MP38-06 TRANSURETHRAL RADIOFREQUENCY COLLAGEN DENATURATION IN THE TREATMENT OF MILD TO MODERATE FEMALE STRESS URINARY INCONTINENCE: TWELVE-MONTH INTERIM ANALYSIS

Abstract

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence Therapy II1 Apr 2014MP38-06 TRANSURETHRAL RADIOFREQUENCY COLLAGEN DENATURATION IN THE TREATMENT OF MILD TO MODERATE FEMALE STRESS URINARY INCONTINENCE: TWELVE-MONTH INTERIM ANALYSIS James Lukban, Peter Takacs, Monisha Crisell, Douglas Van Drie, Denise Elser, Phillip Bressman, Royce Adkins, and Randall Kahan James LukbanJames Lukban More articles by this author , Peter TakacsPeter Takacs More articles by this author , Monisha CrisellMonisha Crisell More articles by this author , Douglas Van DrieDouglas Van Drie More articles by this author , Denise ElserDenise Elser More articles by this author , Phillip BressmanPhillip Bressman More articles by this author , Royce AdkinsRoyce Adkins More articles by this author , and Randall KahanRandall Kahan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1263AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Women with anatomic stress urinary incontinence may also have a measure of bladder neck funneling, with ultrasound confirmation of its presence found to be associated with a lower maximal urethral closure pressure, a smaller area under the urethral pressure profile curve, a lower leak point pressure, and a larger volume of leakage on pad testing. Radiofrequency (RF) collagen denaturation has been found to reduce tissue compliance, with a potential role in reducing bladder neck funneling in patients with stress urinary incontinence (SUI). We sought to determine the efficacy of RF employing the Lyrette device (Verathon Inc., Bothell, Washington, USA) in women with mild to moderate SUI. METHODS This is an on-going, prospective, 36-month, open-label, multi-center clinical study enrolling women with anatomic SUI and urodynamic indices of Valsalva Leak-point Pressure (VLPP) > or = 90 cm H2O and Maximum Urethral Closure Pressure (MUCP) > or = 45 cm H2O. Intervention was in the form of transurethral RF energy delivered to the bladder neck and proximal urethra at 65 degrees C° to a total of 36 foci. Primary endpoint was the percentage of patients deemed to be “dry” at 12 months as defined by < or = 1 leak on 3-day diary or < or = 1 gram of leak on 1-hour pad weight test (PWT). Secondary endpoints included the proportion of patients with a > or = 50% decrease on PWT; cough stress test (CST); quality of life (QoL) measures including the Incontinence Quality of Life (I-QoL) Questionnaire and the Urogenital distress Inventory (UDI-6); immediate post-treatment pain as per a ten-point Visual Analog Scale (VAS) (1 minimum –10 maximum); and patient satisfaction. RESULTS Fifty-two patients underwent treatment and had follow-up through 12 months. Subjects were analyzed by Intent-to-Treat. Dry rate was 82%; 73% had a > or = 50% decrease on PWT; and 71% exhibited a negative CST. Seventy-nine percent and 80% showed an improvement in I-QoL and UDI-6 scores, respectively. Statistically significant improvement was seen in both QoL scales as compared to baseline. No significant post-treatment pain was recorded, with a mean VAS score of 1.7 + 1.8. Seventy-four percent were “very” or “somewhat”satisfied and 88% would “…refer this treatment to a friend…”. No serious adverse events were recorded. CONCLUSIONS At 12 months, treatment of women with mild to moderate SUI employing Lyrette yielded favorable efficacy, improvement in QoL and high patient satisfaction. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e402-e403 Advertisement Copyright & Permissions© 2014MetricsAuthor Information James Lukban More articles by this author Peter Takacs More articles by this author Monisha Crisell More articles by this author Douglas Van Drie More articles by this author Denise Elser More articles by this author Phillip Bressman More articles by this author Royce Adkins More articles by this author Randall Kahan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...