Abstract / Summary
Oral chemolysis dissolves uric acid stones without surgery, but success depends on regular urinary pH measurement, patient adherence and timely adjustment of the citrate dose. We assessed the feasibility and safety of oral chemolysis supported by the Progalit digital monitoring system in outpatient practice. In this prospective single-center observational study (enrollment January 2022–August 2025; follow-up to February 2026), 54 of 73 consecutively screened adults with suspected uric acid stones were included. Stone composition was assessed clinically (computed tomography (CT) attenuation, urinary pH, metabolic profile); no stone material was analyzed. Patients entered home urinary pH readings into the Progalit system, which generated citrate dose recommendations against a predefined target pH of 7.0-7.2; every recommendation took effect only after physician confirmation. We assessed protocol completion, monitoring adherence, completeness of entered data, stone dissolution, treatment duration and safety. All 54 patients completed the monitoring protocol. Moderate or high adherence was recorded in 46 patients (85.2%), and the median per-patient proportion of measurements within the 7.0-7.2 target was 45.6%. Complete dissolution was achieved in 35 patients (64.8%; 95% CI 50.6–77.3), a partial response in 7 (13.0%) and no clinically relevant response in 12 (22.2%). The complete dissolution rate did not significantly exceed the pre-specified historical proportion of 61.0% (exact binomial test, one-sided p = 0.335). The final outcome was confirmed by non-contrast CT in 31 patients (57.4%) and by ultrasound alone in 23 (42.6%). Median duration of active citrate therapy was 15.0 weeks (IQR 9.0–19.0); among complete responders, median time to documented dissolution was 9.0 weeks (IQR 7.0–14.0). The physician modified or rejected 16 of 5532 algorithm recommendations (0.29%). No serious adverse events, treatment discontinuations or episodes of sustained over-alkalinization occurred. Digitally supported oral chemolysis with the Progalit system was feasible in outpatient practice, was not associated with serious adverse events and provided structured urinary pH monitoring with full protocol completion. The single-arm design, the absence of stone composition analysis and CT confirmation of the outcome in only 57.4% of patients preclude any conclusion about comparative effectiveness. Multicenter randomized studies are needed for that purpose. Not applicable; this was an observational study and was not registered as a clinical trial.