Isosorbide dinitrate as an effective adjunct therapy for acute urinary retention: A randomized controlled trial
Abstract
Objective: To evaluate the synergistic effect and safety of sublingual isosorbide dinitrate (ISDN) to facilitate successful voiding trial after catheterization for acute urinary retention (AUR) secondary to benign prostatic hyperplasia (BPH).
Material and methods: In this randomized clinical trial, male patients aged ≥ 50 years presenting with first-episode AUR secondary to BPH at our urology emergency department were enrolled during 2019-2020. Participants were randomly assigned to receive either standard therapy (α1-blocker and 5α-reductase inhibitor) alone (n = 40) or in combination with daily sublingual ISDN 10 mg for 21 days (n = 40). Primary outcomes included successful voiding post-catheter removal as trial without catheter (TWOC) and post-void residual (PVR) volume. Secondary outcomes included post-treatment prostate-specific antigen (PSA) levels and adverse events. Data were analysed using independent t-tests and chi-square tests.
Results: A total of 80 men with similar baseline characteristics were enrolled (mean ages: 70.3 ± 7.97 in the ISDN group vs. 68.2 ± 8.73 years in the controls). The rate of successful TWOC was significantly higher in the ISDN plus standard therapy group compared with standard therapy alone (50.0% vs. 22.5%, p = 0.011). PVR volume decreased significantly after treatment in both groups (within-group p p = 0.002). PSA levels remained stable, with no significant within- or between-group differences. On multivariable logistic regression…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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