Page 2 - CUA2018 Abstracts - Incontinence

Poster session 9: Incontinence

Methods: OAB patients who received onabotA 100 U in three random- 27.1% of patients, respectively, were dry. Mean changes from BL to
ized, placebo–controlled phase 3 trials and a post–marketing study were 12 weeks in KHQ RL and SL were –21.9 and –21.6, respectively, after
stratified by baseline OAB duration (<2 [n=279], 2–5 [n=641], and >5 treatment cycle 1 and –23.3 and –22.7 after treatment cycle 2. Urinary
[n=505] years) and BMI (<25 [n=317], 25–<30 [n=454], 30–<40 [n=502], tract infection was the most common AE.
and ≥40 [n=153] kg/m ). Week 12 assessments: change in UI episodes/ Conclusions: In this large, pooled population of OAB patients, UI and
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day, proportions of patients with 100% UI reduction, and change in QOL improvements were consistent with onabotA retreatment and were
King’s Health Questionnaire (KHQ) domains. Rates of clean intermittent not accompanied by any increased risk of CIC.
catheterization (CIC) and adverse events (AEs) were also recorded.
Results: The mean/percent changes from baseline to Week 12 in UI MP–9.6
episodes/day with onabotA were –3.3/–54.5%, –2.9/–55.1%, and
–3.4/–61.1% in patients with OAB duration of <2, 2–5, and >5 years, The majority of overactive bladder patients do not require
respectively (baseline: 5.3, 5.4, and 5.6), and –2.8/–57.9%, –2.8/–56.4%, specialist care 1 2 1 1
–3.4/–55.5%, and –4.2/–63.1% with BMI <25, 25–<30, 30–<40, and Stephen Strahan , Camille Charbonneau , Trafford Crump , Kevin Carlson ,
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≥40 kg/m respectively (baseline: 5.0, 5.2, 5.7, and 6.5). Proportions of Richard Baverstock 2
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patients with 100% reduction in UI episodes/day were 38.7%, 27.9%, Department of Surgery, University of Calgary, Calgary, AB, Canada; vesia
and 27.9% by OAB duration (<2, 2–5, and >5 years, respectively) and [Alberta Bladder Centre], Calgary, AB, Canada
32.5%, 31.1%, 29.9%, and 22.9% by BMI (<25, 25–<30, 30–<40, and Study Groups: Pfizer Canada Inc.
≥40 kg/m , respectively). KHQ Role and Social Limitations improvements Introduction: Overactive bladder (OAB) is a common condition resulting
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were ~4–6 times the minimally important difference (–5 points) across in a significant number of referrals to specialists. Guidelines recommend
all groups. CIC was used in 6.1%, 4.4%, and 5.0% of patients with OAB patient education and conservative measures prior to medication or inva-
duration <2, 2–5, and >5 years, respectively and in 4.7%, 5.3%, 5.4%, sive techniques to manage OAB. We have established a multidisciplinary
and 2.6% of those with BMI <25, 25–<30, 30–<40, and ≥40 kg/m , model of care employing non–specialist providers in the initial manage-
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respectively. No unexpected safety signals were observed. ment of these patients. We set out to assess patient–reported outcomes
Conclusions: OnabotA 100 U reduced UI episodes, improved quality of (PROs) and satisfaction associated with this model.
life, and was well–tolerated regardless of baseline OAB duration or BMI. Methods: From December 2014 to October 2016 patients referred to
Baseline OAB duration and BMI did not appear to affect onabotA efficacy. our clinic with OAB symptoms were prospectively enrolled. PROs (OAB
v8, International Prostate Symptom Score [IPSS]) were collected at ini-
tial consultation. PROs and patient satisfaction (Consumer Assessment of
MP–9.4 Healthcare Providers and Systems [CAHPS]) were assessed at subsequent
Risk of clean intermittent catheterization was not increased followup visits for 12 months. Those who did not return for a followup
with onabotulinumtoxinA re–treatment: Pooled analysis of visit were mailed a survey package at 12 months. Changes in PROs were
randomized controlled trials assessed using a paired t–test. Conservative therapies and medications
Sidney Radomski , Francisco Cruz , Eric Rovner , Jennifer Sobol , Kurt used were assessed for change in PROs using ordinary least squares.
