Abstract: SA-PO1041
Feasibility Study of a Randomized Controlled Trial Investigating Renal Denervation as a Possible Treatment Option in Patients with Loin Pain Hematuria Syndrome
Session Information
- Women's Health and Kidney Diseases
October 26, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Women's Health and Kidney Diseases
- 2200 Women's Health and Kidney Diseases
Authors
- Prasad, Bhanu, Regina General Hospital, Regina, Saskatchewan, Canada
- Garg, Aarti, University of Regina, Regina, Saskatchewan, Canada
- Sharma, Aditi, University of Regina, Regina, Saskatchewan, Canada
Background
Loin Pain Hematuria Syndrome (LPHS) is a poorly understood clinical condition characterized by severe pain localized to the kidney but in the absence of identifiable urinary tract disease. Several studies have shown promise in observational studies but have been unable to replicate the results when compared with a sham arm in a randomized controlled trial. To address this gap, we conducted a feasibility study that involved a randomized controlled trial comparing renal denervation (RDN) with a sham arm. The primary objectives were to ensure that 80% of the study patients underwent the procedure (roll-in, treatment or sham) within 6 months and that 80% of the randomized patients (treatment or sham) completed the follow-up measures at 6 weeks, 3 and 6 months.
Methods
We conducted a single-center double-blinded, parallel-group, partial crossover, sham-controlled, randomized feasibility trial. 13 LPHS patients who required >100 mg of morphine milligram equivalent were randomized (treatment or control or roll-in) and they completed the follow-up for 6 months. The participants who received the sham procedure were crossed over into the treatment group and were followed for 6 months. The pain was assessed using Brief Pain Inventory Score (BPI) and quality of life was measured by EuroQol-5D and SF-36.
Results
100% of patients underwent the procedure within the initial 6-month period. 100% patients in the roll-in and 80% each in the treatment and sham group completed the follow-up assessments throughout the study duration. Improvements in pain severity and interference seem to have continued up to the 3-month follow-up in roll-in, RDN, and crossover. Percentage gain in VAS at 3 months was 100%, 60%, and 60% respectively (Table 1).
Conclusion
This is the first randomized controlled study that shows that RDN is associated with improvement in pain and quality of life. Our results suggest that percutaneous catheter-based radiofrequency energy delivery is a safe, rapid treatment option for all patients with LPHS.
| Characteristics | Roll in (n=3) | RDN (n=5) | Sham (n=5) | Cross-over (n=3) |
| Mean age (years) | 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% | 21.4% | 60% |
RDN: renal denervation; BPI: brief pain inventory