Gene Therapy With URO-902 (pVAX/ hSlo) for the Treatment of Female Patients With Overactive Bladder and Urge Urinary Incontinence: Safety and Efficacy From a Randomized Phase 2a Trial
Document Type
Article
Publication Date
4-2025
Publication Title
The Journal of urology
Abstract
PURPOSE: We assessed efficacy and safety of URO-902, an investigational gene therapy expressing the α subunit of the large-conductance Ca
MATERIALS AND METHODS: Women, age 40 to 79 years, with OAB and urge urinary incontinence who were refractory to OAB medications were randomized to single-dose URO-902 24 and 48 mg or placebo administered by intradetrusor injection via cystoscopy under local anesthesia. Efficacy end points included change from baseline to week 12 in mean daily micturitions, urgency episodes, urge urinary incontinence episodes, and patient-reported outcomes. Safety assessments included adverse events and postvoid residual urine volume.
RESULTS: Of 80 patients randomized (URO-902 24 mg, n = 26; URO-902 48 mg, n = 27; placebo, n = 27), 74 received treatment, and 67 reached week 24. At week 12, URO-902 24 and 48 mg were associated with significant improvement vs placebo in daily micturitions (least-squares mean change from baseline, -2.3 and -2.4 vs -0.8, respectively; least-squares mean difference [95% CI], ‒1.5 [‒2.7 to ‒0.3] and ‒1.6 [‒2.8 to ‒0.4], nominal
CONCLUSIONS: In this phase 2a trial, treatment with URO-902 was associated with improvements vs placebo in efficacy and patient-reported outcomes and was safe and well tolerated.
Volume
213
Issue
4
First Page
417
Last Page
427
Recommended Citation
Enemchukwu EA, Kalota S, Robertson K, Ge S, Lu J, Badger H, et al [ Peters KM] Gene therapy with URO-902 (pVAX/hSlo) for the treatment of female patients with overactive bladder and urge urinary incontinence: safety and efficacy from a randomized phase 2a trial. J Urol. 2025 Apr;213(4):417-427. doi: 10.1097/JU.0000000000004373. PMID: 39693268.
DOI
10.1097/JU.0000000000004373
ISSN
1527-3792
PubMed ID
39693268
