Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
Renal CalculiUrinary CalculiThis is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. The procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else. Safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (CT) images before and after the procedure.
Effect of Furosemide on ESWL Outcomes for Renal and Ureteral Calculi
UrolithiasisNephrolithiasis2 moreThe minimally-invasive extracorporeal shockwave lithotripsy (ESWL) procedure is generally considered the best first-line treatment option for most adults and children with nephrolithiasis, especially when the calculi are smaller than 2 cm in size. Despite some promising results, few clinical trials have assessed the impact of furosemide on the outcome of ESWL. This study seeks to determine the effect of furosemide on ESWL outcomes when treating renal and ureteral calculi, hypothesizing that it will result in better outcomes for patients. The present double-blind, randomized clinical trial includes 500 adults aged 18-60 years referring to the ESWL Clinic of Shahid Faghihi Hospital. Using block randomization, the patients are randomly assigned to one of two groups. All patients are to receive sedation with intravenous midazolam and 1000 ml of normal saline 30 minutes before ESWL. The only difference between the groups is that in the furosemide group, 40 mg of furosemide is added to the normal saline in the drug preparation room before administration. All patients are kept under heart monitoring and pulse oximetry until recovery. Pain will be checked for all participants via a telephone interview 24 hours later. The outcomes and possible side effects of ESWL will be evaluated for all patients after two and twelve weeks.
SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)
Kidney StoneUrolithiasis5 moreThe goal of this clinical trial is to test the Break Wave™ system in patients with upper urinary tract stones. The main question it aims to answer is whether the device is safe and effective in fragmenting (breaking) stones. Participants will a) undergo the Break Wave™ procedure, b) have a telehealth visit at 2 weeks, and c) return for an imaging study at approximately 10 weeks post-procedure.
Clinical Outcomes and Healthcare Economics of SOLTIVE Compared to Ho:YAG Laser in Urolithiasis
Kidney StoneTo compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium laser compared to Ho:YAG laser for the treatment of urolithiasis. The hypothesis is that utilizing the SOLTIVE Thulium laser for the treatment of urolithiasis will result in a more efficient procedure, with comparable stone free rate to that of Holmium laser and subjective improvement in physician satisfaction.
SP TLF Versus Ho:YAG Laser
Urinary CalculiThe investigators aim to compare the performance of the Super Pulse Thulium fiber laser (SP TFL) with that of the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser. The investigators hypothesize that the electronically-modulated laser diodes, of the TFL offers the most comprehensive and flexible range of laser parameters among laser lithotripters leading to more efficient (4 times more) and effective stone dusting resulting in production of finer dust particles obviating the need for postoperative ureteric stenting which remains a major source of patient discomfort.
The Use of Direct Puncture Technique With Mini-PCNL
UrolithiasisA single-center randomized study to evaluate the safety and effectiveness of direct puncture of the caliceal system in mini-percutaneous nephrolithotripsy. 60 patients Inclusion criteria: all patients aged 18 to 70 years who are planning mini-PCNL, ready to consent to the study ASA scale 1-3 Solitary stone up to 2.5 cm Single access to the caliceal system Exclusion criteria: Active infectious process Coagulopathies Abnormalities of the urinary system
Comparison and Evaluation of USSQ, OABSS, and the Drainage/Anti-reflux Effect Between Three Kinds...
UrolithiasisOveractive Bladder SyndromeIndwelling double-J ureteral stent (D-J stent) are routinely placed in patients who received ureteroscopic lithotripsy (URL) in Xinhua Hospital Urology Department. At present, three types of D-J stents, namely Cook/Kang Yi Bo(KYB)/Urovisionare are used, and usually removed in the day ward four weeks after surgery. This study intends to randomly divide patients with urolithiasis based on the preoperative OABSS (overactive bladder symptom score) questionnaire into three groups, namely Cook D-J stent group, KYB anti-reflux D-J stent group, Urovision trigonal D-J stent group, with corresponding D-J stent indwelled for 4 weeks respectively. The patient's USSQ ureteral stent symptom questionnaire)scale and OABSS scale were collected at 1 week, 4 weeks (before the removal of D-J stents), and 5 weeks (1 week after removal of D-J stents) after URL operation, and the D-J stents removed from the patients were collected, and their drainage and anti-reflux effects were measured in vitro.
