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

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called radiofrequency nerve ablation for young women with severe kidney pain from LPHS. The treatment uses heat to destroy nerves that send pain signals to the brain. The goal is to see if this method can effectively reduce pain without major surgery or heavy reliance on opioids. Radiofrequency nerve ablation has been explored as a treatment for LPHS, showing promise in reducing pain and medication use.

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+