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

NCT04332731 | Active Not Recruiting DMC FDA Device

• 1 other identifier: REB-17-88
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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

Keywords

Loin Pain; Renal Denervation; Endovascular ablation of renal nerves

Outcome Measures

Primary Outcomes (2)

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

  We will consider the trial to be feasible if 80% of the target population (10 patients) undergoes procedure (treatment or sham) within 6 months

  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

  We will consider the trial to be feasible if 80% of randomized participants (treatment or control) remain in the trial and entirely complete the follow-up measures.

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

Secondary Outcomes (8)

• To assess the change from Baseline morphine-equivalent daily dosage of medication at 6 months after procedure (treatment or control)

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

• To assess the change from Baseline McGill Pain score at 6 months after procedure (treatment or control)

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

• To assess the change from Baseline pain severity score_Brief Pain Inventory at 6 months after procedure (treatment or control)

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

• To assess the change from Baseline pain interference score _Brief Pain Inventory at 6 months after procedure (treatment or control)

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

• To assess the change from Baseline CES-D score at 6 months after procedure (treatment or control)

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

Study Arms (2)

Renal angiography and Renal denervation

EXPERIMENTAL

Symplicity Spyral™ multi electrode renal denervation system After renal angiography, participants in the experimental group will be immediately treated with renal denervation procedure using standard techniques. The participants will remain blinded throughout the procedure.

Device: Symplicity Spyral™ multi electrode renal denervation system; Diagnostic Test: Renal angiogram

Renal angiography

SHAM COMPARATOR

In the control group, the sham procedure will consist of only a renal angiogram. Participants will undergo diagnostic renal angiogram but will not receive any therapeutic endovascular treatment. Participants will remain on the procedure table for at least 20 min after the angiogram to prevent possible unblinding of randomization allocation.

Diagnostic Test: Renal angiogram

Interventions

Symplicity Spyral™ multi electrode renal denervation system DEVICE

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.

Also known as: Renal denervation system

Renal angiography and Renal denervation

Renal angiogram DIAGNOSTIC_TEST

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).

Also known as: Kidney angiogram

Renal angiography; Renal angiography and Renal denervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• ≥ 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.
• 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

Sponsors & Collaborators

• Saskatchewan Health Authority - Regina Area: lead
• University of Saskatchewan: collaborator

Study Sites (1)

Saskatchewan Health Authority

Regina, Saskatchewan, Canada

Location

Related Publications (3)

• Prasad B, Giebel S, Garcia F, Goyal K, St Onge JR. Renal Denervation in Patients With Loin Pain Hematuria Syndrome. Am J Kidney Dis. 2017 Jan;69(1):156-159. doi: 10.1053/j.ajkd.2016.06.016. Epub 2016 Aug 12.

  PMID: 27528372 BACKGROUND

• Prasad B, Giebel S, Garcia F, Goyal K, Shrivastava P, Berry W. Successful Use of Renal Denervation in Patients With Loin Pain Hematuria Syndrome-The Regina Loin Pain Hematuria Syndrome Study. Kidney Int Rep. 2018 Feb 2;3(3):638-644. doi: 10.1016/j.ekir.2018.01.006. eCollection 2018 May.

  PMID: 29854971 BACKGROUND

• Prasad B, Jafari M, Kour K, Goyal K, Garcia F. Feasibility Study of a Randomized Controlled Trial Investigating Renal Denervation as a Possible Treatment Option in Patients With Loin Pain Hematuria Syndrome. Can J Kidney Health Dis. 2020 Aug 26;7:2054358120951390. doi: 10.1177/2054358120951390. eCollection 2020.

  PMID: 32922827 DERIVED

Study Officials

• Bhanu Prasad, MD

  Saskatchewan Health Authority - Regina Area

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The clinical staff (Nephrologist and Nurse) will be blinded to which patients are allocated to the randomized treatment and control groups. Only the interventional radiologist will know at the time of the procedure which group the patient has been assigned to. The radiologist will not be involved with patient follow up following the procedure. This way, the clinical follow-up will not be affected by clinician or patient knowledge of specific patient treatment. Unblinding will occur after the six-month follow-up assessment. The patient will be told the type of treatment received and, if they were allocated to the sham arm, will be offered the opportunity to undergo the RDN procedure. The patient treatment allocation will not be revealed until after the patient's six month follow-up period is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly allocated to one of two arms: 1) renal denervation (treatment group) or 2) sham (control group). The experimental group patients will receive a single treatment with radiofrequency ablation applied bilaterally. Similar to the treatment arm, sham patients will be given general anesthesia. The steps will be similar in the sham arm.

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 3, 2020
• Study Start: December 1, 2020
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)