Reduced Radiation Fluoroscopy for Overactive Bladder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Loma Linda University
Disqualifiers: Neurogenic bladder, BMI >40, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Reduced Radiation Fluoroscopy for Overactive Bladder?
Research shows that pulsed fluoroscopy can significantly reduce radiation exposure compared to continuous fluoroscopy, making it a safer option for patients. Studies have demonstrated its effectiveness in lowering radiation doses in both children and adults during various medical procedures.
12345Is reduced radiation fluoroscopy safe for humans?
Research shows that pulsed fluoroscopy, a type of reduced radiation fluoroscopy, generally lowers radiation exposure compared to conventional methods. This reduction in radiation has been observed in various medical procedures, suggesting it is a safer option for reducing radiation risks in humans.
12678How does reduced radiation fluoroscopy differ from other treatments for overactive bladder?
Reduced radiation fluoroscopy is unique because it uses a lower dose of radiation compared to conventional fluoroscopy, making it safer for patients by minimizing their exposure to radiation. This approach is particularly beneficial in procedures where fluoroscopy is needed, as it adheres to the principle of keeping radiation 'As Low As Reasonably Achievable' (ALARA).
23467Eligibility Criteria
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.Inclusion Criteria
I am getting a sacral neuromodulation device for my overactive bladder.
Exclusion Criteria
I have a neurogenic bladder, my BMI is over 40, or I suffer from peripheral neuropathy.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo sacral neuromodulation lead placement with either reduced or conventional fluoroscopy settings
At time of procedure
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a voiding log
3 months
1 visit (in-person)
Participant Groups
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.
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.
Conventional fluoroscopy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Fluoroscopy for:
- Diagnostic imaging
- Orthopedic procedures
- Cardiac catheterization
- Gastrointestinal examinations
🇺🇸 Approved in United States as Fluoroscopy for:
- Diagnostic imaging
- Orthopedic procedures
- Cardiac catheterization
- Gastrointestinal examinations
- Sacral neuromodulation lead placement
🇨🇦 Approved in Canada as Fluoroscopy for:
- Diagnostic imaging
- Orthopedic procedures
- Cardiac catheterization
- Gastrointestinal examinations
🇯🇵 Approved in Japan as Fluoroscopy for:
- Diagnostic imaging
- Orthopedic procedures
- Cardiac catheterization
- Gastrointestinal examinations
🇨🇳 Approved in China as Fluoroscopy for:
- Diagnostic imaging
- Orthopedic procedures
- Cardiac catheterization
- Gastrointestinal examinations
🇨🇭 Approved in Switzerland as Fluoroscopy for:
- Diagnostic imaging
- Orthopedic procedures
- Cardiac catheterization
- Gastrointestinal examinations
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Loma Linda University HealthLoma Linda, CA
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Who Is Running the Clinical Trial?
Loma Linda UniversityLead Sponsor
References
Reduction of radiation dose in pediatric patients using pulsed fluoroscopy. [2022]The purpose of this study was to determine if pulsed fluoroscopy reduces radiation exposure to pediatric patients undergoing conventional fluoroscopy.
[Initial experiences with pulsed fluoroscopy on a multifunctional fluoroscopic unit]. [2007]Comparison of radiation doses in pulsed and continuous fluoroscopy to quantify the dose reduction by pulsed fluoroscopy. Further, the applicability of pulsed fluoroscopy in clinical routine has been evaluated.
Optimizing the use of pulsed fluoroscopy to reduce radiation exposure to children. [2008]Radiologists desire to keep radiation dose as low as possible. Pulsed fluoroscopy provides an opportunity to lower radiation exposure to children undergoing fluoroscopic studies. To optimize the ability of pulsed fluoroscopy to decrease radiation dose to patients during fluoroscopic studies, radiologists need to understand how pulsed fluoroscopy operates. This report reviews the basic physics knowledge needed by radiologists to best use pulsed fluoroscopy to minimize radiation dose. It explains the paradox that the best video frame-grabbed images are obtained when using the lowest fluoroscopy pulse rate and therefore the lowest fluoroscopy radiation dose.
Can operator-controlled imaging reduce fluoroscopy time during flexible ureterorenoscopy? [2022]Fluoroscopy is routinely used during ureterorenoscopy. According to the 'As Low As Reasonably Achievable' (ALARA) principle, radiation exposure should be kept as low as reasonably achievable to decrease the risk of negative long-term effects of radiation for patients and medical staff. This study aims to assess if operator-controlled imaging during flexible ureterorenoscopy for nephrolithiasis could reduce fluoroscopy time when compared to radiographer-controlled imaging.
Reduction in average fluoroscopic exposure times for interventional spinal procedures through the use of pulsed and low-dose image settings. [2016]A practice improvement project was completed with the goal of reducing radiation exposure times in a busy spinal intervention practice through the use of "pulsed" and "low-dose fluoroscopy." The goal was to quantify the reduction in fluoroscopy exposure times with these modes.
Patient skin dose in cardiac interventional procedures: conventional fluoroscopy versus pulsed fluoroscopy. [2022]To investigate whether pulsed fluoroscopy reduces a patient's exposure compared with the exposure owing to conventional (continuous) fluoroscopy, we simulated the skin radiation doses of patients at cardiac catheterization facilities with various X-ray systems used in fluoroscopically guided intervention procedures.
Radiation exposure reduction during voiding cystourethrography in a pediatric porcine model of vesicoureteral reflux. [2022]To compare grid-controlled variable-rate pulsed fluoroscopy (GCPFL) and continuous fluoroscopy (CFL) for the reduction of radiation exposure during voiding cystourethrography (VCUG) in a pediatric porcine model of vesicoureteral reflux.
Pediatric radiation exposure and effective dose reduction during voiding cystourethrography. [2022]To compare radiation exposure and effective dose in children who underwent voiding cystourethrography (VCUG) performed with grid-controlled variable-rate pulsed fluoroscopy (GCPFL) with radiation exposure and effective dose in children who underwent VCUG performed with continuous fluoroscopy (CFL) and to compare these effective doses with those estimated with radionuclide cystography (RNC).