Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorLoma Linda University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.
Disqualifiers
neurogenic bladder, BMI >40, or peripheral neuropathy.
Trial design
Design model
Parallel
Treatments tested in this trial
Reduced radiation fluoroscopy
Procedure/SurgerySee previous information about each arm
Conventional fluoroscopy
Procedure/SurgerySee previous information about each arm
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Reduced Radiation FluoroscopyExperimental treatment 1 intervention
Group B: Conventional FluoroscopyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Radiation Exposure
measure radiation exposure, milligray (mGy)
Time frame
At time of procedureSecondary outcomes
1
Optimal lead placement
based on intraoperative motor response
Time frame
At time of procedure2
Voiding log (Bladder Record)
Clinical Outcome
Time frame
3 months after surgery3
Clinical Outcome assessed by validated questionnaire
Time frame
3 months after surgery4
Inoperative complications
surgery complication
Time frame
At time of procedureSponsors and contacts
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Source ClinicalTrials.gov