PURPOSE: To evaluate the efficacy and safety of once-monthly oxybutynin vaginal ring (Oxy VR) in women with overactive bladder (OAB).
MATERIALS AND METHODS:This randomized, multicenter, double-blind, 12-week Phase 2 study compared Oxy VR (4 or 6 mg/day) to a placebo VR in women with well-defined OAB symptoms. The primary efficacy variable was the change from baseline to Week 12 in the total weekly number of incontinence episodes (stress+urge). Safety was measured in terms of treatment-emergent adverse events, laboratory, physical, gynecological exams, ECG, and vital signs.
RESULTS: Following a 3-week post-randomization placebo run-in-phase (n=720), 445 women entered the treatment-phase (safety population). Of these, 323 met all three OAB-specific baseline characteristics: ≥10 urinary urge incontinence (UUI) episodes/week, urinary frequency ≥8 episodes/week, and void volume ≤ 3 L/24 hours) (analysis population). Women treated with 4 and 6 mg/day Oxy VR had significantly fewer incontinence episodes/week (P=0.36 and P=0.18, respectively), less daily urinary frequency (P=0.014; P=0.002), and a higher proportion had no incontinence episodes at Week 12 (P=0.026; P=0.027) compared with placebo. The change in severity of urgency and void volume was similar for all groups (P>0.05). Except for a higher incidence of dry mouth and urinary tract infections that were not always culture-confirmed, Oxy VR was well-tolerated and had a safety profile similar to that of the placebo VR.
CONCLUSION: Oxy VR appears to be an effective and safe once-monthly treatment option for women with OAB characterized primarily by urinary urge incontinence that merits further evaluation in a Phase 3 study.
Written by:
Gittelman M, Weiss H, Seidman L. Are you the author?
South Florida Medical Research, Aventura, Florida.
Reference: J Urol. 2013 Nov 11. pii: S0022-5347(13)05913-2.
doi: 10.1016/j.juro.2013.11.019
PubMed Abstract
PMID: 24231837
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