Novel Therapy with Intravesical Liposomes for Ulcerative Interstitial Cystitis/Painful Bladder Syndrome

Authors


  • ClinicalTrials.gov identifier: NCT01083979.

Deborah L. Hasenau, RN, MS, Department of Urology, William Beaumont Hospital, 3535 W. 13 Mile Road Suite 432, Royal Oak, MI 48073, USA. Tel: +248-551-1225; Fax: +248-551-5378. Email: dhasenau@beaumont.edu

Abstract

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.

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