Jennifer Gruenenfelder

Polypropylene mesh tape for stress urinary incontinence: complications of urethral erosion and outlet obstruction.

PURPOSE Gynecare tension-free vaginal tape (Ethicon, Inc., New Brunswick, New Jersey) is a propylene mesh tape recently introduced in the United States as minimally invasive treatment for stress urinary incontinence. We report the combined experience at 3 tertiary care institutions with graft erosion and bladder outlet obstruction after procedures performed elsewhere. MATERIALS AND METHODS We reviewed the records of 5 patients with complications who presented to 1 of 3 institutions after polypropylene mesh tape placement. All pertinent information was obtained from the medical records and the operating surgeon at the referring institution. RESULTS Treatment was required in 2 patients with urethral erosion, 1 with vaginal and bladder erosion, and 2 with bladder outlet obstruction. Common presenting symptoms included urge, urge incontinence and gross hematuria. Cystoscopy showed polypropylene graft erosion at the urethra or through the bladder wall. Each patient required explantation of the polypropylene mesh tape and further surgery to restore continence. The graft was divided transvaginally in the 2 patients presenting with outlet obstruction. Urge incontinence resolved and they returned to complete spontaneous voiding. CONCLUSIONS High clinical suspicion is necessary when evaluating patients presenting with urinary symptoms after polypropylene mesh tape placement. Bladder outlet obstruction and possible graft erosion should be considered.

Acute urinary retention associated with the use of cyclooxygenase-2 inhibitors

Case 1. An 89-year-old woman with insulin-dependent diabetes, hypertension, congestive heart failure and atrial fibrillation presented to the emergency department with chief complaints of low urine output, poor urinary stream and urinary incontinence 2 days after starting rofecoxib for right shoulder pain. Blood urea nitrogen (BUN) and creatinine were elevated to 82 mg./dl. (normal 8 to 20) and 2.2 mg./dl. (normal 0.6 to 1.0), respectively, from baselines of 51 mg./dl. and 1.6 mg./dl., respectively, 2 weeks prior. Urinalysis revealed a pH of 5.5, specific gravity of 1.015 and acellularity. Post-void residual urine volume was elevated at 200 cc and an indwelling urethral catheter was placed. Four days later the catheter was removed, and the patient was able to void to completion. Repeat BUN and creatinine were 54 mg./dl. and 1.6 mg./dl., respectively. Case 2. A 72-year-old woman was hospitalized for ischemic heart disease. Co-morbidities included osteoarthritis. Five days prior to admission the patient had been placed on rofecoxib for lower extremity joint pain. Urological inpatient consultation was requested because of an episode of acute urinary retention. She had no prior voiding complaints, or history of urological or gynecological surgery. Physical examination was unremarkable. Initial catheterized bladder volume was 1,200 cc. Urinalysis was normal, and BUN and creatinine were 30 mg./dl. and 1.5 mg./dl., respectively. The patient was taking no other medications. She was started on an intermittent catheterization program, and rofecoxib was discontinued. Twenty-four hours after discontinuation of rofecoxib, the patient began voiding spontaneously with negligible post-void residual urine volumes. Case 3. A 75-year-old man with mild lower urinary tract symptoms managed with an -blocker had acute worsening of symptoms 1 week after initiation of celecoxib for treatment of arthritis pain. Physical examination was unremarkable. The prostate was approximately 40 gm. and benign. Urinalysis was unremarkable. Post-void residual urine volume was 150 cc, which was significantly elevated over a volume of 60 cc measured 3 months prior. The patient remained on tamsulosin, but celecoxib was discontinued. By day 7 his normal voiding pattern had resumed, with a post-void residual urine volume of 45 cc and a return to baseline voiding symptoms. DISCUSSION

Impact of onabotulinumtoxinA on quality of life and practical aspects of daily living: A pooled analysis of two randomized controlled trials

To evaluate the impact of onabotulinumtoxinA on individual domains of the quality of life questionnaires in a pooled analysis of two phase 3 trials in overactive bladder patients with urinary incontinence who were inadequately managed by ≥1 anticholinergic.

PD26-10 ONABOTULINUMTOXINA PROVIDES EARLY AND CONSISTENT IMPROVEMENTS IN OVERACTIVE BLADDER SYMPTOMS AND QUALITY OF LIFE OUTCOMES IN PATIENTS WITH OVERACTIVE BLADDER

INTRODUCTION AND OBJECTIVES: OnabotulinumtoxinA (onabotA) 100U was shown to significantly reduce urinary incontinence (UI) and improve quality of life (QOL) at week (wk) 12 after treatment (tx) in overactive bladder (OAB) patients (pts) in 2 large, placebo (pbo)controlled phase 3 trials. The earliest time for tx response was not assessed in the phase 3 trials. Here we present an interim analysis of an ongoing post-marketing study of onabotA tx response and QOL outcomes as early as wk 1 postinjection in OAB pts with UI. METHODS: OAB pts were randomized 1:1 to receive their 1st tx with onabotA 100U (n1⁄4129) or pbo (n1⁄4125). Pts could receive an additional tx with open-label onabotA 100U after fulfilling prespecified criteria. This interim analysis presents data up to wk 12 after tx 1. Assessments at wks 1, 2, 6 and 12 (primary timepoint) postinjection included the proportions of pts who achieved 100% UI reduction (ie, 00dry00; co-primary endpoint) and 75% and 50% UI reduction, mean change from baseline in daily episodes of urgency UI, micturition, nocturia, and in the Incontinence-QOL (I-QOL) total score. Adverse events (AEs) were also assessed. RESULTS: Baseline mean UI episodes/day were 5.4 (onabotA) and 6.0 (pbo). As early as wk 1 after onabotA, significantly higher proportion of pts achieved 100% UI reduction vs pbo (24.0% vs 4.8%) and continued through wk 2 (25.6% vs 5.6%), wk 6 (32.6% vs 8.0%) and wk 12 (31.8% vs 7.2%) (P<.001 for all timepoints). Similarly, a significantly higher proportion of onabotA-treated vs pbo pts achieved 75% and 50% UI reduction as early as wk 1 (45.0% vs 20.8%, and 58.9% vs 36.0%, respectively; P<.001 for both) which continued through wk 12. Decreases were noted with onabotA vs pbo in other urinary symptoms as early as wk 1 and continued through wk 12. The early onset of onabotA response was also evidenced by the significantly greater improvements in I-QOL score at wk 1 (14.3 vs 5.6; P<.001) that were ~1.5x the minimally important difference (MID; +10 points). At wks 2-12 after onabotA, improvements in I-QOL score were consistently ~23x the MID and significantly greater than pbo (P<.001 for all timepoints). OnabotA was well tolerated; urinary tract infection was the most common AE (21.1% vs 6.4%). CONCLUSIONS: This interim analysis showed a significant and consistent tx response with onabotA vs pbo in OAB pts as early as wk 1 postinjection, with significant reductions in UI episodes and improvements in OAB symptoms and QOL outcomes which continued through wk 12. OnabotA was well tolerated.