Safety and dose flexibility clinical evaluation of intravesical liposome in patients with interstitial cystitis or painful bladder syndrome

Abstract

To present single institution open-label experience with intravesical liposomes (LPs), a mucosal protective agent, in patients with interstitial cystitis/painful bladder syndrome (IC/PBS) and to assess the safety and efficacy on IC/PBS symptoms. A total of 17 symptomatic IC/PBS patients were treated with intravesical LPs (80 mg/40 mL distilled water) once a week for 4 weeks ( n = 12) or twice a week treatment for 4 weeks ( n = 5). The primary outcome was the change in the O’Leary-Sant Symptom/Problem score and O’Leary-Sant total Score from baseline to Week 4 and Week 8. Other outcome measurements included the changes in pain scale, urgency scale, voiding log, and patient global assessment. Both weekly and biweekly LP instillation regiments were well tolerated. The incidence of urinary incontinence, retention, or unanticipated adverse changes was not noted at any dose either during the treatment or at the 4-week follow-up. The O’Leary-Sant Symptom/Problem score, O’Leary-Sant total Score, and pain score were significantly improved from baseline at both dose regimens with added benefit with the biweekly regimen. Intravesical LPs treatment is safe and its efficacy has sustained duration. Furthermore large-scale, placebo-controlled studies are warranted to assess the efficacy for this promising new treatment for IC/PBS.