Faculty Bibliography

PURPOSE: There is controversy regarding performing concomitant anti-incontinence procedures at the time of pelvic organ prolapse (POP) repair. Data supports improvement in stress urinary incontinence (SUI) with concomitant sling, but increased adverse events. We assessed trends in preoperative SUI evaluation, concomitant anti-incontinence procedure at POP surgery, and post-operative anti-incontinence procedures at our institution before and after the 2011 FDA Public Health Notification pertaining to vaginal mesh. MATERIALS AND METHODS: A retrospective review was performed on patients who underwent POP surgery from 2009-2015. Preoperative workup included assessment of subjective SUI and/or evaluation for leakage with reduction of POP on physical exam, urodynamics or pessary trial. Percentage of concomitant and post-operative anti-incontinence procedures were compared before and after the 2011 FDA notification. RESULTS: 775 women underwent POP repair. The percentage of anti-incontinence procedures at POP repair decreased from 54.8% to 38.0% after the FDA notification (p = 0.002) while the incidence of pre-operative objective SUI on exam, urodynamics and pessary trials remained constant. The incidence of post-operative anti-incontinence procedures within one year of the index surgery remained low. CONCLUSIONS: We found a decrease in incidence of concomitant anti-incontinence procedures at the time of POP repair following the 2011 FDA notification despite no significant decline in subjective SUI or demonstrable SUI on preoperative evaluation. Further analysis is warranted to assess the impact of the FDA notification on management patterns of women with POP and SUI.

AIMS: Antibiotic prophylaxis before urodynamic testing (UDS) is widely utilized to prevent urinary tract infection (UTI) with only limited guidance. The Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU) convened a Best Practice Policy Panel to formulate recommendations on the urodynamic antibiotic prophylaxis in the non-index patient. METHODS: Recommendations are based on a literature review and the Panel's expert opinion, with all recommendations graded using the Oxford grading system. RESULTS: All patients should be screened for symptoms of UTI and undergo dipstick urinalysis. If the clinician suspects a UTI, the UDS should be postponed until it has been treated. The first choice for prophylaxis is a single oral dose of trimethoprim-sulfamethoxazole before UDS, with alternative antibiotics chosen in case of allergy or intolerance. Individuals who do NOT require routine antibiotic prophylaxis include those without known relevant genitourinary anomalies, diabetics, those with prior genitourinary surgery, a history of recurrent UTI, post-menopausal women, recently hospitalized patients, patients with cardiac valvular disease, nutritional deficiencies or obesity. Identified risk factors that increase the potential for UTI following UDS and for which the panel recommends peri-procedure antibiotics include: known relevant neurogenic lower urinary tract dysfunction, elevated PVR, asymptomatic bacteriuria, immunosuppression, age over 70, and patients with any indwelling catheter, external urinary collection device, or performing intermittent catheterization. Patients with orthopedic implants have a separate risk stratification. CONCLUSIONS: These recommendations can assist urodynamic providers in the appropriate use of antibiotics for UDS testing. Clinical judgment of the provider must always be considered.

Background: Overactive bladder (OAB) is a chronic condition that can cause significant burden and have a negative effect on patients' daily lives. There is a need to offer patients with OAB who are inadequately managed by an anticholingergic alternative therapies that are effective and improve quality of life (QOL) over the long-term. A long-term extension study involving patients with OAB and urinary incontinence (UI) who were inadequately managed by an anticholinergic (ACH) demonstrated that onabotulinum toxin A 100U provides consistent, long-term improvement of OAB symptoms. Here we evaluated the long-term effects of onabotulinum toxin A 100U on QOL in this extension study. Methods: Eligible patients who completed either of two phase 3 trials could enter a three-year extension study to receive onabotulinum toxin A treatment "as needed" for control of symptoms. Results are reported for up to six treatments. Assessments included change from baseline in Incontinence-QOL (I-QOL) total score and proportions of patients who achieved/exceeded the minimally important difference (MID) in I-QOL score (+10 points) after each treatment. Consistency of response over repeat treatments was evaluated by determining whether patients achieved >=MID after the first treatment, and then analyzing the proportion who achieved >=MID for all subsequent treatments. Results: Of 829 patients enrolled, discontinuations due to lack of efficacy/ adverse events were 5.7%/5.1%. After onabotulinum toxin A treatments 1-6, QOL improvements were consistently maintained at 2-3X MID across treatment cycles, with most patients achieving >=MID (range 65.2-76.1%). 72.9% of patients who achieved >=MID after treatment 1 maintained I-QOL improvements >=MID in all subsequent treatments. Over one-third (38.3%) of patients not achieving >=MID after treatment 1 achieved improvements >=MID in all subsequent treatments. No new safety signals were observed. Conclusions: Consistent improvements in OAB symptoms after long-term treatment with onabotulinum toxin A corresponded with durable QOL improvements, with no new safety signals. Patients with clinically meaningful QOL improvements after treatment 1 had similar improvements in subsequent treatments, while lack of response to treatment 1 did not preclude positive response(s) in subsequent treatments. These results help set treatment expectations of patients and clinicians for onabotulinum toxin A and support persistence of its use over the long-term. Additional analyses may further characterize the long-term effects of treatment with onabotulinum toxin A in patients with OAB inadequately managed by an ACH

