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

  • Urology - Original Paper
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Abstract

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.

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Acknowledgments

Authors received funding from the National Institutes of Health DK085733.

Conflict of interest

KMP, DH, and KAK declare no conflict of interest. MBC is inventor and chief scientific officer for Lipella Pharmaceuticals, Inc. MA and JK are employed by Lipella Pharmaceuticals, Inc.

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Authors and Affiliations

  1. Department of Urology, Beaumont Health System, 3535 W. 13 Mile Road Suite 438, Royal Oak, MI, 48073, USA

    Kenneth M. Peters, Deborah Hasenau, Kim A. Killinger & Michael B. Chancellor

  2. Department of Urology, Oakland University William Beaumont School of Medicine, Rochester Hills, MI, USA

    Kenneth M. Peters & Michael B. Chancellor

  3. Lipella Pharmaceuticals Inc., Pittsburgh, PA, 15217, USA

    Michael B. Chancellor, Michele Anthony & Jonathan Kaufman

Authors
  1. Kenneth M. Peters
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  2. Deborah Hasenau
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  3. Kim A. Killinger
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  4. Michael B. Chancellor
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  5. Michele Anthony
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  6. Jonathan Kaufman
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Corresponding author

Correspondence to Kim A. Killinger.

Additional information

ClinicalTrial.gov Identifier: NCT01731470.

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Peters, K.M., Hasenau, D., Killinger, K.A. et al. Liposomal bladder instillations for IC/BPS: an open-label clinical evaluation. Int Urol Nephrol 46, 2291–2295 (2014). https://doi.org/10.1007/s11255-014-0828-5

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  • DOI: https://doi.org/10.1007/s11255-014-0828-5

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