Renal Denervation for Loin Pain-Hematuria Syndrome

Overseen By Bhanu Prasad, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Saskatchewan Health Authority - Regina Area

Must be taking: Pain medication

Disqualifiers: Kidney transplant, Low eGFR, Pregnant, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with Loin Pain Hematuria Syndrome (LPHS), a condition causing severe pain and blood in the urine. Researchers are investigating whether renal denervation, a procedure using radio waves to disrupt pain signals, can provide relief without strong pain medications or surgery. The Symplicity Spyral™ multi-electrode renal denervation system will perform this procedure. Participants will receive either this treatment or a sham procedure for comparison. Those diagnosed with LPHS, currently using prescription pain medication, and with suitable arteries might be eligible.

As an unphased study, this trial presents a unique opportunity to explore innovative treatment options for LPHS.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must currently be using prescription pain medication for treatment, so you may need to continue those.

What prior data suggests that the Symplicity Spyral™ multi electrode renal denervation system is safe for treating Loin Pain Hematuria Syndrome?

Research shows that the Symplicity Spyral™ system, which uses radio waves to target nerves in the kidney, is generally well-tolerated by patients. Earlier studies and reports found this treatment to be a safe option.

These studies also examined its use for other conditions and found it safe, with no serious side effects reported. Although these studies did not specifically address Loin Pain Hematuria Syndrome, they provide some reassurance about the treatment's safety. Any minor side effects were manageable and temporary.

Overall, while more research is needed specifically for Loin Pain Hematuria Syndrome, current evidence suggests that the treatment is safe and could serve as a good alternative to more invasive options. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for loin pain-hematuria syndrome, which often involve pain management and sometimes kidney removal, the Symplicity Spyral™ system offers a novel approach through renal denervation. This technique targets overactive nerves in the kidneys, which are believed to contribute to the pain and blood in urine associated with the condition. Researchers are excited because this method could provide significant relief by directly addressing the nerve activity, potentially offering a non-surgical alternative with fewer side effects.

What evidence suggests that the Symplicity Spyral™ multi electrode renal denervation system is effective for Loin Pain Hematuria Syndrome?

Research suggests that the Symplicity Spyral™ system for renal denervation might help treat Loin Pain-Hematuria Syndrome (LPHS). Earlier studies showed that this method could reduce pain and improve patients' quality of life. In this trial, participants in one arm will undergo renal denervation using the Symplicity Spyral™ system, which uses radio waves to target nerves in the kidney, potentially lowering pain signals. Although initial results are promising, these studies were not blinded or randomized, so the results might be influenced by a placebo effect. More research is needed to confirm these findings in larger, controlled trials. ^{2 3 4 5 6}

Who Is on the Research Team?

Bhanu Prasad, MD

Principal Investigator

Saskatchewan Health Authority - Regina Area

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Loin Pain Hematuria Syndrome, diagnosed by a nephrologist and urologist, who are currently on prescription pain meds. Participants must have certain artery sizes and can't join if they've had kidney transplants, are pregnant/nursing, have specific kidney issues or vascular abnormalities, need chronic oxygen support, or have a history of renal procedures.

Inclusion Criteria

I have been diagnosed with loin pain hematuria syndrome by kidney and urinary tract doctors.

I am currently taking prescription pain medication for LPHS.

My arteries are between 3 mm and 8 mm wide.

Exclusion Criteria

You have been diagnosed with a somatoform disorder using the SCID-5 assessment.

My kidney function is reduced, with an eGFR below 45.

I need help breathing, like oxygen support or a ventilator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either renal denervation or a sham procedure under general anesthesia

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 weeks, 3 months, and 6 months

6 months

Multiple visits (in-person and phone)

Open-label extension

Participants in the sham group may opt to receive the renal denervation procedure after the 6-month follow-up

Post 6-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Symplicity Spyral™ multi electrode renal denervation system

Trial Overview The study tests the Symplicity Spyral™ system's ability to perform radiofrequency nerve ablation as an alternative to opioids or surgery in LPHS patients. It's a double-blinded trial comparing this treatment against a sham procedure to see if it's feasible for larger trials.

How Is the Trial Designed?

Group I: Renal angiography and Renal denervation Experimental Treatment 2 Interventions

Symplicity Spyral™ multi electrode renal denervation system After renal angiography, participants in the experimental group will be immediately treated with renal denervation procedure using standard techniques. The participants will remain blinded throughout the procedure.

Group II: Renal angiography Placebo Group 1 Intervention

In the control group, the sham procedure will consist of only a renal angiogram. Participants will undergo diagnostic renal angiogram but will not receive any therapeutic endovascular treatment. Participants will remain on the procedure table for at least 20 min after the angiogram to prevent possible unblinding of randomization allocation.

Who Is Running the Clinical Trial?

Saskatchewan Health Authority - Regina Area

Lead Sponsor

Trials

29

Recruited

5,400+

University of Saskatchewan

Collaborator

Trials

261

Recruited

156,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7453461/

Feasibility Study of a Randomized Controlled Trial ... Case reports and series have shown renal denervation via catheter-based radiofrequency ablation to be an effective therapeutic option for the treatment of LPHS.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04332731

Prairie Loin Pain Hematuria Syndrome Renal Denervation ... The Symplicity Spyral™ multi-electrode renal denervation catheter is intended to deliver low-level radio frequency (RF) energy through the wall of the renal ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/31/NCT04332731/Prot_000.pdf

Protocol Loin Pain Hematuria Syndrome (LPHS) is a rare and poorly understood clinical condition characterized by severe, unilateral or bilateral loin pain localized ...

4. withpower.com withpower.com/trial/phase-syndrome-11-2020-ad4c0

Renal Denervation for Loin Pain-Hematuria Syndrome Trial Overview The study tests the Symplicity Spyral™ system's ability to perform radiofrequency nerve ablation as an alternative to opioids or surgery in LPHS ...

5. medtronic.com medtronic.com/content/dam/medtronic-wide/public/united-states/products/surgical-energy/ablation/symplicity-spyral-renal-denervation-system-clinical-data.pdf

Symplicity Spyral™ renal denervation system - Clinical data Long-term safety and efficacy of renal denervation with the Symplicity Spyral catheter in the Global SYMPLICITY. Registry. Presented at American Society of ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220026B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The warnings and precautions can be found in the Symplicity Spyral multi-electrode renal denervation catheter and Symplicity G3 RF generator ...