A Pilot Open Label Study of Cystoprotek® in Interstitial Cystitis

Abstract

Interstitial cystitis (IC) is a disorder of the urinary bladder characterized by urgency, frequency, nocturia and suprapubic pain. IC occurs primarily in women and symptoms are exacerbated by stress, ovulatory hormones and certain foods. IC pathogenesis is unknown, but the most consistent findings involve some dysfunction of the bladder glycosaminoglycan (GAG) protective layer and a high number of activated bladder mast cells. There is no effective therapy even through intravesical administration of dimethylsulfoxide (DMSO) or oral pentosanpolysulfate (PPS) have had variable success. A dietary supplement, CystoProtek®, was formulated with the natural GAG components chondroitin sulfate and sodium hyaluronate to provide urothelial cytoprotection, together with the flavonoid quercetin that has anti-inflammatory properties and inhibits activation of mast cells. Thirty-seven female patients diagnosed by the NIDDK criteria who had failed all forms of therapy took six softgel CystoProtek® capsules per day for 6 months. Global assessment scale was reduced from 9.0 ± 2.9 to 4.3 ± 2.1 (p <0.05); moreover, the O'Leary/Sant Symptom Index decreased from 16.3 ± 3.1 to 6.9 ± 4.2 (p <0.05) and the Problem Index from 13.1 ± 3.7 to 5.4 ± 4.0 (p <0.05). These results are very promising and warrant a larger study that may permit further analyses with respect to other, especially atopic, comorbid diseases.

Evidence for the Role of Mast Cells in Cystitis-Associated Lower Urinary Tract Dysfunction: A Multidisciplinary Approach to the Study of Chronic Pelvic Pain Research Network Animal Model Study

“…tumor necrosis factor-α and stem cell factor) can activate mast cells to release mediators [2]. Clinical trials in IC/BPS using mast cell inhibitors have been conducted and demonstrated to be promising [4–6]. In line with human studies, animal studies have demonstrated that mast cells are responsible for bladder inflammation and pain in diverse models [7–10].…”

A combined intravesical therapy with hyaluronic acid and chondroitin for refractory painful bladder syndrome/interstitial cystitis

“…Heparin sulfate, hyaluronic acid (HA), and chondroitin sulfate (CS) are all either part of the urothelial barrier or very similar in structure to GAGs. These substances are administered orally [9], intravesically [10][11][12], or both, with the aim of restoring the integrity of the GAG layer. Therapy protocols utilized with these medications vary among different authors, and the optimal mode of treatment has not been established yet.…”

Effect of Supplementation With Hydrogen-rich Water in Patients With Interstitial Cystitis/Painful Bladder Syndrome

“…9,10 Previously, several trials were reported of L-arginine and quercetin that have similar anti-oxidant mechanism. [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25] L-arginine supplementation is used to counteract reduced production of nitric oxide (NO). NO is the oxidation product of L-arginine, a reaction catalyzed by NO synthase (NOS).…”