[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04527445":3,"trial-entities:NCT04527445":100,"trial-summary:NCT04527445":103},{"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":23,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":48,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":15,"eligibility_criteria":67,"std_ages":73,"locations":76,"central_contacts":92,"overall_officials":95,"references":98,"see_also_links":99},"NCT04527445","5200182","Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement","Reduction in Fluoroscopy Radiation Exposure During Lead Implantation for Sacral Neuromodulation: A Randomized Prospective Study","RECRUITING","2027-06","2026-03","2026-03-06","2026-06","Loma Linda University","OTHER",false,"Fluoroscopy is performed when placing a lead during a sacral neuromodulation procedure. During lead placement, subjects will receive either conventional or experimental fluoroscopic settings. The radiation exposure will be compared between the two groups.","Patients scheduled for lead implantation during sacral neuromodulation in the operating room and consent will be included in this study. Placement of the lead in the operating room with fluoroscopy is the standard of care in this procedure. Fluoroscopy is performed with a C-arm and there are settings that change the radiation exposure. Patients scheduled to undergo lead placement will be randomized to: a) the investigational (reduced radiation with fluoroscopic settings) or b. the control (conventional fluoroscopy).\n\nThe surgeon can change fluoroscopy radiation exposure by changing C-arm settings from the reduced radiation to conventional fluoroscopic options. During the surgery, the surgeon may change the settings from reduced radiation (intervention) to conventional fluoroscopy (control) to safely place lead. The surgeon will use their judgment to optimally place lead and maintain safety during placement. Any deviation from randomization will be recorded.\n\nThe intervention arm is defined: Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.\n\nThe control arm is defined: The standard of care in the conventional fluoroscopy, the C-arm is set at 30 pulses-per-second and the current set at the default.",[19,20,21,22],"Radiation Exposure","Overactive Bladder","Urge Incontinence","Urgency-frequency Syndrome",[24,25],"Sacral Neuromodulation","Fluoroscopy","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},44,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"PROCEDURE","Reduced radiation fluoroscopy","See previous information about each arm",[39],"Reduced Radiation Fluoroscopy",{"type":35,"name":41,"description":37,"armGroupLabels":42},"Conventional fluoroscopy",[43],"Conventional Fluoroscopy",[45],{"measure":19,"description":46,"timeFrame":47},"measure radiation exposure, milligray (mGy)","At time of procedure",[49,52,56,58,61],{"measure":50,"description":51,"timeFrame":47},"Optimal lead placement","based on intraoperative motor response",{"measure":53,"description":54,"timeFrame":55},"Voiding log (Bladder Record)","Clinical Outcome","3 months after surgery",{"measure":57,"timeFrame":55},"Clinical Outcome assessed by validated questionnaire",{"measure":59,"description":60,"timeFrame":47},"Inoperative complications","surgery complication",{"measure":62,"description":63,"timeFrame":47},"Operative times","minutes","ALL","18 Years","89 Years",{"inclusion":68,"exclusion":70,"raw_text":72},[69],"Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.",[71],"neurogenic bladder, BMI \\>40, or peripheral neuropathy.","Inclusion Criteria:\n\n* Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.\n\nExclusion Criteria:\n\n* neurogenic bladder, BMI \\>40, or peripheral neuropathy.",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":78,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":89},"Loma Linda University Health","Loma Linda","California","92354","United States",[84],{"name":85,"role":86,"phone":87,"email":88},"Forrest Jellison, MD","CONTACT","909-558-8724","fjellison@llu.edu",{"lat":90,"lon":91},34.04835,-117.26115,[93],{"name":85,"role":86,"phone":94,"email":88},"909 558-2830",[96],{"name":85,"affiliation":13,"role":97},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":101,"biomarkers":102},[20],[],{"nct_id":4,"found":104,"summary":105,"prompt_version":114},true,{"design":106,"status":107,"heading":6,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an interventional study that will randomly assign participants to one of two groups: reduced radiation fluoroscopy or conventional fluoroscopy. It plans to enroll 44 participants.","completed","This study is looking at ways to reduce radiation exposure during a procedure called sacral neuromodulation lead placement. This procedure helps people with overactive bladder, which can cause urinary urgency, frequency, and incontinence. You would receive either reduced radiation fluoroscopy or conventional fluoroscopy during the lead placement. Fluoroscopy uses X-rays to help doctors see inside your body. The main goal is to compare the amount of radiation exposure between these two groups. The study plans to enroll 44 participants aged 18 to 89 who are having this procedure for overactive bladder. We don't know the current recruitment status.","Radiation exposure is measured at the time of the procedure, so there is no specified follow-up period after that.",98,"You would undergo a sacral neuromodulation lead implantation procedure, during which you would receive either reduced radiation or conventional fluoroscopy. The radiation exposure will be measured at the time of the procedure.","Not stated in the trial record.",[36,41],"v2"]