Short-term Outcomes of Hydrodistention with Intravesical Hyaluronic Acid (Cystistat®) Versus Hydrodistention Alone for Treating Interstitial Cystitis: A Randomized Controlled Trial

Abstract

Background: Interstitial cystitis (IC) is a chronic, debilitating bladder disease that primarily affects middle-aged women and significantly affects their quality of life. Bladder hydrodistention is the usual therapeutic and diagnostic procedure, but symptoms tend to relapse. Adding hyaluronic acid to hydrodistention has been shown to improve the outcomes. Objectives: To compare the therapeutic effects of bladder hydrodistention alone or with intravesical cystistat (40 mg of sodium hyaluronate in a 50 mL vial) in treating IC/bladder pain syndrome (IC/BPS). Methods: This randomized controlled clinical trial was conducted in Imam Reza Hospital of Mashhad in 2017. Twenty-four female IC/BPS patients were selected using clinical examinations and the O`Leary-Sant IC questionnaire to evaluate treatment effects. Patients with a history of other diseases related to the urogenital system and urination frequency less than eight times a day were excluded. The control group (n = 12) underwent hydrodistention under general anesthesia, and the intervention group (n = 12) received intravesical cystistat in addition to hydrodistention weekly for four weeks, followed by monthly for two months. Results: In the control group, the mean baseline score of the questionnaire was 33.2 ± 1.9 and reached 33.9 ± 2.6 after three months, showing no significant change. In the intervention group, the mean baseline score of the questionnaire was 32.6 ± 3.6 and reached 6.4 ± 12.4 at the end of the third month, which indicates a significantly better improvement (P < 0.001). In this study, the disease symptoms resolved in 83.3% of the intervention group after three months of treatment, while the controls did not improve. Conclusions: Based on our study, intravesical instillation of cystistat is effective in treating patients with IC/BPS and has significantly better effects than hydrodistention alone.