Prairie Loin Pain Hematuria Syndrome Renal Denervation Study: A Feasibility Study

Summary

Loin Pain Hematuria Syndrome (LPHS) is a poorly understood, painful and incapacitating condition that typically afflicts young women and was first described in 1967. Currently, the treatment for LPHS is opioid prescription and in some extreme cases, surgical denervation of the nociceptive impulses with renal auto transplantation and auto nephrectomy.

Radiofrequency nerve ablation is a minimally invasive alternative to opiate therapy, auto-transplantation and nephrectomy in LPHS. In the investigators' previous exploratory pre/post single centre studies, the investigators showed promising results with regards to pain relief, mood, disability and quality of life post procedure. As these initial studies were neither blinded nor randomized, improvements in pain and quality of life scores owing to a placebo effect cannot be ruled out ; hence, to rule out any cause-effect relation between treatment and outcome, selection-bias, influences the investigators intend to conduct a double-blinded, parallel group, sham-controlled, randomized controlled trial (RCT). The present study is designed to assess the feasibility of conducting a large scale randomized control trial.

Study Hypothesis: In the present study the investigators hypothesize that the recruitment, intervention, measurement and trial procedures will be feasible and acceptable, thus allowing to proceed with a full randomized control trial

Conditions

• Loin Pain-Hematuria Syndrome

Interventions

DEVICE

Symplicity Spyral™ multi electrode renal denervation system

Symplicity Spyral™ multi-electrode renal denervation catheter (Symplicity Spyral catheter, Medtronic) and associated Symplicity G3™ renal denervation radiofrequency generator (Symplicity G3 generator, Medtronic) will be used in this study. The Symplicity Spyral™ multi-electrode renal denervation catheter is intended to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.

DIAGNOSTIC_TEST

Renal angiogram

Renal angiogram will be used in both treatment and sham groups. Renal angiography is an imaging test used to study the blood vessels in the kidneys. The test will examine the kidney artery anatomy using x-rays following the injection of an x-ray dye (contrast medium). Only patients with eligible renal artery anatomy (between 3 mm and 8 mm) will be randomized ( to treatment or sham groups).

Sponsors & Collaborators

• University of Saskatchewan

  collaborator OTHER

• Saskatchewan Health Authority - Regina Area

  lead OTHER

Principal Investigators

• Bhanu Prasad, MD · Saskatchewan Health Authority - Regina Area

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-01

Primary Completion

2024-07-31

Completion

2024-12-31

FDA Device

Yes

Countries

• Canada

Study Locations