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.
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:||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. [ Time Frame: 5 weeks ] [ 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. [ Time Frame: 5 weeks ] [ 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)|
Intravesical instillation of liposomes.
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|