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McCammon , Rizwan Hamid , Amelia Orejudos , Anand Patel , Gary Results: Of the 301 patients enrolled, 201 (66%) were managed by non–
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Lemack 9 specialist providers without the need to see a urologist. Baseline and end
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1 University of Toronto, Toronto, ON, Canada; Hospital S. João & of study PRO and CAHPS data were available for 135 (67%) of these
Universidade Do Porto, Porto, Portugal; Medical University of South patients. Change in PROs showed statistically significant improvement
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Carolina, Charleston, SC, United States; Michigan Institute of Urology, over the 12–month period. The mean OAB v8 and IPSS scores improved
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West Bloomfield, MI, United States; Eastern Virginia Medical School, by 5.4 and 4.3, respectively (p<0.001 for each). No single conservative
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Norfolk, VA, United States; University College London Hospitals, London, therapy or medication made a statistically significant improvement in
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United Kingdom; Allergan plc, Irvine, CA, United States; Allergan plc, PROs on univariate analysis. Patient satisfaction based on CAHPS overall
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Marlow, United Kingdom; University of Texas Southwestern Medical rating was high (8.9/10).
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Center, Dallas, TX, United States Conclusions: The majority of OAB patients do not require management
Study Groups: Funding: Allergan plc. by a specialist to achieve a satisfactory outcome .
Introduction: This post–hoc analysis of pooled placebo–controlled trials
was undertaken to evaluate the risk of clean intermittent catheterization MP–9.7
(CIC), as well as efficacy and quality of life (QOL) outcomes following
onabotulinumtoxinA (onabotA) re–treatment. Preoperative pad usage is independently associated with failure
Methods: Overactive bladder (OAB) patients who received onabotA 100 of non–adjustable male transobturator slings in otherwise well–
U in three randomized, placebo–controlled, phase 3 trials and a post– selected patients 1 1 1
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marketing study were included. CIC incidence was evaluated at week Logan Zemp , Steven Tong , Nathan Hoy , Keith Rourke
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12 following treatment cycles 1 and 2. In each study, patients could be Division of Urology, University of Alberta, Edmonton, AB, Canada
retreated as needed/requested if they met the predefined criteria. The Introduction: The purpose of this study is to determine which clinical
mean change from baseline (BL) in urinary incontinence (UI) episodes/ factors are associated with non–adjustable transobturator sling failure
day, proportions of patients with 100% reduction in UI (i.e., “dry”), and in properly selected men undergoing treatment for post–prostatectomy
mean changes from BL in King’s Health Questionnaire (KHQ) Role (RL) incontinence (PPI).
and Social Limitations (SL) domains were assessed at week 12 after treat- Methods: A retrospective review of Advance/Advance XP transobturator
ment cycles 1 and 2. Adverse events (AEs) were recorded. male sling procedures for PPI was performed over a 10–year period.
Results: CIC rates in the first 12 weeks following the first treatment Patients with known risk factors for sling failure, including severe incon-
were 5.3% (44/825) for onabotA and 0.1% (1/727) for placebo. In the tinence (>5 pads), radiation therapy, untreated detrusor overactivity, or
12 weeks after the second treatment, CIC rates were 5.3% (25/469) for neurogenic detrusor dysfunction, were excluded from the study. Clinical
those who received onabotA in both treatment cycles; the majority were factors examined were patient age, Charlson Comorbidity Index (CCI),
de novo CIC patients (17/469, 3.6%). Only eight patients who received diabetes, obesity (body mass index [BM] I>35), type of prostatectomy,
onabotA treatments twice required CIC within 12 weeks following each and number of preoperative pads. The primary outcome measure was
treatment. Correspondingly, the CIC rate was 3.1% (18/582) for those failure to achieve continence, defined as one or less pads postoperatively
patients who received their first onabotA treatment in cycle 2. Mean if preoperative pads were ≥2, or 0 pads if preoperative pad use was
change in UI episodes/day from BL (5.4) to 12 weeks was –2.9 after one. Descriptive statistics and univariate and multivariate Cox regression
onabotA treatment cycle 1 and –3.5 after treatment cycle 2; 29.1% and analysis was performed using SPSS24.
Results: Out of 158 patients, continence was achieved in 82.3% (n=130)
S114 CUAJ • June 2018 • Volume 12(6Suppl2)