Status:
ACTIVE_NOT_RECRUITING
Prairie Loin Pain Hematuria Syndrome Renal Denervation Study: A Feasibility Study
Lead Sponsor:
Saskatchewan Health Authority - Regina Area
Collaborating Sponsors:
University of Saskatchewan
Conditions:
Loin Pain-Hematuria Syndrome
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 ...
Detailed Description
Research Design and Methods This study is a double-blinded, parallel group, sham-controlled, randomized control, partial crossover feasibility trial. This feasibility trial is a part of a larger clin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04332731
Start Date
December 1 2020
End Date
December 31 2024
Last Update
April 16 2024
Active Locations (1)
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1
Saskatchewan Health Authority
Regina, Saskatchewan, Canada