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

Saskatchewan Health Authority - Regina Area · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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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
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