[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"onabotulinumtoxin-a\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:onabotulinumtoxin-a":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100420437","antibiotic-usage-prior-to-onabotulinumtoxina-injection-100420437",false,"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.",true,"ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Antibiotic Stewardship","Overactive Bladder","Onabotulinumtoxin A","UTI","RECRUITING","2024-05-23",{"date":34,"type":35},"2024-05-24","ACTUAL",{"date":37,"type":35},"2021-03-23",{"date":39,"type":21},"2026-12",{"name":41,"class":42},"Benaroya Research Institute","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100515863","early-phase-1-safety-and-efficacy-of-botulinum-toxin-a-for-treatment-of-overactive-bladder-in-parkinsons-disease-100515863","NCT05997043","Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease","Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease:Randomized Controlled Trial","Inclusion Criteria:\n\n1. patients with idiopathic Parkinson's disease were diagnosed by experienced neurologists based on the diagnostic criteria of the International Motor Disorder Association.\n2. PD patients with overactive bladder were observed by voiding diary for 3 days and evaluated by OABSS score.\n3. Eligible males and females, aged between 25 and 80.\n4. The patient was treated with dopaminergic drugs, and if there was an wearing-off phenomenon, it was evaluated during the turning-off period or without taking the drug (when the patient developed one of the symptoms in WOQ-19 \\[13\\] and the symptom improved after the next medication, it suggested that there was an end-of-dose phenomenon).\n5. With a history of NDO ≥ 3 months, the symptoms of bladder overactivity were not fully controlled by anticholinergic drugs, which was defined as insufficient response after 4 weeks of treatment or unbearable side effects after 2 weeks of optimized dose treatment.\n6. patients who took anticholinergic drugs at baseline must maintain a stable dose throughout the study, while those who did not take anticholinergic drugs could not take them during the study period.\n7. if necessary, the patient must be willing to initiate intermittent catheterization (CIC).\n8. the informed consent of the subject or his guardian has been obtained, and the informed consent of the clinical trial has been signed voluntarily.\n\nExclusion Criteria:\n\n1\\) Ultrasonography showed that the residual urine of bladder was larger than 10ml. 2) Patients with glaucoma and myasthenia gravis are not suitable for botulinum toxin.\n\n3\\) Indwelling catheter or intermittent catheterization (CIC) is needed to empty the bladder.\n\n4\\) Patients have been treated with botulinum toxin for any urinary disease. 5) People who are known to be allergic or allergic to drugs and their ingredients 6) Take drugs that interfere with neuromuscular transmission. 7) Receiving anticoagulant therapy. 8) There is infection at the injection site. 9)With dementia, Parkinson's dementia scale ≤ 73.5 at screening time \\[15\\] or with Parkinson's disease psychiatric disorder","25 Years","80 Years",{"count":54,"type":21},60,[56],"EARLY_PHASE1","A randomized controlled trial is to be conducted to confirm the efficacy and safety of intramuscular injection of botulinum toxin in the treatment of Parkinson's bladder overactivity.",[59,28,29],"Parkinson's Disease","2023-08-16",{"date":62,"type":35},"2023-08-18",{"date":64,"type":21},"2023-08-26",{"date":66,"type":21},"2026-07-01",{"name":68,"class":42},"Zhujiang Hospital"]