[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Benaroya Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":127},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,75,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":25,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100622000","intradetrusor-onabotulinumtoxin-a-botox-at-the-time-of-transurethral-resection-of-the-prostate-or-transurethral-waterjet-ablation-of-the-prostate-for-mixed-lower-urinary-tract-symptoms-100622000",false,"NCT07377929","Intradetrusor Onabotulinumtoxin A (Botox) at the Time of Transurethral Resection of the Prostate or Transurethral Waterjet Ablation of the Prostate for Mixed Lower Urinary Tract Symptoms","Inclusion Criteria:\n\n1. Male \\>= 18 years of age and being scheduled to undergo TURP or Aquablation and Botox procedure.\n2. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\n   Exclusion Criteria:\n3. Non-English speaking\n4. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n5. History of receiving Botox in the bladder, within the previous 12 months.","MALE","18 Years",{"count":18,"type":19},20,"ESTIMATED","OBSERVATIONAL","Patients with longstanding obstructive lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH) can also develop symptoms of overactive bladder syndrome (OAB). Transurethral resection of the prostate (TURP) and Transurethral Waterjet Ablation of the Prostate (Aquablation) are amongst the gold standard surgical treatments for BPH. However, in the immediate post-operative period, TURP and Aquablation can also include OAB-like symptoms, including urinary frequency and urgency. For men with baseline OAB symptoms, this initial worsening of symptoms can be distressing.\n\nBotox is an FDA approved medication with on-label indications to treat overactive bladder.\n\nThe purpose of this study is to evaluate the outcomes of men who have Botox concurrent with their TURP or Aquablation.",[23,24],"Benign Prostatic Hypertrophy (BPH)","Lower Urinary Track Symptoms",[26,27,28,29,30,31],"lower urinary tract symptoms (LUTS)","benign prostatic hypertrophy (BPH)","overactive bladder syndrome (OAB)","Transurethral resection of the prostate (TURP)","Transurethral Waterjet Ablation of the Prostate (Aquablation)","Botox","RECRUITING","2026-01-22",{"date":35,"type":36},"2026-01-30","ACTUAL",{"date":38,"type":19},"2026-01-19",{"date":40,"type":19},"2027-05-01",{"name":42,"class":43},"Benaroya Research Institute","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":16,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":44},"100561083","phase-3-a-pilot-study-to-evaluate-barhemsys-for-the-prevention-of-postoperative-nausea-and-vomiting-in-the-bariatric-surgery-population-100561083","NCT06585540","A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea And Vomiting in the Bariatric Surgery Population","Inclusion Criteria:\n\n* The study will recruit adult patients (Age 18-65) scheduled for bariatric surgery. Additional inclusion criteria include ASA class I-III and patients who plan to be inpatient for at least 24 hours.\n\nIncluded Surgeries:\n\nRobotic, Laparoscopic or Open Roux-en-Y Robotic, Laparoscopic or Open Gastric Sleeve Robotic, Laparoscopic or Open Gastrectomy Robotic, Laparoscopic or Open Revision Gastric Bypass\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n* Congenital QTc abnormalities\n* Current use of droperidol\n* Parkinson's disease\n* Allergy to Barhemsys\n* GFR \\< 30 mL\u002Fmin\u002F1.73m2\n* Emergency surgery or add-on cases",true,"ALL","65 Years",{"count":55,"type":19},100,"INTERVENTIONAL",[58],"PHASE3","To assess the effectiveness of Amisulpride to treat Post Operative Nausea and Vomiting (PONV) and to assess the effectiveness of Amisulpride to prevent PONV following bariatric surgery.",[61],"Post Operative Nausea and Vomiting",[61,63,64,65,66],"Bariatric Surgery","Bariatric","Barhemsys","Amisulpride","2024-09-24",{"date":69,"type":36},"2024-09-26",{"date":71,"type":36},"2024-09-13",{"date":73,"type":19},"2026-01",{"name":42,"class":43},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":51,"sex":52,"minAge":16,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":56,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":44},"100420437","antibiotic-usage-prior-to-onabotulinumtoxina-injection-100420437","NCT04754737","Antibiotic Usage Prior to OnabotulinumtoxinA Injection","Optimizing Antibiotic Use in Treatment of Overactive Bladder: Evaluating the Need for Prophylactic Antibiotics Prior to OnabotulinumtoxinA Injection in Patients Without Urinary Tract Infection","Inclusion Criteria:\n\n* Age ≥ 18\n* Diagnosis of OAB who have failed 1st and 2nd line therapies per the AUA\u002FSUFU OAB guidelines (including bladder training, dietary modification and pharmacotherapy with an anticholinergic and\u002For beta-3 agonist)\n* Not symptomatic for UTI at the time of injection\n* Negative urinalysis at the time of the injection defined as: negative for nitrites and leukocyte esterace, with urine white blood cell count less than 5 per high-power field\n* Consent to participate in the study.