NCT04332731

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

Active, enrolled NA Last updated 16 April 2024

What this trial tests

NA trial testing Symplicity Spyral™ multi electrode renal denervation system in Loin Pain-Hematuria Syndrome in 10 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 December 2020

Primary endpoint
31 July 2024

31 December 2024

Quick facts

Lead sponsor	Saskatchewan Health Authority - Regina Area
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	10
Start date	1 December 2020
Primary completion	31 July 2024
Estimated completion	31 December 2024
Sites	1 location across Canada

Drugs / interventions tested

• Symplicity Spyral™ multi electrode renal denervation system
• Renal angiogram

Conditions studied

• Loin Pain-Hematuria Syndrome — all drugs for Loin Pain-Hematuria Syndrome →

Sponsor

Saskatchewan Health Authority - Regina Area — full company profile →

Who can join

Adults 18 to 80, any sex, with Loin Pain-Hematuria Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility Study of a Randomized Controlled Trial Investigating Renal Denervation as a Possible Treatment Option in Patients With Loin Pain Hematuria Syndrome.
   Prasad B, Jafari M, Kour K, Goyal K, et al · · 2020 · cited 1× · PMID 32922827 · DOI 10.1177/2054358120951390