Actively Recruiting
Reduction in Fluoroscopy Radiation Exposure During Lead Implantation for Sacral Neuromodulation: A Randomized Prospective Study
Led by Loma Linda University · Updated on 2026-03-06
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare radiation exposure during lead placement in sacral neuromodulation procedures for patients with overactive bladder. It evaluates conventional fluoroscopy settings against an experimental reduced radiation technique to understand differences in radiation exposure and related outcomes. The study is randomized and conducted in an operating room setting with patients scheduled for lead implantation. Participants will be randomly assigned to one of two groups: the experimental group receiving reduced radiation fluoroscopy, where the C-arm is set at 1 pulse per second with reduced current, or the control group receiving conventional fluoroscopy at 30 pulses per second with default current. The surgeon may adjust settings during the procedure for optimal lead placement and safety, with any changes recorded. During the study, researchers will measure radiation exposure, optimal lead placement, operative complications, and operative times at the time of surgery. Additionally, participants will complete bladder voiding logs and clinical questionnaires three months after surgery to assess outcomes. The study begins in June 2026 and continues until June 2027, with no masking or blinding applied.
CONDITIONS
Brief Title
Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing lead implantation for sacral neuromodulation
- Diagnosis of overactive bladder characterized by urinary urgency, frequency, nocturia, with or without urgency incontinence
- Age between 18 and 89 years
- Able to provide consent and undergo surgery
You will not qualify if you...
- Diagnosis of neurogenic bladder
- Body mass index greater than 40
- Presence of peripheral neuropathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo lead implantation surgery with fluoroscopy using either reduced radiation settings or conventional settings during the procedure.
1 surgical visit (in-person)
Duration - 3 months
Participants are monitored for clinical outcomes, voiding function, and any complications after surgery.
Approximately 2 follow-up visits over 3 months
Trial Site Locations
Total: 1 location
1
Loma Linda University Health
Loma Linda, California, United States, 92354
Actively Recruiting
Research Team
F
Forrest Jellison, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here