\n\nExclusion Criteria:\n\n* Antibiotic usage within 48 hours prior to intradetrusor onabotulinumtoxinA injection\n* Women who are pregnant or planning to become pregnant, women who are breastfeeding\n* Concurrent use of onabotulinumtoxinA injection with maximum cumulative dose exceeding 400 units in a 3-month interval.",{"count":83,"type":19},200,[85],"NA","Intradetrusor injection of onabotulinumtoxinA, which is performed through a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for overactive bladder. Intradetrusor of onabotulinumtoxinA is currently standard of care of patients with OAB who have persistent OAB symptoms despite behavioral therapies and oral medication treatments for OAB. As one of the main adverse events associated with intradetrusor injection of onabotulinumtoxinA is UTI, and published guidelines for cystoscopic procedures with manipulation recommend the use of prophylactic antibiotics, a single dose of prophylactic antibiotic is administered prior to this procedure. However, these recommendations are primarily based on data from randomized controlled trials (RCTs) involving antimicrobial prophylaxis during transurethral resection of the prostate. A previously published prospective study demonstrated that the rate of post-procedural UTI did not differ amongst patients with neurogenic bladder who did not receive prophylactic antibiotics and were asymptomatic for UTI, regardless of whether they had sterile urine cultures or asymptomatic bacteriuria, suggesting that patients who are not symptomatic for UTI may not require antibiotic prophylaxis prior to intradetrusor onabotulinumtoxinA injection. Studies have reported that up to 50% of antibiotic usage is inappropriate, leading to unnecessary exposure of patients to potential complications of antibiotic therapy, including Clostridium difficile infection which can cause recurrent diarrhea that may progress to sepsis and death, increasing antibiotic resistances, as well as dermal\u002Fallergic and gastro-intestinal manifestations. Therefore, in an effort to optimize antibiotic use, the investigators propose a prospective, randomized study to formally evaluate the differences in UTI frequency in subjects who have a negative urinalysis and are not symptomatic for UTI and receive prophylactic antibiotics at the time of intradetrusor onabotulinumtoxinA injection compared to those who do not receive prophylactic antibiotics at the time of injection. The proposed study seeks to evaluate the current practice standard of antibiotic prophylaxis prior to intradetrusor onabotulinumtoxin injection.",[88,89,90,91],"Antibiotic Stewardship","Overactive Bladder","Onabotulinumtoxin A","UTI","2024-05-23",{"date":94,"type":36},"2024-05-24",{"date":96,"type":36},"2021-03-23",{"date":98,"type":19},"2026-12",{"name":42,"class":43},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":51,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":56,"phases":108,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":44},"100370378","phase-4-optimizing-pain-control-in-transurethral-resection-of-the-prostate-100370378","NCT04102566","Optimizing Pain Control in Transurethral Resection of the Prostate","Inclusion Criteria:\n\n* Are identified as candidates for TURP\n* Are 18 years of age or greater\n* Are proficient in English\n\nExclusion Criteria:\n\n* Have filled an opioid prescription in the last 2 months\n* Have an allergy to a medication included in the protocol\n* Have a history of pelvic radiation\n* Have renal failure (Serum Cr \\> 2.0 mg\u002Fdl), peptic ulcer disease, history of gastric bypass, cirrhosis, or other contraindication precluding use of NSAID's\n* Have liver failure, hepatitis, or alcohol abuse which precludes use of acetaminophen",{"count":107,"type":19},50,[109],"PHASE4","The purpose of this study is to develop a multi-modal protocol for pain management after TURP that minimizes opioid use. The investigators hypothesize this approach will provide non-inferior pain control to the current standard of care which includes opioids as the primary agent. The investigators believe this is an important step in reducing the opioid epidemic in surgical patients.",[112,113,114],"Pain","BPH With Urinary Obstruction","BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms",[116,117,118],"postoperative pain","Transurethral resection of the prostate","Multimodal pain control","2019-09-25",{"date":121,"type":36},"2019-09-27",{"date":123,"type":36},"2017-12-08",{"date":125,"type":19},"2019-12-01",{"name":42,"class":43},""]