Background: Pharmacotherapy is the second-line treatment for overactive bladder (OAB) after behavioral therapy, but there is a high discontinuation rate due to inadequate efficacy and/or intolerable side effects. Onabotulinum toxin A provides an additional treatment option for OAB in patients who are inadequately managed by an anticholinergic. This is the first comparison of the efficacy of all licensed doses of anticholinergics, mirabegron, and onabotulinum toxin A vs. placebo in adults with idiopathic overactive bladder using network meta-analysis (NMA) and meta-regression (NMR). Methods: Electronic databases, review documents, guidelines, and websites were searched for randomized blinded trials of >=2 weeks duration comparing any dose of onabotulinum toxin A, mirabegron, or oral/ transdermal anticholinergics with each other or placebo. Networks were developed for outcomes of interest based on studies of similar quality of study methods, confounding factors, common treatment arms, and outcomes measured. Bayesian random effects NMA (for the outcome of 100% reduction in urinary incontinence episodes [UIE]) and NMR (for outcomes on changes from baseline in UIE, urgency episodes, and micturition frequency) models were used to synthesize results at Week 12. Safety outcomes were not compared due to differences in adverse event profiles. Results: One hundred two trials were assessed. NMRs indicated that, after adjusting for differences in baseline severity between trials, all treatments were more efficacious than placebo. Patients who received onabotulinum toxin A (100U) had the greatest mean reductions in UIE (1.55 episodes/ day more than placebo [95% credible interval (CrI) 1.10, 2.01]), urgency (2.01 episodes/day more than placebo [CrI 1.48, 2.54]) and micturition frequency (1.37 episodes/day more than placebo [CrI 1.03, 1.70]). Onabotulinum toxin A patients also had the highest likelihood of achieving 100% UIE reduction (OR 4.30 vs. placebo [CrI: 3.03, 6.23]). Conclusions: This analysis suggests that onabotulinum toxin A 100U provides the greatest reduction in OAB symptoms and higher likelihood of being dry, relative to placebo, than all licensed doses of anticholinergics and mirabegron in the network. Additional studies should also evaluate the cost-effectiveness of onabotulinum toxin A vs. other OAB treatments

BACKGROUND: Nocturia (interruption of sleep due to the need to urinate) affects an estimated 15% of men and 20% of women.
OBJECTIVE(S): To assess baseline data from a 1-year, prospective, observational study in order to estimate the humanistic and economic burden, including work productivity, healthcare resource utilization (HRU) and costs, associated with nocturia in adult patients.
METHOD(S): Adult patients enrolled in HealthCare Partners (HCP) Medical Group with nocturia for >= 6 months were recruited based on claims with ICD-9 codes for nocturia alone (788.43), or combined with overactive bladder (596.51) and/or benign prostatic hyperplasia (600.0x). Demographic, nocturia, and treatment history, as well as quality of life and work productivity data (using the EQ-5D and WPAI, respectively) were obtained through telephone, web-based, or in-clinic questionnaires. HRU (outpatient, emergency room [ER], hospital, and pharmacy utilization) and costs were identified from HCP claims in the 6 months before study enrollment. Results were stratified by nocturia frequency (1, 2-3, >= 4 episodes/night).
RESULT(S): 899 patients were enrolled. With increasing nocturia episodes, EQ-5D mean scores decreased (0.86 +/- 0.1, 0.83 +/- 0.2, 0.80 +/- 0.2 for 1, 2 to 3, >= 4 episodes respectively; P < 0.01), while impact on work productivity increased in working participants (n = 196; 9.6% +/- 17.7%, 18.4% +/- 23.0%, 22.3% +/- 28.0% for 1, 2-3, >= 4 episodes; P = 0.01). The proportion of patients visiting a primary care physician (85.1%, 93.0%, 91.0% for 1, 2-3, >= 4 episodes; P = 0.005), as well as the number of visits/patient (2.6 +/- 1.9, 3.3 +/- 2.6, 3.5 +/- 2.3 for 1, 2-3, >= 4 episodes; P = 0.002), increased with nocturia frequency. The proportion of patients with any prescription claim (76.8%, 90.3%, 88.3% for 1, 2-3, >= 4 episodes; P < 0.001) and the mean number of prescriptions/patient (16.8 +/- 13.4, 20.9 +/- 16.0, 25.1 +/- 20.6 for 1, 2-3, >= 4 episodes; P < 0.001) increased with nocturia frequency. ER visits and hospitalizations followed similar trends but were not statistically significant due to the small number of patients with qualifying event(s). Health plan paid total costs, including hospitalizations, ER visits, outpatient visits, and prescriptions, also increased with nocturia frequency (median costs: $1,618, $2,424, $2,969 for 1, 2-3, >= 4 episodes).
CONCLUSION(S): The humanistic and economic burden of nocturia increases with nocturic frequency. This suggests that management focused on reducing nocturic episodes may reduce HRU and associated costs and improve quality of life among patients with nocturia