Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
|ClinicalTrials.gov Identifier: NCT01731470|
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : January 10, 2017
Last Update Posted : January 10, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis Pelvic Pain||Biological: Liposomes||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Intravesical instillation of liposomes.
- Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score [ Time Frame: 4 and 8 weeks post-treatment ]The O'Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.
- Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS) [ Time Frame: 4 and 8 weeks post-treatment ]Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731470
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kenneth M Peters, MD||William Beaumont Hospitals|