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Radiation

Reduced Radiation Fluoroscopy for Overactive Bladder

N/A

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after surgery

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Radiation Exposure

Secondary outcome measures

Clinical Outcome assessed by validated questionnaire

Inoperative complications

Operative times

+2 more

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,944 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research protocol accommodate those over 25 years of age?

"Participants aged 18 or over, but under the age of 89 are eligible to enrol in this trial."

Answered by AI

Are investigators still recruiting for this research endeavor?

"Affirmative. Clinicaltrials.gov highlights that this medical investigation, which was posted on September 30th 2020, is still seeking applicants. A total of 44 candidates are required to be recruited from a single site."

Answered by AI

How many participants have been recruited for this experiment?

"Indeed, the clinical trial is currently recruiting. According to records on clinicialtrials.gov, this research was initially posted on September 30th 2020 and edited most recently November 29th 2022. To date, 44 patients have been accepted from 1 location."

Answered by AI

What population is eligible to participate in this clinical experiment?

"This medical trial is taking in 44 individuals aged 18 to 89 who suffer from urinary urge incontinence. The most pertinent requirement for enrolment is meeting the criteria of having an overactive bladder as described by urgency, frequency, and nocturia with or without urgency incontinence while undergoing lead implantation for sacral neuromodulation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

Forrest Jellison 2024. "Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04527445.

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