A prospective, multicenter, real-world effectiveness and safety study of high molecular weight sodium hyaluronate for interstitial cystitis/bladder pain syndrome

PURPOSE: The aim of the present study was to evaluate the performance and safety of high molecular weight (HMW) sodium hyaluronate (40 mg/50 mL) for interstitial cystitis/bladder pain syndrome (IC/BPS) in real-world clinical practice. METHODS: This prospective, multicenter European study was conducted in patients with the clinical diagnosis of IC/BPS. Participants received weekly intravesical instillations for 12 weeks. The primary endpoint was responder rate at end of treatment/week 12, defined as any improvement in IC/BPS symptoms on the 7-point Patient Global Assessment (PGA) scale. Secondary endpoints included changes in bladder symptoms and quality of life assessed by visual analog scales (VAS), questionnaires, and voiding diaries at week 12 and 24. RESULTS: Seventy-one (N = 74) patients enrolled were part of the full analysis set (mean [SD] age: 51.8 [16.9] years; 98.6% female) and 73/74 patients were in the safety set (mean [SD] age: 51.9 [17.2] years; 98.6% female). Total responder rate was 90.1% (90% CI: 82.3, 95.3) at week 12 and 78.9% (90% CI: 69.4, 86.5) at week 24. Significant improvements from baseline were observed in VAS scores for urinary urgency and bladder pain at week 12 (-42.0; -39.3) and week 24 (-49.2; -49.2). Quality of life scores also improved significantly (+ 17.1; + 27.2, all P < .0001). Twenty patients (27.4%) reported 37 adverse events (AEs), including seven treatment-related AEs (incidents). No treatment-related serious AEs occurred and all incidents were resolved. CONCLUSIONS: Intravesical HMW sodium hyaluronate improved IC/BPS symptoms and quality of life through week 24 in most patients with a favorable safety profile.