INTRODUCTION AND OBJECTIVES: The artificial urinary sphincter (AUS) has been the gold standard treatment of male stress urinary incontinence, particularly ...
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development for the treatment of patients with overactive bladder. A phase II multi-center, randomized, double-blind, placebo-controlled, parallel group study was performed to evaluate the safety and efficacy of oral solabegron in women with over active bladder symptoms. METHODS: 258 women were enrolled to receive solabegron 50 mg, 125 mg, or matching placebo twice daily for 8 weeks. Based on a 3-day electronic diary, patients with ⬎ 8 micturitions/24 hr, and ⬎1 incontinence episodes/24 hr and ⬎ 1 urgency episodes/24 hr were randomized to double-blind treatment. Percent change from baseline to 8 weeks in the number of incontinence episodes/24 hr was the primary endpoint. RESULTS: In this patient population the mean baseline for incontinence episodes was 4.5 episodes/24hr. For the primary endpoint, solabegron (125 mg) produced a statistical significant 65% adjusted mean reduction from baseline in incontinence episodes and an adjusted mean difference from placebo of 21% (p⫽0.025). The median reduction in incontinence episodes was 75% from baseline. Solabegron produced an adjusted mean reduction from placebo in incontinence episodes for both the 50 mg (23%; p⫽0.03) and 125 mg (32%; p⫽0.003) treatment groups after 4 weeks of treatment. At the 125 mg dose there was a significant reduction in the number of micturitions at week 4 (⫺0.7; p⫽0.05) and week 8 (⫺0.8; p⫽0.036). There was a marked and significant increase in the volume voided per micturition at week 8 for the solabegron 125mg treatment group (⫹27%; p⬍0.001). The extent of the solabegron response was similar in patients with or without the Trp64Arg polymorphism of the beta-3 adrenoceptor. Solabegron was safe and well-tolerated. There were no significant differences in AEs between placebo and the solabegron treatment groups. The most common AE’s across the placebo and treatment groups were headache (8%, 8%), nasopharingitis (11%, 6%) and dry mouth (4%, 1%), respectively. There were no significant changes in clinical chemistry, hematology or ECG parameters. Urinary retention was not observed. There were no significant treatment differences for mean changes in ambulatory SBP, DBP, MAP or heart rate during 24 hr measurement. CONCLUSIONS: The results of this phase 2 clinical study demonstrate that solabegron is efficacious, safe and well-tolerated in the treatment of patients with OAB. Source of Funding: GlaxoSmithKline Pharmaceuticals
521 PATIENT PERCEPTION OF THE ARTIFICIAL URINARY SPHINCTER DEVICE: WHAT DO MEN WITH AUS ACTUALLY THINK OF THEM? Michelle Koski*, Charleston, SC; Austin Lutz, New Orleans, LA; Benjamin Whittam, Indianapolis, IN; Melissa Kaufman, Nashville, TN; Ryan Krlin, Cleveland, OH; Douglas Milam, Nashville, TN; J. Christian Winters, New Orleans, LA INTRODUCTION AND OBJECTIVES: The artificial urinary sphincter (AUS) has been the gold standard treatment of male stress urinary incontinence, particularly for higher volume leakage. Prior to surgery, there are concerns about the presence and functionality of a foreign device, which may effect treatment decision. We sought to assess patient perception of the AUS, focusing on functionality, comfort, aesthetics, and global satisfaction. Although prior studies have documented high overall patient satisfaction with the device, none have examined this particular question – which is extremely valuable in patient counseling. METHODS: IRB approved study of patients undergoing AUS from 1/2000 to 1/2011 at two academic institutions was performed. A validated instrument developed by the Veterans Administration Prosthetics Research Study (PEQ) to assess patient satisfaction and perception of prosthetic limbs was adapted to AUS appropriate questions. It is annotated on a continuous numerical variable (visual analogue scale) measured from 0 to 100 with higher numbers corresponding to a more positive response. The PEQ is composed of 9 validated scales. Applicable questions were utilized covering 6 of the 9 domains: appear-
