Comparison of the Therapeutic Effects of Hydrodistention Alone or with Intravesical Cystistat for the Treatment of Bladder Pain Syndrome / Interstitial Cystitis

Background and Objective: Interstitial cystitis (IC)/bladder pain syndrome (BPS) is a chronic bladder disease. Hydrodistention of the bladder is used for diagnosis of the disease and also often is the first therapy, but it has a poor long-term prognosis. It is believed that disrupted glycosaminoglycans function may be responsible for IC/BPS symptoms, therefore using exogenous glycosaminoglycans may be beneficial. To test this hypothesis, we compared the therapeutic effects of bladder hydrodistention alone or together with intravesical cystistat (40mg of sodium hyaluronate in a 50ml vial) in the treatment of IC/BPS. Materials and Methods: This randomized controlled clinical trial study was conducted in Urology Clinic of 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, which was also used for evaluating the effects of the treatment. Subscales of the questionnaire include urgency, frequency, nocturia, and dysuria. Patients with a history of other diseases related to the urogenital system, cyclophosphamide use, abdomen or pelvis radiotherapy, and urination frequency less than 8 times a day were excluded from the study. The sample size was calculated 10 for each group. The patients were allocated to the case (n=12) and control (n=12) groups based on the randomized computer assignment list. The control group underwent hydrodistention under general anesthesia and intervention group received intravesical instillation of cystistat in addition to the hydrodistention; weekly for four weeks, then monthly until two months later. The data were analyzed using SPSS version 16. All patients signed consent forms. The study was approved by Iran s north-east ethics committee; registration number: 950419. Findings: Mean age of intervention group was 46 ± 9 years, which was not significantly different from the control group (p-value = 0.71). Also, the two groups were similar in terms of gravidity and parity of patients. In the control group the mean score of the questionnaire at the baseline was 33.2 ± 1.9, and reached 33.9 ± 2.6 after three months, showing no significant change, but in the intervention group the mean score of the questionnaire was 32.6 ± 3.6 at the baseline and reached 6.4 ± 12.4 at the end of the third month, which indicates significantly better improvements (p <0.001). In this study, 83.3 % of intervention group lost the symptoms of the disease after three months of treatment, while the controls did not show any improvements. Conclusion: Based on our study, intravesical instillation of cystistat is effective in the treatment of patients with IC/BPS and has significantly better effects compared to hydrodistention alone.

Keywords:

Bladder Pain Syndrome , Interstitial Cystitis , Cystistat , hyaluronic acid , hydrodistention