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A single-dose of URO-902 may prove to be an effective treatment strategy for women with overactive bladder and urge urinary incontinence, according to findings from the final analysis of a phase IIa trial presented at the American Urological Association annual meeting.

In this video, Melissa A. Laudano, MD, of the Montefiore Medical Center and Albert Einstein College of Medicine in the New York City, discusses the design and results from the trial.

Following is a transcript of her remarks:

This is a gene therapy that uses a plasmid vector expressing the large conductance calcium-activated potassium channel alpha subunit.

This study was a 48-week multicenter double-blind placebo-controlled dose-escalation trial. Eighty women were randomized to URO-902, either 24 or 48 mg, or placebo, all administered by intradetrusor injection via cystoscopy.

Both URO-902 24 mg and 48 mg were associated with reductions in daily micturition, urgency episodes, and urge urinary incontinence episodes. This was durable through week 48.

Adverse events occurred in 45.5% of patients in the URO-902 24 mg group, 53.8% in the URO-902 48 mg group, and similarly 53.8% of placebo patients. These were mostly urinary tract infection and hematuria. One patient in the URO-902 48 mg group had asymptomatic elevated post-void residuals that resolved spontaneously.

Of note, efficacy data were somewhat limited due to usage of additional overactive bladder treatments after week 24. We look forward to hearing more about this novel therapy going forward.

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