What is the mechanism of action of this treatment?

Loin Pain-Hematuria Syndrome (LPHS) is often treated with opioid medications and, in severe cases, surgical interventions such as renal auto-transplantation and nephrectomy. A promising alternative is radiofrequency nerve ablation, which works by disrupting nociceptive nerve signals responsible for pain transmission. This minimally invasive procedure targets the nerves that send pain signals from the kidneys to the brain, thereby reducing pain perception. This mechanism is crucial for LPHS patients as it offers significant pain relief without the need for more invasive surgeries or long-term opioid use, which can have substantial side effects and dependency issues.

What side effects are associated with this type of intervention?

Radiofrequency Nerve Ablation (RFA) for Loin Pain-Hematuria Syndrome (LPHS) is generally considered a minimally invasive procedure with a relatively low risk of complications. Common side effects include temporary pain at the site of the procedure, swelling, and bruising. Some patients may experience numbness or tingling in the treated area. Rare but more serious side effects can include infection, bleeding, and nerve damage, which may lead to persistent pain or sensory changes. Overall, RFA is seen as a safer alternative to more invasive surgical options like renal auto-transplantation and nephrectomy.

What prior FDA approvals exist?

There are no specific FDA-approved drugs or treatments for Loin Pain-Hematuria Syndrome (LPHS) that focus on disrupting nociceptive nerve signals, such as Radiofrequency Nerve Ablation. Current treatments for LPHS primarily involve opioid prescriptions and, in extreme cases, surgical interventions like renal auto-transplantation and auto-nephrectomy. Radiofrequency Nerve Ablation is being studied as a minimally invasive alternative to these more invasive procedures.

What other types of research exist?

Promising novel alternatives to Radiofrequency Nerve Ablation for Loin Pain-Hematuria Syndrome (LPHS) include renal auto-transplantation and auto-nephrectomy. These surgical options aim to denervate nociceptive impulses and have shown promising results in terms of pain relief, mood, disability, and quality of life. However, these procedures are more invasive compared to radiofrequency nerve ablation.

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Procedure

Renal Denervation for Loin Pain-Hematuria Syndrome

N/A

Waitlist Available

Led By Bhanu Prasad, MD

Research Sponsored by Saskatchewan Health Authority - Regina Area

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years of age

Current use of prescription pain medication for LPHS treatment

Must not have

Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2

Need chronic oxygen support or mechanical ventilation via tracheostomy continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of procedure (for each patient) to 6 months after the procedure

Summary

This trial tests a new treatment called radiofrequency nerve ablation for young women with severe kidney pain from LPHS. The treatment uses heat to destroy nerves that send pain signals to the brain. The goal is to see if this method can effectively reduce pain without major surgery or heavy reliance on opioids. Radiofrequency nerve ablation has been explored as a treatment for LPHS, showing promise in reducing pain and medication use.

Who is the study for?

This trial is for adults over 18 with Loin Pain Hematuria Syndrome, diagnosed by a nephrologist and urologist, who are currently on prescription pain meds. Participants must have certain artery sizes and can't join if they've had kidney transplants, are pregnant/nursing, have specific kidney issues or vascular abnormalities, need chronic oxygen support, or have a history of renal procedures.

What is being tested?

The study tests the Symplicity Spyral™ system's ability to perform radiofrequency nerve ablation as an alternative to opioids or surgery in LPHS patients. It's a double-blinded trial comparing this treatment against a sham procedure to see if it's feasible for larger trials.

What are the potential side effects?

While not explicitly listed here, side effects may include discomfort at the site of intervention, potential damage to blood vessels from the angiogram or denervation device, bleeding complications post-procedure and possible worsening of hypertension.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am currently taking prescription pain medication for LPHS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced, with an eGFR below 45.

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I need help breathing, like oxygen support or a ventilator.

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I have had a kidney auto transplantation.

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I have abnormalities in the blood vessels of my kidneys.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of procedure (for each patient) to 6 months after the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of procedure (for each patient) to 6 months after the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of procedure (for each patient) to 6 months after the procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

To assess the change from Baseline EQ-5D VAS at 6 months after procedure (treatment or control)

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

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Renal angiography and Renal denervationExperimental Treatment2 Interventions

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.

Group II: Renal angiographyPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Renal angiogram

2011

N/A

~540

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Loin Pain-Hematuria Syndrome (LPHS) is often treated with opioid medications and, in severe cases, surgical interventions such as renal auto-transplantation and nephrectomy. A promising alternative is radiofrequency nerve ablation, which works by disrupting nociceptive nerve signals responsible for pain transmission. This minimally invasive procedure targets the nerves that send pain signals from the kidneys to the brain, thereby reducing pain perception. This mechanism is crucial for LPHS patients as it offers significant pain relief without the need for more invasive surgeries or long-term opioid use, which can have substantial side effects and dependency issues.

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