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Novel Therapy with Intravesical Liposomes for Ulcerative Interstitial Cystitis/Painful Bladder Syndrome
Author(s) -
PETERS Kenneth M.,
HASENAU Deborah L.,
ANTHONY Michele,
KAUFMAN Jonathan,
KILLINGER Kim A.
Publication year - 2012
Publication title -
luts: lower urinary tract symptoms
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.451
H-Index - 15
eISSN - 1757-5672
pISSN - 1757-5664
DOI - 10.1111/j.1757-5672.2011.00108.x
Subject(s) - medicine , cystoscopy , interstitial cystitis , urology , adverse effect , liposome , clinical trial , surgery , urinary system , materials science , nanotechnology
Objectives: 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. Conclusion: 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.