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ance, frustration, perceived response, social burden, utility and wellbeing. Questionnaires were mailed to patients agreeing to participate and responses recorded and correlated clinically. RESULTS: 162 patients with AUS were identified, 93 were accessible by telephone and agreed to participate, and 66 returned questionnaires (71% response). 91% were post prostatectomy, and 25.8% had undergone radiation. Regarding subjective urinary status, 50% had reported using no pads or a pad for confidence and 40.7% described themselves as significantly improved, using 1 pad per day (PPD). Reported pad usage decreased from an average of 6.6 to 1.0 PPD. The overall majority of men expressed little to no bother, cosmetic, social, or functional concerns regarding the scrotal pump. Mean scores for each domain were: 81.0 (appearance), 79.5 (frustration), 83.1 (perceived response), 82.2 (social burden), 79.8 (utility) and 81.9 (well being). Non-painful scrotal sensation was reported by 37.9% (81.5 mean bother score, with score of 100 ⫽ extremely mild) and scrotal pain in 33.3% (77.4 mean bother score). CONCLUSIONS: Average scores reflecting sphincter utility and appearance, patient frustration, perceived response, social burden and well being revealed minimal negative impact on quality of life. These findings may be useful in the counseling of patients prior to treatment of male SUI. Source of Funding: None
522 EFFICACY AND SAFETY OF OXYBUTYNIN TOPICAL GEL (84 MG OR 56 MG/DAY) IN PATIENTS WITH URGENCY AND/OR MIXED URINARY INCONTINENCE: RESULTS OF A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY Evan Goldfischer*, Poughkeepsie, NY; Peter Sand, Evanston, IL; Jill Peters-Gee, Farmington, CT INTRODUCTION AND OBJECTIVES: A new oxybutynin gel (OTG) with propylene glycol to aid transdermal delivery is dispensed via a pump, giving the option of dose titration. The efficacy and safety of this OTG (84 mg or 56 mg) vs placebo were assessed in a phase 3 study (NCT00909181; www.clinicaltrials.gov) in adults with overactive bladder syndrome. METHODS: Patients aged ⬎ 18 years with symptoms of urgency and/or mixed urinary incontinence (UI) with a predominance of urgency urinary incontinence for ⬎ 3 months at 63 centers in the United States were enrolled. Patients were randomized 1:1:1 to 12 weeks of OTG 84 mg, OTG 56 mg, or placebo gel applied once daily to the abdomen, inner and upper thighs, or upper arm/shoulder. The primary efficacy variable was change from baseline to study end (week 12) in mean number of daily UI episodes as recorded in a 3-day bladder diary. Analysis of covariance was used to compare efficacy results for OTG and placebo groups. Adverse events (AEs) were monitored throughout the study. RESULTS: A total of 532 randomized patients were included in the efficacy analyses and 626 in the safety analyses. The mean age of patients was 59 years; 542/626 (87%) were white; 542/626 (87%) female. OTG 84 mg and 56 mg treatment resulted in significantly greater improvement compared with placebo in daily UI episodes. OTG groups also had numerically or significantly greater improvement in the secondary outcome variables of daily urinary frequency and urinary voided volume (Table). Dry mouth was the most commonly reported treatment-related AE and occurred more often with OTG 84 mg and 56 mg (26/214 [12.1%] and 23/210 [11.0%], respectively) than with placebo (10/202 [5.0%]); 4 patients in the OTG groups withdrew because of dry mouth. Application site erythema, the next most commonly reported treatment-related AE, occurred more often with OTG 84 mg and 56 mg (8/214 [3.7%] and 8/210 [3.8%], respectively) than with placebo (2/202 [1.0%]).12 patients in the OTG groups withdrew because of skin irritation. No serious treatment-related AEs occurred.
