Reducing radiation exposure during sacral neuromodulation lead placement
Reduction in Fluoroscopy Radiation Exposure During Lead Implantation for Sacral Neuromodulation: A Randomized Prospective Study
NA · Loma Linda University · NCT04527445
This study tests if using lower radiation settings during sacral neuromodulation lead placement can help keep patients with overactive bladder safe while still getting the procedure done correctly.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Loma Linda University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT04527445 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of reduced radiation fluoroscopy settings compared to conventional fluoroscopy during the lead placement for sacral neuromodulation in patients with overactive bladder. Patients scheduled for this procedure will be randomized into two groups: one receiving the experimental reduced radiation settings and the other receiving standard fluoroscopic settings. The primary focus is to compare the radiation exposure between these two groups while ensuring optimal lead placement by the surgeon. The study aims to enhance patient safety by minimizing radiation exposure during this common procedure.
Who should consider this trial
Good fit: Ideal candidates are patients with overactive bladder who are scheduled for lead implantation for sacral neuromodulation.
Not a fit: Patients with neurogenic bladder, a BMI over 40, or peripheral neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce radiation exposure for patients undergoing sacral neuromodulation, enhancing their safety during the procedure.
How similar studies have performed: While the approach of reducing radiation exposure in fluoroscopy is being explored, this specific application in sacral neuromodulation is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence. Exclusion Criteria: * neurogenic bladder, BMI \>40, or peripheral neuropathy.
Where this trial is running
Loma Linda, California
- Loma Linda University Health — Loma Linda, California, United States (RECRUITING)
Study contacts
- Principal investigator: Forrest Jellison, MD — Loma Linda University
- Study coordinator: Forrest Jellison, MD
- Email: fjellison@llu.edu
- Phone: 909 558-2830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Radiation Exposure, Overactive Bladder, Urge Incontinence, Urgency-frequency Syndrome, Sacral Neuromodulation, Fluoroscopy