10 Participants Needed

Renal Denervation for Loin Pain-Hematuria Syndrome

BP
Overseen ByBhanu Prasad, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Saskatchewan Health Authority - Regina Area
Must be taking: Pain medication
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

Research Team

BP

Bhanu Prasad, MD

Principal Investigator

Saskatchewan Health Authority - Regina Area

Eligibility Criteria

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 am 18 years old or older.
I have been diagnosed with loin pain hematuria syndrome by kidney and urinary tract doctors.
I am currently taking prescription pain medication for LPHS.
See 1 more

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.
See 5 more

Timeline

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

Treatment Details

Interventions

  • Symplicity Spyral™ multi electrode renal denervation system
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Renal angiography and Renal denervationExperimental Treatment2 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 angiographyPlacebo Group1 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.

Find a Clinic Near You

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+