efficacy and safety of repeated treatment with onabotulinumtoxinA (onabotA) 100U (up to 3.5 years) in patients (pts) with overactive bladder syndrome (OAB). METHODS: Following completion of either of two 24-week, randomized, phase 3 trials, pts were eligible to enter a 3-year extension study in which they could receive multiple intradetrusor onabotA treat- ments. Pts were treated ‘as needed’ based on their request and fulfill- ment of prespecified qualification criteria. Data were assessed for the discrete subpopulations of pts who needed exactly 1 (n¼105), 2 (n¼118), 3 (n¼117), 4 (n¼83), 5 (n¼46), or 6 (n¼33) onabotA (100U) treatments during study participation in order to evaluate consistency of response to repeated treatments. Assessments included mean change in UI episodes/day (co-primary endpoint) at week 12 after treatment, proportion of pts with an overall median time to request retreatment (duration of effect) of 6 months, 6-12 months, and >12 months, and adverse events (AEs). RESULTS: Of the 543 pts who received onabotA 100U, 51.2% completed the study. Discontinuations due to AEs/lack of efficacy were low (5.3/2.8%); the most common reasons for discontinuation were not treatment-related (e.g. personal reasons, study burden, site closure, etc). Baseline mean UI episodes/day were 4.5, 5.0, 5.8, 5.9, 5.2, and 5.7 in the subgroups of pts who needed 1, 2, 3, 4, 5, and 6 onabotA (100U) treatments during the study. Mean reductions in UI episodes/day at week 12 after each treatment were consistent in all subgroups, irrespective of the number of treatments needed; ranges for subgroups who received 1, 2, 3, 4, 5, and 6 treatments were: -3.1; -2.9 to -3.2; -4.1 to -4.5; -3.4 to -3.8; -3.0 to -3.6; and -3.1 to -4.1. As ex- pected, pts who received fewer treatments had longer duration of effect than pts who received more treatments. The median time to request re-treatment was 6 months for 34.2%, 6-12 months for 37.2%, and >12 months for 28.5% of pts; overall median duration of effect was 7.6 months. Urinary tract infection was the most common AE observed, with no changes in safety profile observed over time. CONCLUSIONS: Long-term treatment with onabotA (100U) resulted in consistent reductions in daily UI episodes, with a median duration of effect >6 months in w2/3 of pts and >12 months in almost 1/3 of patients. No increases in AE rates were observed with repeated treatment. Source of Funding: Allergan, Inc. PI-05 IS RETROPUBIC MID-URETHRAL SLING SAFE AND EFFECTIVE FOR PATIENTS WITH VALSALVA VOIDING? Blake Anderson*, Joseph Pariser, Shane Pearce, Gregory Bales, Chicago, IL; Doreen Chung, New York, NY INTRODUCTION AND OBJECTIVES: Due to the potential risk of voiding dysfunction after retropubic sling (RPS), there is concern regarding its use in women who void with Valsalva. The aim of this study was to compare outcomes after RPS in women with and without Valsalva voiding (VV). METHODS: 141 women underwent RPS for stress incon- tinence from 2011-2014. Baseline demographics, urodynamics (UDS), operative and follow-up data were examined. VV was defined as abdominal straining throughout voiding on UDS. Analysis of those with VV included a subset with detrusor underactivity (DU) on UDS who had detrusor pressure <10 cm H2O or <20 sec contraction. Follow-up was at 1, 3, 6 and 12 months. Primary outcomes were subjective success rate (absence of stress incontinence with activity, coughing or sneezing), revi- sion rate and complication (perioperative and 90-day) rate. Sec- ondary measures were Urogenital Distress Inventory (UDI-6) score, Incontinence Impact Questionnaire (IIQ-7) score, post-void residual (PVR) and pad use. Tests of significance were Fisher’s exact and t-tests. RESULTS: Subjects included 75 Valsalva voiders (V) and 66 non-Valsalva voiders (N). At baseline, no differences were seen in age, race, comorbidity, PVR, pad use, UDI-6 or capacity. V had lower IIQ-7 (9.5  6.6 vs. 12.6  6.7, p¼0.01) and more DU (23% vs. 5%, p<0.01) compared to N. No differences were seen in rates of passing initial void trial, clean intermittent catheterization, revisions, complications or voiding dysfunction. Revisions were for pain (1 V, 1 N), erosion (1 V, 4 N), voiding dysfunction (2 V, 3 N), sling migration (1 V) and sling failure (2 V, 1 N). Subjective success was similar out to 12 months (96% V vs. 92% N, p¼0.6). At 6 and 12 months, there were no differences in pad use, UDI-6 or IIQ-7. For patients in V with and without DU, no differences were seen in rates of success, re- visions, complications, voiding dysfunction or changes in UDI-6, IIQ- 7, PVR or pad use. For V with DU, complications were 1 UTI, 1 asthma exacerbation, 1 voiding dysfunction and 1 pain. For V without DU, complications were 2 small cystotomies and 3 voiding dysfunctions. CONCLUSIONS: In patients with VV, RPS appears to be safe and effective. Between V and N, no differences were seen in rates of subjective success, revisions, or complications, even for the subset of patients with VV and without appreciable detrusor contraction. Perioperative Outcomes, Complications and Revisions Parameter Non- Valsalva Voiders (N) Valsalva Voiders (V) p value Valsalva (-) DU Valsalva (+) DU p value n (%) 75 (53%) 66 (47%) 58 (77%) 17 (23%) Failed Initial Voiding Trial (%) 30 (45%) 29 (37%) 0.392 21 (36%) 7 (41%) 0.779 Catheter Time (days) 3.5  3.1 2.9  3.3 0.244 3.0  3.4 2.4  2.9 0.508 Clean Intermittent Catheterization Rate (%) 7 (11%) 7 (9%) w1.000 6 (10%) 1 (6%) w1.000 Revision Rate (%) 9 (14%) 7 (11%) 0.440 6 (12%) 1 (7%) w1.000 Complication Rate (%) 10 (15%) 9 (12%) 0.630 5 (9%) 4 (25%) 0.095 Clavien Grade (%) 0.062 0.074 1 4 (6%) 4 (5%) 3 (5%) 1 (6%) 2 1 (2%) 4 (5%) 1 (2%) 3 (18%) 3 5 (8%) 0 (0%) 0 (0%) 0 (0%) 4 0 (0%) 1 (1%) 1 (2%) 0 (0%) Voiding Dysfunction (%) 2 (3%) 4 (5%) 0.685 3 (5%) 1 (6%) w1.000 Source of Funding: None e720 THE JOURNAL OF UROLOGY â Vol. 193, No. 4S, Supplement, Monday, May 18, 2015 View publication stats View publication stats