title: Novel Therapy with Intravesical Liposomes for Ulcerative Interstitial Cystitis/Painful Bladder Syndrome.
abstract: OBJECTIVE
  A Federal Drug Administration-approved, compassionate-use, investigational new drug single-subject trial was conducted to evaluate the safety and clinical outcomes of intravesical instillation of liposomes in a woman with ulcerative interstitial cystitis/painful bladder syndrome (IC/PBS).
  
  
  METHODS
  After obtaining informed consent, the 48-year-old woman, diagnosed with ulcerative IC/PBS, received four weekly instillations of intravesical liposomes. Subsequently she was evaluated for 8 weeks post bladder instillation.
  
  
  RESULTS
  No side effects or adverse events were reported during the 12 week study period. Voids per day decreased from a baseline of 18 voids per 24 h to 11.3 voids per 24 h at week 3, and 12.6 voids per 24 h at 8 weeks after final instillation. Urgency score also decreased from a pre-instillation mean of 1.75 (out of 10) to 1.07 8 weeks after the final instillation. Bladder ulcers noted by cystoscopy at baseline were absent at the 8 weeks post-treatment and no evidence of bladder inflammation was noted.
  
  
  CONCLUSIONS
  Intravesical liposome instillation is minimally invasive and presents an appealing new treatment for IC/PBS. Prospective trials are needed to assess intravesical liposomes for IC/PBS.
authors.affiliation: Department of Urology, William Beaumont Hospital, Royal Oak, Michigan, USALipella Pharmaceuticals, Inc., Pittsburgh, Pennsylvania, USA.
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Peters
authors.affiliation: Department of Urology, William Beaumont Hospital, Royal Oak, Michigan, USALipella Pharmaceuticals, Inc., Pittsburgh, Pennsylvania, USA.
authors.forename: Deborah L
authors.initials: DL
authors.lastname: Hasenau
authors.affiliation: Department of Urology, William Beaumont Hospital, Royal Oak, Michigan, USALipella Pharmaceuticals, Inc., Pittsburgh, Pennsylvania, USA.
authors.forename: Michele
authors.initials: M
authors.lastname: Anthony
authors.affiliation: Department of Urology, William Beaumont Hospital, Royal Oak, Michigan, USALipella Pharmaceuticals, Inc., Pittsburgh, Pennsylvania, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kaufman
authors.affiliation: Department of Urology, William Beaumont Hospital, Royal Oak, Michigan, USALipella Pharmaceuticals, Inc., Pittsburgh, Pennsylvania, USA.
authors.forename: Kim A
authors.initials: KA
authors.lastname: Killinger
keywords: interstitial cystitis; intravesical instillation; liposomes; urinary bladder