RecruitingNot ApplicableNCT04527445

Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

Reduction in Fluoroscopy Radiation Exposure During Lead Implantation for Sacral Neuromodulation: A Randomized Prospective Study


Sponsor

Loma Linda University

Enrollment

44 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether ultrasound guidance during sacral neuromodulation lead placement can reduce the amount of X-ray radiation patients are exposed to. Sacral neuromodulation is a procedure where a small device is implanted near the tailbone to send electrical signals to the bladder nerves, treating overactive bladder symptoms like urgency, frequency, and leakage. Traditionally this procedure uses a lot of fluoroscopy (real-time X-ray). Researchers want to see if ultrasound can achieve the same accuracy with less radiation. You may be eligible if: - You are between 18 and 89 years old - You are having a sacral neuromodulation lead implant for overactive bladder (urgency, frequency, nocturia, with or without incontinence) You may NOT be eligible if: - You have a neurogenic bladder (nerve-caused bladder dysfunction) - Your BMI is above 40 - You have peripheral neuropathy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREReduced radiation fluoroscopy

See previous information about each arm

PROCEDUREConventional fluoroscopy

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Locations(1)

Loma Linda University Health

Loma Linda, California, United States

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NCT04527445


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