[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07044726":3,"trial-entities:NCT07044726":104,"trial-summary:NCT07044726":108},{"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":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":46,"sex":51,"minimum_age":52,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":66,"locations":69,"central_contacts":95,"overall_officials":100,"references":102,"see_also_links":103},"NCT07044726","25.0260","Betadine vs Sterile Water for Periurethral Preparation","Betadine vs Sterile Water for Periurethral Preparation Prior to Straight Catherization in the Clinic Setting: A Randomized Controlled Trial","RECRUITING","2028-05-21","2026-05","2026-05-04","2025-06-30","University of Louisville","OTHER",true,"The purpose of this study is to determine whether cleaning of the urethra, or external opening to the bladder, with sterile water (water that has been treated to remove bacteria and living organisms) vs Betadine also known as Povidone-Iodine (a medical grade cleaning solution) changes the rates of bacteria in the urine after a temporary catheter, or draining tube, is placed into the bladder. Chemical antiseptics, including Betadine, are the current standard of care. An additional goal of this study is to determine whether cleaning of the urethra, or external opening to the bladder, with sterile water vs betadine changes the amount of discomfort or pain patients experience with placement of a temporary catheter, or draining tube, in the bladder.",null,[19,20],"Catherization","Urinary Tract Infection Bacterial",[22,23,19],"Betadine","Sterile Water","INTERVENTIONAL","PREVENTION",[27],"PHASE4",{"count":29,"type":30},148,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Povidone-Iodine","Providone-Iodine for periurethral preparation",[22],{"type":33,"name":38,"description":39,"armGroupLabels":40},"Sterile water","Sterile water for periurethral preparation",[23],[42],{"measure":43,"description":44,"timeFrame":45},"Bacteruria","Bacteruria defined as the presence of bacteria within patient urine evaluated with urinalysis. Bacterial presence will be further characterized by colony forming unit count on urine culture.","Within 2 weeks of the patients procedure date",[47],{"measure":48,"description":49,"timeFrame":50},"Urethral Pain","Urethral pain at the time of catheterization rated by patients on a visual analog scale zero to ten with zero representing no pain and ten representing the worst pain of their life.","At the time of catherization","FEMALE","18 Years",{"inclusion":54,"exclusion":57,"raw_text":65},[55,56],"Aged 18+","Patient undergoing in office straight catherization",[58,59,60,61,62,63,64],"History of culture proven recurrent urinary tract infection (2 in any 6-month period or 3 in any 12-month period)","Urine Analysis with +Nitrites","Catherization for any reason in the last 4 weeks","History of Iodine allergy","Patients unable to speak English","Patient does not have the capacity to consent","2-3rd trimester pregnancy","Inclusion Criteria:\n\n* Aged 18+\n* Patient undergoing in office straight catherization\n\nExclusion Criteria:\n\n* History of culture proven recurrent urinary tract infection (2 in any 6-month period or 3 in any 12-month period)\n* Urine Analysis with +Nitrites\n* Catherization for any reason in the last 4 weeks\n* History of Iodine allergy\n* Patients unable to speak English\n* Patient does not have the capacity to consent\n* 2-3rd trimester pregnancy",[67,68],"ADULT","OLDER_ADULT",[70,88],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":85},"UofL Physicians - Urogynecology Springs Urogynecology Office","Louisville","Kentucky","40205","United States",[77,82],{"name":78,"role":79,"phone":80,"email":81},"Kathryn Seymour, MD","CONTACT","502-588-7660","kathryn.seymour@louisville.edu",{"name":83,"role":84},"Ankita Gupta, MD","PRINCIPAL_INVESTIGATOR",{"lat":86,"lon":87},38.25424,-85.75941,{"facility":89,"status":8,"city":72,"state":73,"zip":90,"country":75,"contacts":91,"geoPoint":94},"UofL Health - Urogynecology Mary & Elizabeth Hospital, Medical Plaza 3","40215",[92,93],{"name":78,"role":79,"phone":80,"email":81},{"name":83,"role":84},{"lat":86,"lon":87},[96,98],{"name":97,"role":79,"phone":80,"email":81},"Kathryn C Seymour, MD",{"name":99,"role":79,"phone":80},"Ankita Gupta, MD, MPH",[101],{"name":99,"affiliation":13,"role":84},[],[],{"nct_id":4,"conditions":105,"biomarkers":107},[106],"Urinary Tract Infection",[],{"nct_id":4,"found":15,"summary":109,"prompt_version":119},{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an interventional study planning to enroll 148 participants. It compares two different cleaning methods: Povidone-Iodine (Betadine) and sterile water.","completed","Betadine vs. Sterile Water for Catheter Preparation","This study is comparing two ways to clean the area around the urethra (the opening where urine leaves your body) before a temporary catheter (a tube to drain urine) is placed. Researchers want to see if cleaning with sterile water (water treated to remove germs) or Betadine (a medical cleaning solution) changes the amount of bacteria in your urine afterward. They also want to know if one method causes more discomfort or pain. You may be able to join if you are an adult woman, 18 or older, having a straight catheter placed in the office. The study will measure bacteria in your urine within two weeks of the procedure. The current status of this study is unclear.","Your urine will be checked for bacteria within two weeks after your catheter procedure.",118,"Not specified in the trial record.","Not stated in the trial record.",[38],"v2"]