FIRST RANDOMIZED CONTROLLED TRIAL EVALUATING HYDRODISTENTION TECHNIQUE FOR IC/BPS

INTRODUCTION AND OBJECTIVES: Interstitial cystitis/ bladder pain syndrome (IC/BPS) is a highly morbid and prevalent disease, accounting for 8% of all outpatient urology visits. A well‐recognized treatment for IC/BPS is hydrodistention, yet the optimal hydrodistention technique is unknown. We performed a prospective randomized control trial to determine optimal hydrodistention technique. METHODS: We enrolled patients recommended to undergo hydrodistention. Patients then completed surveys to assess baseline IC/BPS symptoms. Patients underwent hydrodistention and were randomized intraoperatively via factorial design; receiving hydrodistention for (1) 30 or 80cm of pressure for (2) 1 or 2 minutes and (3) 1 or 2 cycles of distention. ICSI was assessed at 1‐week, 4‐weeks, and 12‐weeks postoperatively. Primary endpoint was if hydrodistention technique led to differences in IC Symptom Index (ICSI) surveys from baseline to 4‐ weeks postoperatively. Secondary endpoints were the effects of hydrodistention technique on: 1‐week and 12‐week postoperative changes in ICSI versus baseline, overall urinary symptoms, percentage of patients who reported moderate/marked response to the procedure, and differences in adverse events (AEs). 96 patients had 83% power to detect a 4‐point difference on ICSI for 3 dichotomous factors with 2‐ sided 5% type I error. 1‐way ANOVA models used ICSI difference as the outcome and hydrodistension factor as the independent variable (NCT05456308). RESULTS: After IRB approval, 104 patients were enrolled and 97 (93.3%) completed the postoperative ICSI questionnaires. Median age was 44 years, 96% were Caucasian and 96% were female. 75% of patients had previously undergone hydrodistention. Hydrodistention technique did not lead to a significant difference in ICSI results at 1‐ week, 4‐weeks, or 12‐weeks postoperatively as compared to baseline. (Fig 1) Patients randomized to 2x distentions reported improved urinary symptoms at 12‐weeks postoperatively vs. baseline, as compared to those randomized to 1x distention. Those randomized to 2x distentions had a higher percentage of patients reporting moderate/marked improvement in symptoms at 12‐weeks vs. baseline, as compared to those randomized to 1x distention. There was no difference in adverse events by hydrodistention technique. CONCLUSIONS: We present the first randomized control trial evaluating optimal hydrodistention technique in patients with IC/BPS. Hydrodistention technique did not significantly impact ICSI scores at all time points. Patients undergoing 2x distentions may have improved symptoms at 12‐weeks as compared to those undergoing 1x distention. Higher pressure, longer duration hydrodistentions should be avoided, which expose patients to the risks of bladder injury and longer operative times, without improvement in symptoms.