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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using less radiation during a procedure for overactive bladder is as effective as the usual method. Participants will receive either the standard X-ray fluoroscopy or a reduced radiation technique while having a lead placed for sacral neuromodulation, a treatment for overactive bladder. The study will compare radiation exposure between the two groups. Individuals who frequently feel the need to urinate urgently, often, or wake up at night to urinate would be suitable candidates if they are undergoing this procedure. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment safety and effectiveness.

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 prior data suggests that these fluoroscopy techniques are safe for overactive bladder procedures?

Research has shown that pulsed fluoroscopy, similar to the reduced radiation fluoroscopy used in this trial, significantly lowers radiation exposure compared to the usual continuous method. This reduction enhances patient safety by minimizing risks linked to high radiation levels. Although data on fluoroscopy safety during sacral neuromodulation procedures is limited, existing research is encouraging. Reduced radiation techniques have kept radiation exposure lower than traditional methods while still ensuring accurate lead placement in the body. This suggests that the reduced radiation method is generally well-tolerated and safe for similar procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about reduced radiation fluoroscopy for overactive bladder because it significantly lowers radiation exposure compared to conventional fluoroscopy. The innovative technique uses the C-arm at just 1 pulse-per-second, drastically reducing the radiation dose patients receive. This could be a game-changer for patient safety, minimizing long-term risks associated with repeated radiation exposure while maintaining the effectiveness of bladder imaging.

What evidence suggests that reduced radiation fluoroscopy is effective for overactive bladder?

This trial will compare reduced radiation fluoroscopy with conventional fluoroscopy for treating overactive bladder. Research has shown that reduced radiation fluoroscopy can significantly decrease radiation exposure. Studies have found it can reduce radiation by up to 80% compared to standard methods. By using a setting that emits one pulse per second, both the radiation level and procedure time are lowered. This method is practical and has been shown to cut radiation exposure for the surgeon by 64%. These findings suggest that reduced radiation fluoroscopy effectively minimizes radiation risks during procedures. ^{1 4 6 7 8}

Who Is on the Research Team?

Forrest Jellison, MD

Principal Investigator

Loma Linda University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-urinary-incontinence-urge-8-2020-22a7a

Reduced Radiation Fluoroscopy for Overactive Bladder Pulsed fluoroscopy can significantly reduce radiation exposure, achieving up to 80% less radiation compared to continuous fluoroscopy, depending on the pulse ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5868228/

Radiation Reduction in Low Dose Pulsed Fluoroscopy ... Low dose pulsed fluoroscopy of 3 fps significantly reduces radiation exposure by about 600% compared with standard dose continuous fluoroscopy in FGLP.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.25408

Radiation exposure during sacral neuromodulation lead ... Objectives. Fluoroscopy has significantly improved lead placement and decreased surgical time for implantable sacral neuromodulation (SNM).

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S009042951730047X

Single Pulse-per-second Setting Reduces Fluoroscopy ... Conclusion. Single pps fluoroscopy is feasible, significantly reduces fluoroscopy time, and lowers surgeon radiation exposure by 64%.

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/20514158211002964

Reduced radiation fluoroscopy technique for implantation ... Results: RF settings resulted in significant reduction of radiation compared to CF settings, including the fluoroscopy time (8.61 vs. 48.16 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04527445

Fluoroscopy Radiation Reduction During Sacral ... During the surgery, the surgeon may change the settings from reduced radiation (intervention) to conventional fluoroscopy (control) to safely place lead. The ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38318969

Radiation exposure during sacral neuromodulation lead ... There is a paucity of data regarding radiation and safety of fluoroscopy during SNM procedures. Our study aims to characterize fluoroscopy ...

8. auajournals.org auajournals.org/doi/pdf/10.1097/01.JU.0001110032.39513.32.11

MP25-11 TURNING DOWN THE DOSE Reassuringly, radiation usage and exposure remained lower when compared to the pre-intervention period. These results suggest repeated reinforcement of safety ...