A Prospective, Multicenter, Real-world Effectiveness and Safety Study of High Molecular Weight Sodium Hyaluronate for Interstitial Cystitis/Bladder Pain Syndrome

Purpose This prospective, multicentre, effectiveness study evaluated the performance and safety of high molecular weight sodium hyaluronate (40mg/50mL) in real-world clinical practice among patients with interstitial cystitis/bladder pain syndrome (IC/BPS). Methods This prospective, multicenter European study was conducted in patients with a clinical diagnosis of IC/BPS. Participants received weekly intravesical instillations for approximately 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. Results Of 74 patients enrolled, 71 patients were part of the full analysis set (mean [SD] age: 51.8 [16.9] years; 98.6% female) and 73 patients in the safety set (mean [SD] age: 51.9 [17.2] years; 98.6% female). The 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 (+ 17.1; +27.2, all P < .0001). Twenty patients (27.4%) reported 37 adverse events (AEs), including seven treatment-related incidents. No serious related AEs occurred; one unrelated serious AE (fever) was reported. All AEs were resolved.All incidents and AEs were resolved. Conclusions Intravesical HMW sodium hyaluronate improved IC/BPS symptoms and quality of life through week 24, with a favorable safety profile.