve the treatment of urolithiasis. Kidney stones are a major public health issue, and one person in eight will be affected by the disease. If the hypothesis is verified, the researchers will provide the first medical therapy ever for this disease. This therapy, if effective, will reduce the amount of time a patient is off work because of the pain from the disease, and may also reduce the need for expensive and time-consuming surgical treatments.

The primary objective of this study is to compare the time to acceptable stone fragmentation during clinical use of the holmium laser when using energy settings 0.2J vs 0.8J. The hypothesis is that holmium laser energy settings 0.8J will require less time than lower energy settings 0.2J for fragmenting urinary stones. The clinical practice is to treat urinary stones until the stone is reduced to fragments ≤ 2 mm in size. This is determined by using the laser fiber which is 273 microns to visually estimate the size of the resultant fragments as described by Patel et al, J Endo 2014. Investigators will standardize the effect of stone size by creating a ratio of stone size to treatment time. In this study, the frequency is set at 15Hz. Thus, the study contains two arms: 0.2J&15Hz, and 0.8J&15Hz. Patients will be randomized into the two groups by the ratio of 1:1.

Urolithiasis is a frequent pathology, for which flexible ureteroscopy with endocorporeal laser lithotripsy has become the most frequently used surgical treatment. This procedure is limited to 90 minutes and will depend mainly on the total lithiasis volume. Knowing the duration of lithotripsy before the operation would allow to foresee situations of iterative procedures and to improve the patient's path (ambulatory or conventional surgery, work stoppage, optimization of operating times and operating room occupation times). "Kidney Stone Calculator" is a free tool capable of providing a calculi volumetry and predicting the duration of endocorporeal laser lithotripsy. The main objective of this study would be to evaluate the performance of the Kidney Stone Calculator in estimating the duration of laser lithotripsy during flexible ureteroscopy for renal calculi, by analyzing the agreement between the estimated and actual lithotripsy durations, evaluated by an intraclass correlation coefficient and its 95% confidence interval Eligible patients will be those scheduled for flexible ureteroscopy for renal calculi described on a non-injected abdominopelvic scan. A total of 240 patients over a 15-month inclusion period is planned, with a follow-up time of 3 months.

The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.

The objectives of the study are to assess the systemic exposure, safety and efficacy of three concentrations of OMS201 in subjects undergoing retrograde ureteroscopic removal of upper urinary tract stones.

The purpose of this study is to determine whether Renalof administration promotes partial or total dissolution of urinary calculi and improves physicochemical parameters and metabolic activity in patients with recurrent calcic urolithiasis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters will be assessed every 4 weeks.

Kidney stones are very common, and can inflict a significant degree of pain and renal damage. Some stones become obstructed in the ureter, the tube that drains the kidney. In order to remove these stones, an Urologist and their team use fluoroscopic guidance to do so, this involves continuous X-ray. Flouroscopy delivers a significant dose of radiation to the patient, as well as the health care team, which has been shown to have serious health consequences. Previous studies have shown that in certain populations, like pregnant women, stones can be managed using ultrasound guidance. The investigators propose that mid and distal ureteral stones could be managed using ultrasound guidance in conjunction with conventional stone removal techniques (ureteroscopy, lithotripsy, and ureteral stent placement), in lieu of fluoroscopy, thereby minimizing radiation to healthcare staff and patients. The investigators hypothesize that distal ureteral stones can be identified and efficiently fragmented and removed under ultrasound guidance in a safe and effective manner without the use of radiation.

This study is a non randomized non comparative study with two Siddha formulations Sindhuvallathy Mezhugu and Kalladaippu Kudineer are available in Siddha classical texts existing for longer period. But there is no scientific data is documented about these formulations. This study aimed to evaluate the efficacy of the study drugs for urolithiasis. After the preliminary drug standardization the clinical study is Started at The National Institute of Siddha Tambaram. The primary outcome measure is either the Expulsion of stones or Changes in the number and size of the stones with 45 days drug treatment.

The investigators have developed an extremely low dose renal computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of a single view abdominal radiograph. The investigators plan to test this exam in patients with known or suspected urolithiasis undergoing clinically indicated CT.

Following informed consent, all recruited patients will have a baseline non-contrast CT scan performed at the radiology department of "G. Gennimatas" hospital and reported by the same dedicated uroradiologist for evaluation of stone volume, location, and consistency. All patients will also have a free flow mid-stream urinalysis and culture before randomization. The level of pain related to stones will be evaluated in all patients with the VAS tool completed before commencement of treatment and at the end of the study. Patients with a DJ stent at study entry will also complete the mini-Ureteral Stent Symptoms Questionnaire (m-USSQ) and the PUF questionnaire completed one week into study, before commencement of treatment and at the end of the study after taking either RENALOF® or placebo. Patients with a DJ stent in situ at study entry, will have both ends of the DJ cut and send for culture during scheduled DJ stent change. Approximately 90 days after recruitment, all patients will have a follow up CT scan, done at "G. Gennimatas" hospital radiology department and evaluated by the same dedicated uroradiologist , and a mid-stream urinalysis and culture. Patients with a DJ in situ will have their catheters changed and cut ends from the distal and proximal stent coils of the removed DJ stents will be send for culture and sensitivity analysis. All patients will complete the VAS and the cohort of patients with DJ stents will complete both the mini-USSQ and PUF questionnaires. During the study period patients will be instructed to report to the research team any cases of upper or lower urinary tract infection documented with a positive urine culture and any treatment related adverse events.