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
Kidney CalculiKidney Diseases4 moreStone disease is a common condition, affecting approximately 9% of Americans in 2007. It causes great morbidity and is also a costly condition, estimated to cost the US healthcare system approximately 3.79 billion dollars in 2007. Ureteroscopy (URS) is the most commonly performed surgical treatment for upper tract stone disease. Ureteral stenting is a common practice after ureteroscopy and placed in ~75% of cases to prevent ureteral edema and renal obstruction. Unfortunately, ureteral stenting can be very painful and has been shown to increase the rate of emergency room visits. Many strategies have been attempted to decrease pain with ureteral stenting including modification of stent material and designs, but efforts so far have been unsuccessful in decreasing stent-related morbidity. Stent-related morbidity is hypothesized to be secondary to irritation of ureteral/bladder mucosa and muscle. Analgesics such as alpha blockers and NSAIDs have been shown to reduce stent morbidity. Anticholinergic drugs are also utilized as they decrease bladder spasms and, therefore, are hypothesized to reduce stent irritation. However, the evidence for anticholinergics has been conflicting. Anticholinergics also have a serious side effect profile including dry mouth, dry eyes, constipation, urinary retention, blurred vision, and even dementia. Some authors even hypothesize that these side effects may offset any purported benefits the anticholinergics provide for stent-morbidity. Methocarbamol is anti-spasmodic muscle relaxant that is believed to work by acting on central neurons and possibly by blocking sodium channels. Given that anticholinergics have many side effects and questionable efficacy, the investigators hypothesize that methocarbamol may achieve superior analgesia for stent morbidity and stent-related bladder spasms. Oxybutynin is used for the treatment of overactive bladder. The rationale is that the oxybutynin relaxes the muscles in the bladder to help decrease problems of urgency and frequent urination caused by the urinary stent irritation. Since anticholinergics have multiple side effects, finding an equally efficacious alternative with less side effects is highly desirable. This study will evaluate the clinical and demographic factors of patients undergoing ureteroscopy and treated postoperatively with methocarbamol vs. oxybutynin for stent-related morbidity. Additionally, the study will aim to understand the postoperative outcomes and complication rates of patients discharged with methocarbamol vs. oxybutynin after ureteroscopy with a ureteral stent in place.
Treatment of Upper Urinary Tract Stones With a Diameter≤2cm by Intelligent Pressure-controlled Flexible...
Urinary CalculiThe aim of this trial is to compare the efficacy and safety of flexible ureteroscope with intelligent control of renal pelvic pressure (FURL-ICP) and traditional flexible ureteroscope(f-URL) in the treatment of upper urinary stones ≤ 2cm in diameter. It is designed as a multicenter, parallel randomized controlled trial with two arms. At least 449 patients with upper urinary stones ≤ 2cm in diameter will be invited to participant in this study. Patients will be assigned to intervention group (FURL-ICP group) or control group (f-URL) by a simple random sampling technique with a rate of 1:1. The baseline of participants include demographic data, urine analysis, blood cell analysis, blood biochemical analysis, and urinary computer tomography (CT) with a slice thickness of 2mm. The primary outcomes are postoperative stone-free rate (SFR) of one month by CT scan and postoperative fever rate (body temperature > 38.5 ℃ within 3 days after operation). Secondary outcomes include operating time, degree of ureteral injury, SFR of one day.
Shuotongo Ureteroscopy for Upper Urinary Tract Stones
Urinary CalculiUreteroceleThe purpose of this study is to use the Shuotong ureteroscopy for surgical treatment of patients with upper urinary tract stones, taking advantage of the fact that the Shuotong mirror can be used for simultaneous lithotripsy and stone removal, thus maximizing the discharge of stones from the body and improving the stone removal rate.