UnknownNot Applicable

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

Canada10 participantsStarted 2020-12-01

Plain-language 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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assess the proportion of participants undergo procedures (treatment or sham) within 6 months

Timeframe: From the start of the study to 6 months after

Assess the of proportion of randomized participants (treatment or control) who entirely complete the follow-up measures

Timeframe: From the date of procedure (for each patient) to 6 months after the procedure

Trial details

NCT IDNCT04332731

SponsorSaskatchewan Health Authority - Regina Area

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Loin Pain-Hematuria Syndrome trials