Interstitial cystitis/painful bladder syndrome (IC/PBS) is a chronic bladder condition characterized by frequent urination, bladder inflammation and pain. It is a particular challenging disease and a clear unmet medical need in terms of identifying new therapeutic strategies. The aim of study was to evaluate the anti-inflammatory effects of intravesical Vessilen® (a new formulation of 2% adelmidrol (the diethanolamide derivative of azelaic acid) + 0.1% sodium hyaluronate) administration in rodent models of IC/BPS and in IC/BPS patients or other bladder disorders. Acute and chronic animal models of cystitis were induced by a single or repetitive intraperitoneal injections of cyclophosphamide (CYP); patients with IC/BPS or with bladder pain syndrome associated with symptoms of the lower urinary tract treated once weekly by bladder instillation of Vessilen® for 8 weeks. CYP instillation caused macroscopic and histological bladder alterations, inflammatory infiltrates, increased mast cell numbers, bladder pain, increased expression of nitrotyrosine, decreased expression of endothelial tight junction zonula occludens-1. Intravesical Vessilen® treatment was able to ameliorate CYP induced bladder inflammation and pain by inhibiting nuclear factor-κB pathway and inflammatory mediator levels as well as reduced mechanical allodynia and nerve growth factor levels. A significant improvement in quality of life and symptom intensity were evident in patients with IC/BPS or other bladder disorders treated with Vessilen®. Vessilen® could be a new therapeutic approach for human cystitis.
Pharmacological research. 2018 May 22 [Epub ahead of print]
Edoardo Ostardo, Daniela Impellizzeri, Mauro Cervigni, Daniele Porru, Monica Sommariva, Marika Cordaro, Rosalba Siracusa, Roberta Fusco, Enrico Gugliandolo, Rosalia Crupi, Carlo Schievano, Antonino Inferrera, Rosanna Di Paola, Salvatore Cuzzocrea, Urology Study Group
Urodynamic and Neurourology Unit, S Maria degli Angeli Hospital, Pordenone, Italy. Electronic address: ., Department of Chemical Biological, Pharmaceutical and Environmental Sciences, University of Messina, Viale Ferdinando Stagno D'Alcontres 31, 98166, Messina, Italy. Electronic address: ., Interstitial Cystitis Referral Center, Department of Women's Health and New Life, Catholic University, Rome, Italy. Electronic address: ., Department of Urology, Fondazione IRCCS Policlinico S.Matteo, Pavia, Italy. Electronic address: ., Division of Urology - "G.Fornaroli" Hospital, Magenta, MI, Italy. Electronic address: ., Department of Chemical Biological, Pharmaceutical and Environmental Sciences, University of Messina, Viale Ferdinando Stagno D'Alcontres 31, 98166, Messina, Italy. Electronic address: ., Department of Chemical Biological, Pharmaceutical and Environmental Sciences, University of Messina, Viale Ferdinando Stagno D'Alcontres 31, 98166, Messina, Italy. Electronic address: ., Department of Chemical Biological, Pharmaceutical and Environmental Sciences, University of Messina, Viale Ferdinando Stagno D'Alcontres 31, 98166, Messina, Italy. Electronic address: ., Department of Chemical Biological, Pharmaceutical and Environmental Sciences, University of Messina, Viale Ferdinando Stagno D'Alcontres 31, 98166, Messina, Italy. Electronic address: ., Department of Chemical Biological, Pharmaceutical and Environmental Sciences, University of Messina, Viale Ferdinando Stagno D'Alcontres 31, 98166, Messina, Italy. Electronic address: ., Innovative Statistical Research, Padua, Italy. Electronic address: ., Department of General Surgery, Oncology and Pathology, Urology Unit, University of Messina, Via Consolare Valeria 1, 98100, Messina, Italy. Electronic address: ., Department of Chemical Biological, Pharmaceutical and Environmental Sciences, University of Messina, Viale Ferdinando Stagno D'Alcontres 31, 98166, Messina, Italy. Electronic address: ., Department of Chemical Biological, Pharmaceutical and Environmental Sciences, University of Messina, Viale Ferdinando Stagno D'Alcontres 31, 98166, Messina, Italy; Manchester Biomedical Research Centre, Manchester Royal Infirmary, School of Medicine, University of Manchester, Manchester, United Kingdom. Electronic address: .