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Radiation

Reduced Radiation Fluoroscopy for Overactive Bladder

N/A
Recruiting
Led By Forrest Jellison, MD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.
Be older than 18 years old
Must not have
neurogenic bladder, BMI >40, or peripheral neuropathy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing the amount of radiation exposure between two groups during a sacral neuromodulation procedure.

Who is the study for?
This trial is for patients getting a sacral neuromodulation implant due to overactive bladder, which includes symptoms like urinary urgency, frequent urination at night, and possibly urge incontinence. It's not open to those with neurogenic bladder issues, a BMI over 40, or peripheral neuropathy.
What is being tested?
The study is comparing two ways of using fluoroscopy during the placement of a lead for bladder control: one uses the usual amount of radiation (conventional), while the other tries to reduce it (experimental). The goal is to see if less radiation works just as well.
What are the potential side effects?
Since this trial focuses on reducing radiation exposure during a procedure rather than testing drugs, side effects are related to standard risks from fluoroscopy such as skin irritation or burns but are expected to be lower in reduced-radiation group.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am getting a sacral neuromodulation device for my overactive bladder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a neurogenic bladder, my BMI is over 40, or I suffer from peripheral neuropathy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiation Exposure
Secondary study objectives
Inoperative complications
Operative times
Optimal lead placement
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Reduced Radiation FluoroscopyExperimental Treatment1 Intervention
Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.
Group II: Conventional FluoroscopyActive Control1 Intervention
The standard of care is the conventional fluoroscopy, the C-arm is set at 30 pulses-per-second and the current set as the default.

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
315 Previous Clinical Trials
266,546 Total Patients Enrolled
Forrest Jellison, MDPrincipal Investigator - Loma Linda University
Loma Linda University Children's Hospital, Loma Linda University Medical Center

Media Library

Conventional fluoroscopy (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT04527445 — N/A
Overactive Bladder Research Study Groups: Reduced Radiation Fluoroscopy, Conventional Fluoroscopy
Overactive Bladder Clinical Trial 2023: Conventional fluoroscopy Highlights & Side Effects. Trial Name: NCT04527445 — N/A
Conventional fluoroscopy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04527445 — N/A
~29 spots leftby Dec 2025
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