Feasibility Study of a Randomized Controlled Trial Investigating Renal Denervation as a Possible Treatment Option in Patients with Loin Pain Hematuria Syndrome
Bibliographic record
Abstract
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
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.037 | 0.037 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.006 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.005 | 0.003 |
| Insufficient payload (model declined to judge) | 0.010 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".