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Vaginal estrogen for the prevention of recurrent urinary tract infection in postmenopausal women: A randomized clinical trial

Ferrante, Kimberly L.; Wasenda, Erika J.; Jung, Carrie E.; Adams-Piper, Emily R.; Lukacz, Emily S.
Recurrent urinary tract infection (rUTI) is defined as at least 2 UTIs in a 6-month span or 3 UTIs in a 1-year span. Postmenopausal status is a well-described risk factor for rUTI, with declining levels of systemic estrogen hypothesized as a contributory biological mechanism. Topical vaginal estrogen is commonly prescribed for prevention of rUTI; however, few studies assess the safety and efficacy of current doses and formulations. This multicenter, single-blind, randomized, placebo-controlled trial aimed to evaluate the efficacy of vaginally administered estrogen in 2 preparations (estradiol ring or conjugated estrogen cream) compared with placebo at 6 months in the prevention of UTI among postmenopausal women with rUTI. Postmenopausal women receiving care for rUTI were recruited at clinics associated with 3 academic institutions. Participants were randomized to vaginal estrogen, either estradiol ring containing 2 mg of estradiol placed every 3 months or conjugated estrogen cream at a strength of 0.625 mg/g dosed at 0.5 g twice a week, or placebo cream in a 1:1:1 fashion. The primary study outcome of UTI was assessed at 6 months or the end of study blinding. If a participant developed 3 UTIs in the 6-month period, they were unblinded and if on placebo treated accordingly. Open-label use of estradiol ring or conjugated estrogen cream was offered after unblinding until month 12 of the study. Because of low recruitment, original sample size calculations and randomization schema were revised with vaginal estrogen groups combined and patients block randomized to receive either vaginal estrogen (via ring or cream) or placebo in a 1:1 fashion. Over a 3-year duration, 45 women were referred for enrollment, and 35 were randomized. A total of 26 women were included in the primary analysis, with 11 women randomized to placebo, 8 to estradiol ring, and 7 to estrogen cream. The intent-to-treat analysis found fewer women treated with vaginal estrogen had a UTI by 6 months when compared with placebo (50% [9/18] vs 94% [16/17], P = 0.041). This significance was maintained in the as-treated analysis. Subanalysis of the as-treated groups revealed fewer women in the ring group had a UTI by 6 months compared with placebo (38% [3/8] vs 91% [10/11], P = 0.041), whereas there was no statistically significant difference between estrogen cream and placebo (71% [5/7] vs 91% [10/11], P = 0.245). Among the 10 women initially randomized to placebo that continued on to open-label vaginal estrogen, a significant decrease in occurrence of UTI was observed (90% with UTI pre-estrogen vs 30% post-estrogen, P = 0.042). Adherence to treatment at 6 and 12 months was 100% among the ring group versus 57% and 60%, respectively, among the cream group. Despite small sample size, the results of this study show that vaginal estrogen is superior to placebo in the prevention of UTI occurrence among postmenopausal women with an active diagnosis of rUTI. Although the study was not designed to compare relative efficacy of vaginal estrogen, results show that compliance with the estrogen ring was superior to the cream, and this likely resulted in improved rates of UTI prevention among those randomized to the ring.
SCOPUS:85106913531
ISSN: 0029-7828
CID: 4921622

Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized Clinical Trial

Ferrante, Kimberly L; Wasenda, Erika J; Jung, Carrie E; Adams-Piper, Emily R; Lukacz, Emily S
OBJECTIVES/OBJECTIVE:We aimed to compare the efficacy of 2 commonly used contemporary vaginal estrogen administrations versus placebo for the prevention of urinary tract infection (UTI) in postmenopausal women with a clinical diagnosis of recurrent UTI (rUTI). METHODS:This was an investigator-initiated, multicenter, single-blind, randomized, placebo-controlled trial of vaginal estrogen (delivered via ring or cream) compared with placebo. Postmenopausal women with documented rUTI were randomized to receive either vaginal estrogen (via ring or cream) or placebo cream in a 1:1:1 fashion. The primary outcome was occurrence of UTI at 6 months. After 6 months, open-label use of ring or active cream was offered to all participants for an additional 6 months. Because of slower than expected recruitment, sample size calculations and block randomization schema were revised to combine estrogen groups (ring or cream) for statistical comparisons to placebo cream in a 1:1 fashion. RESULTS:Thirty-five women were randomized with 9 dropouts (1 ring, 2 cream, and 6 placebo) prior to the 6 months. Intention-to-treat analysis (assuming dropouts as failures) revealed fewer women treated with vaginal estrogen had a UTI within 6 months versus placebo (11/18 vs 16/17, respectively; P = 0.041). Per-protocol analysis revealed fewer subjects treated with vaginal estrogen had a UTI at 6 months (8/15 vs 10/11, respectively; P = 0.036). CONCLUSIONS:Commonly prescribed forms of vaginal estrogen with contemporary dosing schedules prevent UTIs in postmenopausal women with an active diagnosis of rUTI.
PMID: 31232721
ISSN: 2154-4212
CID: 4075682

Persistence in percutaneous tibial nerve stimulation treatment for overactive bladder syndrome is best predicted by patient global impression of improvement rather than symptom-specific improvement

