Preface
As the world's largest and most influential urology academic conference, the annual meeting of the American Urological Association (AUA) was held in San Antonio, USA from May 3 to 6 local time. The plenary session specially set up a Practice-changing, Paradigm-shifting (P2s) summary report session, in which the clinical studies that are about to break the pattern of clinical practice and bring breakthrough impact are displayed in a unified manner, which has attracted much attention! Professor Alexander Zhu of the University of Michigan brings a prospective randomized controlled trial that first evaluates the best operation plan for bladder water dilation, let's take a look!
Background:
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a serious and common urological condition, accounting for 8% of all urology outpatient visits due to IC/BPS. Bladder water dilatation has been accepted in the IC/BPS evaluation and treatment area, however clinicians perform bladder water dilatation with wide variation, and the optimal pressure values, duration, and frequency are unknown. Therefore, our research team conducted a prospective randomized controlled trial to determine the optimal protocol for hydrodilation.
Research Methods:
This study is a single-center, single-disease, single-blind randomized controlled trial that enrolled patients with IC/BPS who were expected to undergo hydrodilation. Patients first filled out the Symptom Index Score (ICSI) questionnaire to assess baseline disease characteristics, and then were randomized during the procedure according to the factorial design to receive (1) normal saline pressure values: 30 or 80 cmH2O, respectively; (2) Expansion time: 1 or 2 min; (3) Expansion cycle: 1 or 2 times. ICSI changes were assessed at 1, 4 and 12 weeks postoperatively. The primary endpoint was whether hydrodilation resulted in an improvement in ICSI scores from baseline to four weeks postoperatively. Secondary endpoints were the effect of hydrodilation on change in ICSI score from baseline at 1 and 12 weeks postoperatively, global urinary tract symptoms, proportion of patients with moderate/significant symptom improvement, and adverse events (AEs).
Findings:
A total of 104 patients were enrolled with the approval of the Institutional Review Board (IRB), of which 97 (93.3%) completed the postoperative ICSI questionnaire. The median age of patients was 44 years, 96% Caucasian and 96% female. Seventy-five percent of patients had previously undergone hydrodilation.
There was no significant difference in ICSI scores at 1, 4, and 12 weeks postoperatively in patients who underwent hydrodilation compared to baseline.
However, in terms of overall urinary tract symptoms (patient self-reported), patients who received 2 dilation cycles reported a statistically significant improvement from baseline at 12 weeks postoperatively, and a higher proportion of patients with moderate/significant symptom improvement compared to 1 dilation cycle.
In addition, the safety of hydrodilation was good, and there were no events such as sepsis, urinary retention, and bladder rupture.
Conclusions of the study
Compared with baseline, the ICSI score of patients undergoing hydrodilation was not statistically significant at all time points, but clinical improvement in symptoms within 1 month after surgery was observed. Patients who received 2 dilations may experience significant improvement in overall urinary tract symptoms 12 weeks postoperatively, suggesting that a higher number of dilations may result in longer-lasting symptom relief. In addition, the research team found no evidence that the pressure value (30 or 80 cmH2O) and duration (1 or 2 min) of hydrodilation could affect symptom relief, suggesting that higher pressure and longer hydrodilation should be avoided in the future, as this increases the risk of bladder injury and longer operation time, but does not lead to better symptom improvement.
Bibliography:
[1]https://www.auajournals.org/doi/10.1097/01.JU.0001015816.87470.c9.14
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