RENAL DENERVATION IN LOIN PAIN HEMATURIA SYNDROME: A FEASIBILITY RANDOMIZED CONTROL TRIAL

8 Feb 2025 12 a.m. 12 a.m.
WCN25-AB-3548, Poster Board= SAT-268

Introduction:

Loin pain hematuria syndrome (LPHS) is characterized by intractable, unilateral, or bilateral loin pain that is localized to the kidney but not caused by any identifiable urinary tract disease. Renal denervation (RDN) is a promising treatment option for LPHS. While observational studies have shown promise, no RCTs have been conducted to date. To address this gap, we conducted a feasibility study comparing RDN with a sham arm.

Methods:

We conducted a single-centre, double-blind, parallel-group, partial crossover, sham-controlled, randomized feasibility trial after receiving approval from Health Canada. Patients with clinically diagnosed LPHS, on opiate pain medications for more than 3 months, and with suitable vasculature were enrolled to undergo RDN or sham procedure, with RDN offered to patients initially randomized to sham at 6 months follow-up. The primary outcome was to determine the proportion of randomized patients (treatment or control) who completed the follow-up measures at 6 weeks, 3, and 6 months.

Results:

We enrolled 13 patients who fulfilled the eligibility criteria. The first 3 patients underwent open-label RDN, and the subsequent 10 were randomized to RDN or sham procedure. The mean age was 39.2 years, and 12/13 patients were female and required 115.8 ± 106.5 mg of morphine. All patients successfully underwent the procedure within 6 months, with the cross-over group within 18 months of enrollment. 100% of patients in the roll-in and 80% in the treatment and sham group successfully completed follow-up evaluations. No adverse events were reported during the follow-up. There was no reduction in pain severity in the sham arm, but there was an improvement in the RDN and cross-over arms.

Table1- Patient characteristics

 

Characteristics

Roll in (n=3)

RDN (n=5)

Sham (n=5)

Cross-over (n=3)

Mean age

43.33±5.5

36±12.5

40±6

39±5.2

Sex (n, female)

3

4

5

3

BPI Percent reduction (baseline to 3 months)

78.8%

34.7%

-17.3%

57%

VAS % gain in scores (baseline to 3 months)

100.2%

60%

21.42%

60%

Conclusions:

Enrolling LPHS patients for a RCT of RDN was feasible, with RDN being safe during the follow-up period. This study paves the way for a larger multicenter study to further explore its efficacy.

I have no potential conflict of interest to disclose.

I did not use generative AI and AI-assisted technologies in the writing process.