Bladder Instillation of 2% Adelmidrol + 0.1% Sodium Hyaluronate for the Treatment of Bladder Pain Syndrome/Interstitial Cystitis‐Related Pelvic Pain

Introduction: Bladder pain syndrome (BPS)/interstitial cystitis (IC) is a chronic inflammatory condition characterized by bothersome symptoms as pain, urgency, urinary incontinence and in some cases urinary retention, impacting a patient’s quality of life. However, also recurrent cystitis could cause a chronic bladder inflammation which can explain discomfort of the bladder and similar symptoms, often referred by younger patients during clinical evaluation. The aetiology of IC/BPS is still unknown, and it may be multifactorial. Although a definitive treatment is not available, the challenge is finding new therapeutic strategies. Different intravesical treatments such as heparin, hyaluronic acid, chondroitin sulfate, pentosan polysulfate, dimethylsulfoxide, liposomes, and botulinum onabotulinumtoxinA (BoNT‐A) are commonly proposed for BPS/IC. 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 patients affected by IC/BPS or other bladder disorders. Methods: This was a prospective observational study. At baseline and after the treatment, validated questionnaires were administered to the patients: the Visual Analogue Scale (VAS) and International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ‐FLUTS Long Form). The subjective perception of the severity of symptoms was investigated by the Patient global impression scale (PGIs). Results: Based on 25 patients who completed the cycle of weekly instillation for six weeks, we observed a significant decrease in the severity of bladder symptoms according to both ICIQ‐FLUTS scale (89.3 vs 61.3; p=0.021) and VAS score (4.4 vs 2.6; p<0.001). Moreover, according to PGI‐I, 80% of patients observed an improvement in symptoms (PGI‐I score ≤ 3). Conclusion: Intravesical administration of adelmidrol combined with sodium hyaluronate (Vessilen®) could be an innovative therapeutic approach for patient complaining interstitial cystitis/bladder pain syndrome (IC/BPS) or other chronic inflammatory bladder disorders, due to its well‐known anti‐inflammatory and antinociceptive properties. Introduction: Bladder pain syndrome (BPS)/interstitial cystitis (IC) is a chronic inflammatory condition characterized by bothersome symptoms as pain, urgency, urinary incontinence and in some cases urinary retention, impacting a patient’s quality of life. However, also recurrent cystitis could cause a chronic bladder inflammation which can explain discomfort of the bladder and similar symptoms, often referred by younger patients during clinical evaluation. The aetiology of IC/BPS is still unknown, and it may be multifactorial. Although a definitive treatment is not available, the challenge is finding new therapeutic strategies. Different intravesical treatments such as heparin, hyaluronic acid, chondroitin sulfate, pentosan polysulfate, dimethylsulfoxide, liposomes, and botulinum onabotulinumtoxinA (BoNT‐A) are commonly proposed for BPS/IC. 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 patients affected by IC/BPS or other bladder disorders. Methods: This was a prospective observational study. At baseline and after the treatment, validated questionnaires were administered to the patients: the Visual Analogue Scale (VAS) and International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ‐FLUTS Long Form). The subjective perception of the severity of symptoms was investigated by the Patient global impression scale (PGIs). Results: Based on 25 patients who completed the cycle of weekly instillation for six weeks, we observed a significant decrease in the severity of bladder symptoms according to both ICIQ‐FLUTS scale (89.3 vs 61.3; p=0.021) and VAS score (4.4 vs 2.6; p<0.001). Moreover, according to PGI‐I, 80% of patients observed an improvement in symptoms (PGI‐I score ≤ 3). Conclusion: Intravesical administration of adelmidrol combined with sodium hyaluronate (Vessilen®) could be an innovative therapeutic approach for patient complaining interstitial cystitis/bladder pain syndrome (IC/BPS) or other chronic inflammatory bladder disorders, due to its well‐known anti‐inflammatory and antinociceptive properties.