THREE-MONTH EFFICACY ANDTWELVE-MONTH TREATMENT ARM RESULTS FROM THE SUCCESS STUDY OF ANINTRAVESICAL BALLOON TO TREAT FEMALE STRESS URINARY INCONTINENCE(SUI)
H. WINKLER1, K.JACOBY 2, S. KALOTA 3, J. SNYDER 4,K. CLINE 5, K. ROBERTSON 6, C. R. RARDIN 7,R. KAHAN 8, L. GREEN 9, S. A. MALIK 10,K. MCCAMMON 11, E. ROVNER 12;
1NorthShore-LIJ, Great Neck, NY, 2Integrity Med. Res., MountlakeTerrace, MA, 3Urological Associates of Southern Arizona,Tuscon, AZ, 4Genitourinary Surgical Consultants, Denver,CO, 5Regional Urology Associates, Shreveport, LA,6Chesapeake Urology Associates, Glen Burnie, MD, 7AlpertMed. Sch. of Brown Univ., Providence, RI, 8WomanCare,Arlington Heights, CA, 9Virginia Women's Ctr., Richmond,VA, 10Banner Good Samaritan Hosp., Phoenix, AZ, 11EasternVirginia Med. Sch., Virginia Beach, VA, 12Med. Univ. ofSouth Carolina, Charleston, SC.
Introduction: This abstractdescribes a novel technique for treating SUI that focuses on thereduction in transient spikes in intravesical pressure by insertionof a free-floating, non-occlusive intravesical balloon filled withcompressible gas. Since gas is highly compressible relative to mostliquids, it can act as a hydraulic “shock-absorber.”1This fundamental mechanism of action in an intravesical applicationhas been described in previous published studies2including a previous prospective, randomized, single blind,multicenter study on a different patient population.3
Objective:The SUCCESS trial is a phase III study of the Vesair® balloon in theUnited States for SUI. The purpose of this abstract is to evaluatethe three-month primary efficacy and tolerability outcome data andtwelve-month results from subjects in the treatment arm.
Methods:The SUCCESS trial is a multi-center, prospective, single blind,randomized, sham-controlled study. Subjects were randomized on a2.33:1 basis to either Vesair balloon placement or placebo. Theprimary efficacy endpoint was a composite of both a >50% reductionfrom baseline on 1-hour provocative pad weight test and a ≥10-pointimprovement in symptoms on the Incontinence Quality of Life Survey(I-QOL) questionnaire assessed at the three-month study visit. Thedeflated 30cc polyurethane balloon is pre-inserted inside the tip ofa 19 French (F) delivery system and inserted into the bladder througha sheath, inflated and released. The balloon is removed under directvisualization using a custom optical grasper through a sheath. Shamballoon insertion procedures for subjects in the control arm wereidentical with the exception of actual balloon deployment.
Results:A total of 221 subjects were randomized, including 157 treatment armsubjects and 64 controls. The three-month composite primary efficacyendpoint was achieved in 42.1% of treatment group subjects comparedwith 28.1% of controls on intention-to-treat (ITT) analysis(p=0.046). Treatment arm subjects were significantly more likely toreport at least a 50% reduction in incontinence frequency on 7-dayvoiding diary (53.7% vs. 32.7%, p=0.004, ITT) and more commonlyreported their incontinence was improved on Patient Global Impressionof Improvement in Incontinence (PGI-I) at three months compared withcontrols (58.1% vs 37.7%, p=0.006, ITT). Evaluable results wereobtained from 67 subjects in the treatment arm who remained in thestudy beyond six months (12-month cohort). At three months, 55.2% ofthe subjects in the 12-month cohort met the composite endpoint and56.3% met the endpoint at 12 months. The percentage of subjects witha greater than 50% reduction in their provocative pad weightincreased from 67.7% at three months to 78.7% at 12 months.Furthermore, 44.6% of subjects were “dry” on their provocativepad weight test (dry is defined as ≤ 2 g post-test pad weight) atthree months compared to 59% at 12 months. An improvement in symptomswas reported on the subject’s PGI-I questionnaire, with 65.7% ofsubjects in the 12-month cohort reporting improvement at threemonths, and 71.6% at 12 months. Mean reduction in absorbent pad usagewas 1.3 pads/day at 3 months and 1.1 pads/day at 12 months. Nodevice- or procedure-related serious adverse events nor unanticipatedadverse events were reported and no cases of urinary retention wereobserved. All adverse events fully resolved following balloonremoval.
Conclusions: In this phase three trial, the Vesairintravesical balloon demonstrated 3-month success at primary andsecondary endpoints both objectively and subjectively. For thosepatients in the treatment arm that continued to 12 months, objectiveand subjective improvements continued.
References: 1 FluidTransients in Systems. 1993. Prentice Hall Publishers, EnglewoodCliffs, NY, USA. p125. 2 Neurourology Urodyn. 2009;28(7):781-783.3 J Urol 2013; 190; 2243-50.