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Search / Trial NCT04527445

Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

Launched by LOMA LINDA UNIVERSITY · Aug 25, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Sacral Neuromodulation Fluoroscopy

ClinConnect Summary

This clinical trial is studying ways to reduce radiation exposure during a specific procedure called sacral neuromodulation, which helps treat conditions like overactive bladder and urge incontinence. Participants will be divided into two groups: one will receive standard fluoroscopy settings, while the other will receive experimental settings designed to lower radiation during the procedure. The goal is to see how much radiation each group is exposed to, which can help improve safety for patients undergoing this treatment.

To be eligible for this trial, participants should be between the ages of 65 and 74 and must have issues with urinary urgency, frequency, and nighttime urination, with or without incontinence. However, individuals with certain conditions, like neurogenic bladder or a high body mass index (BMI over 40), cannot participate. If you join the trial, you can expect to receive the same treatment for your overactive bladder, but with a chance to help researchers understand how to make the procedure safer for everyone.

Gender

ALL

Eligibility 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.

About Loma Linda University

Loma Linda University is a prominent academic institution dedicated to advancing health and wellness through innovative research and education. As a sponsor of clinical trials, Loma Linda University leverages its extensive medical and scientific expertise to conduct rigorous studies aimed at improving patient outcomes and public health. With a commitment to ethical practices and patient safety, the university collaborates with a diverse network of healthcare professionals and researchers to explore novel therapeutic interventions and enhance clinical knowledge across various medical disciplines. Through its clinical trials, Loma Linda University seeks to contribute valuable insights to the medical community and foster advancements in healthcare delivery.

Locations

Loma Linda, California, United States

Patients applied

0 patients applied

Trial Officials

Forrest Jellison, MD

Principal Investigator

Loma Linda University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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