Prairie Loin Pain Hematuria Syndrome Renal Denervation Study: A Feasibility Study
Loin Pain-Hematuria Syndrome
About this trial
This is an interventional treatment trial for Loin Pain-Hematuria Syndrome focused on measuring Loin Pain, Renal Denervation, Endovascular ablation of renal nerves
Eligibility Criteria
Inclusion/ Exclusion Criteria
Inclusion criteria for patients to be invited to participate in the study are:
- ≥ 18 years of age
- Diagnosed with loin pain hematuria syndrome by a nephrologist, in consultation with a urologist.
- Current use of prescription pain medication for LPHS treatment
- Arteries with a diameter between 3 mm and 8 mm.
Exclusion criteria for patients to be screened out of the study are:
- History of kidney auto transplantation
- Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2
- Pregnant or nursing
- Need chronic oxygen support or mechanical ventilation via tracheostomy continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP)
- Renovascular abnormalities
- Prior renal angioplasty, indwelling renal stents and/or aortic stent grafts
- Evidence of a somatoform disorder as per the SCID-5
- Unavailable to travel to Regina, SK one day prior to the procedure to meet with the Principal Investigator and study coordinator
Sites / Locations
- Saskatchewan Health AuthorityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Renal angiography and Renal denervation
Renal angiography
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.
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.