Plain-English translation of NCT04527445 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
Sacral neuromodulation is a device-based treatment for overactive bladder that involves implanting a small lead near the sacral nerve during surgery. This trial is testing whether the surgeon can use special lower-radiation settings on the imaging equipment (fluoroscopy) during lead placement without affecting the quality or safety of the procedure. The goal is to reduce the amount of radiation exposure patients receive during this surgery.
Fluoroscopy imaging is necessary to guide surgeons during lead placement, but it exposes patients to radiation. This trial exists to find out whether reducing the radiation dose through different equipment settings can keep the procedure just as safe and effective while protecting patients from unnecessary radiation exposure.
You likely qualify if…
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You will undergo sacral neuromodulation lead implantation surgery as you normally would. The only difference is that you will be randomly assigned to either have your surgery guided by lower-radiation fluoroscopy settings or standard fluoroscopy settings. The surgeon will monitor the lead placement carefully and can switch to standard settings if needed to ensure safe placement. Your participation involves the surgery itself and standard follow-up care after the procedure.
AI-generated summary from trial data · Sep 24, 2026 · Not medical advice
United States
Sponsor
Loma Linda University
Enrollment target
~44 participants
Started
June 2026
Primary completion
June 2027
Age range
18 Years – 89 Years
Last updated on clinicaltrials.gov in March 2026.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Forrest Jellison, MD
Loma Linda University
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.