title: Liposomal bladder instillations for IC/BPS: an open-label clinical evaluation.
abstract: OBJECTIVE
  Intravesical instillation of liposomes is a potentially new therapeutic option for subjects with interstitial cystitis/bladder pain syndrome (IC/BPS). The aim of this study was to explore the safety and clinical outcomes of 4 weekly instillations of sphingomyelin liposomes in an open-label cohort of subjects with IC/BPS.
  
  
  METHODS
  Fourteen symptomatic IC/BPS subjects were treated with intravesical liposomes once a week for 4 weeks. Safety measurements included laboratory specimen collection, vital signs, post-void residual, and assessment of adverse events (AEs). Efficacy measurements included pain visual analog scales (VAS), voiding diaries, global response assessments (GRAs), and O'Leary-Sant Interstitial Cystitis Symptom and Problem Indices (ICSI and ICPI).
  
  
  RESULTS
  No treatment-related AEs were reported at any time over the course of the study. Urgency VAS scores significantly decreased at 4 weeks (p = 0.0029) and 8 weeks (p = 0.0112) post-treatment. Pain VAS scores significantly decreased at 4 weeks post-treatment (p = 0.0073). Combined ICSI and ICPI scores improved significantly at 4 and 8 weeks (p = 0.002 for both time points) post-treatment. Responses to GRA showed improvement at 4 weeks post-instillation. No significant decrease in urinary frequency was found.
  
  
  CONCLUSIONS
  Sphingomyelin liposome instillations were well tolerated in subjects with IC/BPS with no AEs attributed to the test article. Treatment was associated with improvements in pain, urinary urgency, and overall symptom scores. Placebo-controlled clinical trials are needed to assess this potential therapy for IC/BPS.
authors.affiliation: Department of Urology, Beaumont Health System, 3535 W. 13 Mile Road Suite 438, Royal Oak, MI, 48073, USA.
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Peters
authors.forename: Deborah
authors.initials: D
authors.lastname: Hasenau
authors.forename: Kim A
authors.initials: KA
authors.lastname: Killinger
authors.forename: Michael B
authors.initials: MB
authors.lastname: Chancellor
authors.forename: Michele
authors.initials: M
authors.lastname: Anthony
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kaufman
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D018856:Cystitis, Interstitial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008081:Liposomes / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D059408:Pain Management; D010147:Pain Measurement; D013109:Sphingomyelins / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D008081:Liposomes; D013109:Sphingomyelins