Pelvic Pain Clinical Trial
Official title:
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.
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. ;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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