Liposomal bladder instillations for IC/BPS: an open-label clinical evaluation

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• 作者：Kenneth M. Peters (1) (2)
  Deborah Hasenau (1)
  Kim A. Killinger (1)
  Michael B. Chancellor (1) (2) (3)
  Michele Anthony (3)
  Jonathan Kaufman (3)
  
• 关键词：Cystitis ; Interstitial ; Administration ; Intravesical ; Liposome
• 刊名：International Urology and Nephrology
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：46
• 期：12
• 页码：2291-2295
• 全文大小：266 KB
• 参考文献：1. Nordling J (2004) Interstitial cystitis: How should we diagnose it and treat it in 2004? Curr Opin Urol 14:323-27 CrossRef
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  9. Kaufman J, Tyagi V, Anthony M et al (2010) State of the art in intravesical therapy for lower urinary tract symptoms. Rev Urol 12:e181–e189
  10. Hill WG, Zeidel ML (2000) Reconstituting the barrier properties of a water-tight epithelial membrane by design of leaflet-specific liposomes. J Biol Chem 275:30176-0185 CrossRef
  11. Tyagi P, Hsieh VC, Yoshimura N et al (2009) Instillation of liposomes vs dimethyl sulphoxide or pentosan polysulphate for reducing bladder hyperactivity. BJU Int 104:1689-692 CrossRef
  12. Chuang YC, Lee WC, Lee WC et al (2009) Intravesical liposome versus oral pentosan polysulfate for interstitial cystitis/painful bladder syndrome. J Urol 182:1393-400 CrossRef
  13. Peters KM, Hasenau DL, Anthony M et al (2012). Novel therapy with intravesical liposomes for ulcerative interstitial cystitis/painful bladder syndrome. LUTS: Lower Urinary Tract Symptoms 4: 51-3
  
• 作者单位：Kenneth M. Peters (1) (2)
  Deborah Hasenau (1)
  Kim A. Killinger (1)
  Michael B. Chancellor (1) (2) (3)
  Michele Anthony (3)
  Jonathan Kaufman (3)
  
  1. Department of Urology, Beaumont Health System, 3535 W. 13 Mile Road Suite 438, Royal Oak, MI, 48073, USA
  2. Department of Urology, Oakland University William Beaumont School of Medicine, Rochester Hills, MI, USA
  3. Lipella Pharmaceuticals Inc., Pittsburgh, PA, 15217, USA
  
• ISSN：1573-2584

文摘

Purpose 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.