[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07220980":3,"trial-entities:NCT07220980":109,"trial-summary:NCT07220980":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":14,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":38,"secondary_outcomes":45,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":68,"locations":71,"central_contacts":105,"overall_officials":106,"references":107,"see_also_links":108},"NCT07220980","171398","Optimal Duration of Foley Catheter After Bulbar Urethroplasty","Optimal Duration of Indwelling Urethral Foley Catheter Following Bulbar Urethroplasty: A Pragmatic Multi-Institutional Randomized Controlled Non-Inferiority Trial","ENROLLING_BY_INVITATION","2027-09","2025-12","2026-02-27","2024-08-28","Jane Kurtzman","OTHER",null,"The goal of this clinical trial is to learn when is the best time to remove a Foley catheter (tube used to drain urine from the bladder) after surgery in adult men who have a specific type of urethral stricture disease (narrowing of the tube that carries urine from the body). The main question it aims to answer is:\n\n\\- Is there a difference between removing the catheter at 7-10 days versus 18-21 days?\n\nResearchers will compare Foley removal at 7-10 days to removal at 18-21 days to see if there is a difference in problems after surgery or if the narrowing returns.\n\nParticipants will:\n\n* Complete a survey before surgery, when the catheter is removed, and within 12 months after surgery\n* Complete follow-up visits after surgery based on your specific medical needs and standard of care",[18],"Urethral Stricture, Bulbar",[],"INTERVENTIONAL",[22],"NA",{"count":24,"type":25},320,"ESTIMATED",[27,33],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DEVICE","Early catheter removal","Removal after 7-10 days",[32],"Early Removal",{"type":28,"name":34,"description":35,"armGroupLabels":36},"Later catheter removal","Removal after 18-21 days",[37],"Later Removal",[39,42],{"measure":40,"timeFrame":41},"Number of Participants who Experience a Stricture Recurrence","1 year",{"measure":43,"timeFrame":44},"Number of Participants who Experience a Perioperative Complication","From Foley insertion to Foley removal",[46],{"measure":47,"timeFrame":48},"Rate of Retrograde Urethrograms Performed on Day of Foley Removal","Foley Removal","MALE","18 Years","70 Years",false,{"inclusion":54,"exclusion":61,"raw_text":67},[55,56,57,58,59,60],"Cis-male patients","Age 18-70, inclusive","Bulbar urethral stricture undergoing a urethroplasty","Urethral stricture defect less than or equal to 7cm in length","First time urethroplasty","Negative urine analysis or urine culture",[62,63,64,65,66],"History of pelvic radiation","Diabetes with Hba1c greater than 8%","Penile urethral stricture","Posterior urethroplasty","Bulbar stricture greater than 7cm","Inclusion Criteria:\n\n* Cis-male patients\n* Age 18-70, inclusive\n* Bulbar urethral stricture undergoing a urethroplasty\n* Urethral stricture defect less than or equal to 7cm in length\n* First time urethroplasty\n* Negative urine analysis or urine culture\n\nExclusion Criteria:\n\n* History of pelvic radiation\n* Diabetes with Hba1c greater than 8%\n* Penile urethral stricture\n* Posterior urethroplasty\n* Bulbar stricture greater than 7cm",[69,70],"ADULT","OLDER_ADULT",[72,81,89,97],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Lahey Hospital & Medical Center","Burlington","Massachusetts","01805","United States",{"lat":79,"lon":80},42.50482,-71.19561,{"facility":82,"city":83,"state":84,"zip":85,"country":77,"geoPoint":86},"Western New York Urology Associates","Buffalo","New York","14203",{"lat":87,"lon":88},42.88645,-78.87837,{"facility":90,"city":91,"state":92,"zip":93,"country":77,"geoPoint":94},"Ohio State University","Columbus","Ohio","43212",{"lat":95,"lon":96},39.96118,-82.99879,{"facility":98,"city":99,"state":100,"zip":101,"country":77,"geoPoint":102},"University of Utah Hospital","Salt Lake City","Utah","84132",{"lat":103,"lon":104},40.76078,-111.89105,[],[],[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Bulbar urethral stricture",[],{"nct_id":4,"found":52,"summary":15,"prompt_version":15}]