ge; 4 incontinence episodes in a 3-day period and at least 8 micturitions per day. Patients were randomized to daily applications of GELNIQUE 1 gram or matching placebo gel. A total of 389 patients received GELNIQUE and 400 patients received placebo gel. The majority of patients were Caucasian (86.3%) and female (89.2%), with a mean age of 59.4 years (range: 18 to 88 years). The average duration of urinary incontinence was approximately 8.5 years and approximately 75% of patients had no prior pharmacological treatment for urinary incontinence.
Patients treated with GELNIQUE experienced a statistically significant decrease in the number of urinary incontinence episodes per day from baseline to endpoint compared with placebo (p < 0.0001) as well as a decrease in the average daily urinary frequency (p = 0.0017) and an increase in the average urine volume per void (p = 0.0018).
Mean and median change from baseline in daily incontinence episodes (primary endpoint), urinary frequency, and urinary void volume (secondary endpoints) between placebo and GELNIQUE are summarized in Table 3.
Table 3: Mean and median change from baseline for incontinence episodes, urinary frequency, and urinary void volume at Week 12 (LOCF*). Parameter GELNIQUE 1 gram
(N = 389) Placebo
(N = 400)
Mean (SD) Median Mean (SD) Median
*Last-Observation-Carried-Forward statistical imputation for missing data
Daily Incontinence Episodes
Baseline 5.4 (3.26) 4.7 5.4 (3.28) 4.7
Change from baseline -3.0 (2.73) -2.7 -2.5 (3.06) -2.0
Mean difference [GELNIQUE – placebo]
(95% CI) -0.5 (-0.14, -0.87)
P-value vs. placebo < 0.0001
Daily Urinary Frequency
Baseline 12.4 (3.34) 11.7 12.2 (3.32) 11.3
Change from baseline -2.7 (3.21) -2.7 -2.0 (2.82) -1.7
P-value vs. placebo 0.0017
Urinary Void Volume (mL)
Baseline 163.4 (65.85) 160.1 167.9 (68.40) 160.6
Change from Baseline 21.0 (65.33) 11.5 3.8 (53.79) 0.0
P-value vs. placebo 0.0018
16 HOW SUPPLIED/STORAGE AND HANDLING
Metered-Dose Pump: Metered-dose pump dispenser capable of delivering 30 metered 1 gram doses.
Carton of 1 metered-dose Pump (NDC 52544-078-54)
Unit Dose: Heat-sealed sachet containing 1 gram (1.14 mL) of GELNIQUE gel for topical use.
Carton of 30 Sachets (NDC 52544-084-30)
Storage
Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Protect from moisture and humidity. Apply immediately after the sachets are opened and contents expelled or dose delivered from dispenser. Discard used sachets and empty dispensers in household trash in a manner that pre
