Abstract | AIMS: METHODS: In this phase 3 study, 626 patients ≥18 years old with urgency and/or mixed UI symptoms and predominantly urgency UI for ≥3 months were randomized 1:1:1 to receive 12 weeks of OTG3% 84 mg, OTG3% 56 mg, or placebo gel applied once daily to abdomen, inner/upper thigh, or upper arm/shoulder. Primary efficacy endpoint was change from baseline to Week 12 in weekly UI episodes recorded in 3-day bladder diaries. Results were compared using analysis of covariance. Adverse events (AEs) were monitored. RESULTS: Efficacy was assessed in 601 (intent-to-treat) and safety in 626 patients. At 12 weeks, OTG3% 84 mg/day achieved significantly greater improvement versus placebo in weekly UI episodes (mean change from baseline: -20.4 vs. -18.1; P < 0.05(a)), daily urinary frequency (-2.6 vs. -1.9; P = 0.001(b)), and urinary void volume (32.7 vs. 9.8; P < 0.0001(b)). Dry mouth, the most common treatment-related AE, occurred more often with OTG3% 84 mg/day (26/214 [12.1%]) vs. placebo (10/202 [5.0%]) (P = 0.028); 4 OTG3% patients withdrew because of dry mouth. Application site erythema occurred more often with OTG3% 84 mg/day (8/214 [3.7%]) versus placebo (2/202 [1.0%]) (P = NS); 12 OTG patients withdrew because of skin irritation. No serious treatment-related AEs occurred. CONCLUSIONS:
|
Authors | Evan R Goldfischer, Peter K Sand, Heather Thomas, Jill Peters-Gee |
Journal | Neurourology and urodynamics
(Neurourol Urodyn)
Vol. 34
Issue 1
Pg. 37-43
(Jan 2015)
ISSN: 1520-6777 [Electronic] United States |
PMID | 24133005
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Copyright | © 2013 Wiley Periodicals, Inc. |
Chemical References |
- Gels
- Mandelic Acids
- Urological Agents
- oxybutynin
|
Topics |
- Administration, Cutaneous
- Adult
- Aged
- Aged, 80 and over
- Double-Blind Method
- Female
- Gels
- Humans
- Male
- Mandelic Acids
(administration & dosage, adverse effects, therapeutic use)
- Middle Aged
- Quality of Life
- Treatment Outcome
- Urinary Incontinence
(drug therapy)
- Urological Agents
(administration & dosage, adverse effects, therapeutic use)
- Young Adult
|