CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Liposomesbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01731470
NCT01731470N/ACompleted

Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)

Kenneth Peters, MD·interventional·Posted Nov 21, 2012·Updated Jan 10, 2017

In Brief

A clinical study evaluating Liposomes for Interstitial Cystitis and Pelvic Pain. Completed, enrolled 14 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 21, 2012
Enrollment StartJul 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.6 years ago

Interventions

Liposomesbiological

Intravesical instillation of liposomes.