Reduced Radiation Fluoroscopy for Overactive Bladder

Overseen By Forrest Jellison, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Disqualifiers: Neurogenic bladder, BMI >40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: At time of procedure

44 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 6 7 8}

How 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). ^{2 3 4 6 7}

Research Team

Forrest Jellison, MD

Principal Investigator

Loma Linda University

Eligibility 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.

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)

Treatment Details

Interventions

• Conventional fluoroscopy
• Reduced radiation fluoroscopy

Trial Overview 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.

Participant Groups

Group I: Reduced Radiation Fluoroscopy Experimental Treatment 1 Intervention

Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.

Group II: Conventional Fluoroscopy Active Control 1 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

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Findings from Research

Pulsed fluoroscopy significantly reduces radiation exposure to pediatric patients by 50% compared to conventional fluoroscopy, with even greater reductions of up to 75% at 7.5 pulses-per-second.

Despite a slight increase in the number of digital spot films taken, pulsed fluoroscopy is preferred due to its safety benefits, making it the technique of choice for pediatric patients at the institution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of radiation dose in pediatric patients using pulsed fluoroscopy. Hernandez, RJ., Goodsitt, MM.[2022]

Pulsed fluoroscopy can significantly reduce radiation exposure, achieving up to 80% less radiation compared to continuous fluoroscopy, depending on the pulse rate used.

In clinical practice, 96% of examinations can be conducted using pulsed fluoroscopy, with the majority (78%) performed at lower pulse rates of 2 or 3 pulses per second, demonstrating its feasibility and effectiveness in routine procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Initial experiences with pulsed fluoroscopy on a multifunctional fluoroscopic unit]. Herrmann, K., Helmberger, T., Waggershauser, T., et al.[2007]

Pulsed fluoroscopy can significantly reduce radiation exposure for children during fluoroscopic studies, which is crucial for minimizing health risks associated with radiation.

Understanding the physics behind pulsed fluoroscopy is essential for radiologists, as lower pulse rates not only decrease radiation dose but also improve the quality of video frame-grabbed images.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the use of pulsed fluoroscopy to reduce radiation exposure to children. Cohen, MD.[2008]

In a study of 100 patients undergoing flexible ureterorenoscopy for kidney stones, operator-controlled imaging significantly reduced fluoroscopy time to an average of 33.5 seconds compared to 57.0 seconds for radiographer-controlled imaging, indicating a more efficient approach.

The findings suggest that using operator-controlled imaging not only enhances the independence of urologists during procedures but also minimizes radiation exposure, aligning with the ALARA principle to protect both patients and medical staff from potential long-term effects of radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can operator-controlled imaging reduce fluoroscopy time during flexible ureterorenoscopy? Henderickx, MMEL., Brits, T., Zabegalina, NS., et al.[2022]

A practice improvement project involving 316 patients demonstrated that using pulsed and low-dose fluoroscopy significantly reduced radiation exposure times by 56.7% during spinal interventions.

The study emphasizes the importance of combining pulsed fluoroscopy with other safety measures, such as lead shielding and increased distance from the radiation source, to minimize radiation exposure effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in average fluoroscopic exposure times for interventional spinal procedures through the use of pulsed and low-dose image settings. Goodman, BS., Carnel, CT., Mallempati, S., et al.[2016]

Pulsed fluoroscopy does not significantly reduce patient radiation exposure compared to conventional fluoroscopy, as shown in a study of 13 X-ray systems used in cardiac catheterization procedures.

However, using pulsed fluoroscopy at a lower pulse rate (below 25 pulses/sec) can lead to a significant reduction in skin dose, indicating that the effectiveness of pulsed fluoroscopy can vary based on the pulse rate and specific X-ray system used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient skin dose in cardiac interventional procedures: conventional fluoroscopy versus pulsed fluoroscopy. Chida, K., Fuda, K., Saito, H., et al.[2022]

Grid-controlled variable-rate pulsed fluoroscopy (GCPFL) significantly reduces radiation exposure during voiding cystourethrography (VCUG) in a pediatric porcine model, achieving reductions of 4.6 to 7.5 times lower than continuous fluoroscopy (CFL).

Despite the reduced radiation exposure with GCPFL, the diagnostic quality of VCUG images remained comparable to those obtained with CFL, indicating that GCPFL is a safer alternative without compromising image quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation exposure reduction during voiding cystourethrography in a pediatric porcine model of vesicoureteral reflux. Ward, VL., Barnewolt, CE., Strauss, KJ., et al.[2022]

In a study of 145 children aged 3 days to 8 years, voiding cystourethrography (VCUG) using grid-controlled variable-rate pulsed fluoroscopy (GCPFL) resulted in radiation exposure that was at least eight times lower than that of continuous fluoroscopy (CFL).

While GCPFL significantly reduced radiation exposure, the effective doses were still higher than those from radionuclide cystography (RNC), indicating that GCPFL is a safer option for children undergoing VCUG compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric radiation exposure and effective dose reduction during voiding cystourethrography. Ward, VL., Strauss, KJ., Barnewolt, CE., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Reduction of radiation dose in pediatric patients using pulsed fluoroscopy. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[Initial experiences with pulsed fluoroscopy on a multifunctional fluoroscopic unit]. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Optimizing the use of pulsed fluoroscopy to reduce radiation exposure to children. [2008]

4. Poland pubmed.ncbi.nlm.nih.gov

Can operator-controlled imaging reduce fluoroscopy time during flexible ureterorenoscopy? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Reduction in average fluoroscopic exposure times for interventional spinal procedures through the use of pulsed and low-dose image settings. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Patient skin dose in cardiac interventional procedures: conventional fluoroscopy versus pulsed fluoroscopy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Radiation exposure reduction during voiding cystourethrography in a pediatric porcine model of vesicoureteral reflux. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Pediatric radiation exposure and effective dose reduction during voiding cystourethrography. [2022]