Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
Interstitial cystitis/painful bladder syndrome (IC/PBS) is a poorly understood chronic disorder of unknown etiology consisting of irritative bladder symptoms and pelvic pain that dramatically affects quality of life.
Liposomes (LP), the treatment article in this proposal, were discovered in the process of exploring a "control" compound when measuring the efficacy of liposomally encapsulated capsaicin for the intravesical treatment of interstitial cystitis. Liposomes are lipid vesicles composed of concentric phospholipid bilayers, which enclose an aqueous interior. Liposomes have the ability to form a molecular film on cell and tissue surfaces and are currently being tested as possible therapeutic agents to promote wound healing. Application of liposomes at the wound surface provides a moist protective film over the wound and augments wound healing without chronic inflammatory reactions in the neodermal layer. Preclinical study data (obtained by using an IC/PBS model in Sprague-Dawley female rats) have demonstrated normalization of urinary frequency indicating that LP may be a potent protectant of the bladder mucosa against inflammation and irritation. Intravesical LP has so far demonstrated an excellent safety profile and minimal toxicity at concentrations of 2 mg/ml. Thus, we hypothesize that intravesical instillation of LP may form a molecular film on bladder ulcer surfaces in patients with IC and provide a safe, effective, and minimally invasive treatment option to alleviating symptoms.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)|
- The primary objective is to determine the impact of 4 bladder instillations of liposomes on symptoms in subjects with IC/PBS. [ Designated as safety issue: No ]The primary endpoint will be changes in symptom severity from baseline to the end of visits 5 and 8 as measured by the O'Leary-Sant IC Symptom and Problem Indices.
- The secondary objective is to determine the safety and tolerability of liposomes instilled into the bladder in subjects with IC/PBS. [ Designated as safety issue: Yes ]
Secondary endpoints will include:
- Changes in Global Response Assessment (GRA)
- Assessment of adverse events
- Changes in urinary frequency, urgency, and pelvic pain as recorded on voiding diaries at baseline and at visits 5 and 8
- Cystoscopic changes in bladder inflammation/ulcers
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731470
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kenneth M Peters, MD||William Beaumont Hospitals|