PMID- 25209396
OWN - NLM
STAT- MEDLINE
DCOM- 20150720
LR  - 20211021
IS  - 1573-2584 (Electronic)
IS  - 0301-1623 (Print)
IS  - 0301-1623 (Linking)
VI  - 46
IP  - 12
DP  - 2014 Dec
TI  - Liposomal bladder instillations for IC/BPS: an open-label clinical evaluation.
PG  - 2291-5
LID - 10.1007/s11255-014-0828-5 [doi]
AB  - 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.
FAU - Peters, Kenneth M
AU  - Peters KM
AD  - Department of Urology, Beaumont Health System, 3535 W. 13 Mile Road Suite 438, 
      Royal Oak, MI, 48073, USA.
FAU - Hasenau, Deborah
AU  - Hasenau D
FAU - Killinger, Kim A
AU  - Killinger KA
FAU - Chancellor, Michael B
AU  - Chancellor MB
FAU - Anthony, Michele
AU  - Anthony M
FAU - Kaufman, Jonathan
AU  - Kaufman J
LA  - eng
SI  - ClinicalTrials.gov/NCT01731470
GR  - R42 DK085733/DK/NIDDK NIH HHS/United States
GR  - DK085733/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20140911
PL  - Netherlands
TA  - Int Urol Nephrol
JT  - International urology and nephrology
JID - 0262521
RN  - 0 (Liposomes)
RN  - 0 (Sphingomyelins)
SB  - IM
MH  - Administration, Intravesical
MH  - Adult
MH  - Aged
MH  - Cystitis, Interstitial/*drug therapy
MH  - Female
MH  - Humans
MH  - Liposomes/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Pain Management
MH  - Pain Measurement
MH  - Sphingomyelins/*administration & dosage
MH  - Treatment Outcome
PMC - PMC4406402
MID - NIHMS675755
EDAT- 2014/09/12 06:00
MHDA- 2015/07/21 06:00
PMCR- 2015/04/22
CRDT- 2014/09/12 06:00
PHST- 2014/07/17 00:00 [received]
PHST- 2014/08/24 00:00 [accepted]
PHST- 2014/09/12 06:00 [entrez]
PHST- 2014/09/12 06:00 [pubmed]
PHST- 2015/07/21 06:00 [medline]
PHST- 2015/04/22 00:00 [pmc-release]
AID - 10.1007/s11255-014-0828-5 [doi]
PST - ppublish
SO  - Int Urol Nephrol. 2014 Dec;46(12):2291-5. doi: 10.1007/s11255-014-0828-5. Epub 
      2014 Sep 11.