Brandon, Caroline; Oh, Cheongeun; Brucker, Benjamin M; Rosenblum, Nirit; Ferrante, Kimberly L; Smilen, Scott W; Nitti, Victor W; Pape, Dominique Malacarne
OBJECTIVES/OBJECTIVE:To evaluate whether progression to maintenance percutaneous tibial nerve stimulation (PTNS) was related to perceived global impression of improvement (PGII) rather than symptom-specific improvement in patient with overactive bladder (OAB). We hypothesize that PGII will predict continuation of PTNS long-term. METHODS:This prospective observational study included 90 patients with OAB that initiated PTNS. The PGII and overactive bladder short-form questionnaires (OABq-SF) were used to assess bladder symptom severity and improvement. Those that completed the 12-week induction phase were offered to continue PTNS monthly maintenance or pursue other options. The primary outcome was difference in PGII score between those pursuing maintenance therapy versus other options. Descriptive statistics and mixed effect modeling analysis were employed. RESULTS:Seventy patients (78%) completed 12 weeks of PTNS. The majority of completers pursued monthly maintenance (p<0.01) and had significantly lower median PGII scores compared with those who sought alternatives (p<0.01), while OABq-SF scores did not differ significantly (p=0.65). Patients that pursued monthly PTNS maintenance had lower body mass index than those who chose alternative therapies (p<0.01). Only 19% continued PTNS therapy for at least 1 year. CONCLUSIONS:More patients pursued PTNS monthly maintenance over any other therapy, and this was significantly associated with lower PGII scores. Global improvement, and not symptom-specific response, predicts long-term PTNS maintenance. No symptom-specific predictors were identified in those who pursued maintenance over other options. One-year continuation rates are low.
PMID: 33358753
ISSN: 1527-9995
CID: 4731262

Post-ptns trends-who commits? a prospective cohort study evaluating post-PTNS treatment in overactive bladder [Meeting Abstract]

Brandon, C; Brucker, B; Smilen, S; Rosenblum, N; Ferrante, K; Nitti, V; Malacarne-Pape, D
Introduction: Percutaneous tibial nerve stimulation (PTNS) is an efficacious treatment option for overactive bladder syndrome (OAB). There is a paucity of data surrounding long-term efficacy of PTNS and limited studies are aimed at characterizing those patients who seek post-PTNS follow up maintenance. The aim of this study was to evaluate those who completed PTNS treatment and continued with posttreatment PTNS maintenance versus alternative therapeutic options.
Method(s): This is a prospective cohort study at a single academic institution. Ninety patients started PTNS according to our clinical protocol. The Patient Global Impression of Severity (PGIS) and Patient Global Impression of Improvement (PGII), and OAB Short Form (OABq-SF) questionnaires were used to assess OAB symptom severity and improvement, respectively. Following 12 sessions, patients were given the choice to continue maintenance PTNS or to pursue other options.
Result(s): Our completion rate was 70/90 (77.8%). Of all patients who continued some type of therapy for OAB, significantly more patients went on to monthly PTNS maintenance compared with all other options (54.3% vs 37.1%, P=0.02). There were no differing demographic features between those who pursued Post-PTNS maintenance and those who chose an alternative therapy. Overall OABq-SF scores improved significantly by the end of treatment but did not differ between those who chose PTNS maintenance and those who pursued another treatment. Medications did not improve the perception of improvement when added to PTNS (P=0.45). Individuals who chose PTNS maintenance showed significant improvement in urgency (3.4 (0.89) to 2.6 (0.89); P=0.049) and incontinence (3.2 (1.72) to 2.7 (1.37); P=0.038) over the initial 12 weeks, while those who chose otherwise did not. Individuals who went on to monthly maintenance showed lower PGII scores compared with those who sought alternatives (2.70 (1.6) vs 3.81 (1.07); P=0.01), despite no difference in starting severity of OAB symptoms (PGIS score 3.33 (0.72) vs 3.33 (0.70); P=1).
Conclusion(s): Patients were more likely to continue maintenance PTNS than any other form of treatment. Despite no predictive characteristics found, favorable improvement subscores in urgency and incontinence were associated with those pursuing maintenance therapy. Overall, those who perceived greater improvement were more likely to pursue long-term PTNS therapy as their OAB treatment of choice
EMBASE:632157592
ISSN: 1520-6777
CID: 4549992

Teaching Vaginal Hysterectomy via Simulation: Creation and Validation of the Objective Skills Assessment Tool for Simulated Vaginal Hysterectomy on a Task Trainer and Performance Among Different Levels of Trainees

Malacarne, D R; Escobar, C M; Lam, C J; Ferrante, K L; Szyld, D; Lerner, Veronica T
OBJECTIVES:The use of simulation-based education to train surgeons is widely accepted. Although many authors describe the use of an Objective Skills Assessment Test (OSAT) to assess performance of various surgical procedures, there is a paucity of research on use of this modality to evaluate vaginal surgery skills. We created a vaginal hysterectomy procedure-specific checklist (PSC) to complete the OSAT (which is composed of a PSC and a global rating scale [GRS]). The primary objective of this study is to evaluate the performance of a novel evaluation strategy for vaginal hysterectomy using an OSAT combining PSC and GRS. METHODS:This is a descriptive prospective study from a single institution. After orientation to the model, participants were filmed performing vaginal hysterectomy. A blinded grader scored each subject using the PSC and GRS. RESULTS:Medical students, residents, fellows, and attendings performed vaginal hysterectomy on a simulated model. Mean PSC and GRS scores increased significantly with surgeon level of experience (P < 0.001). Procedure-specific checklist scores significantly correlated with GRS scores (P < 0.001). CONCLUSIONS:The vaginal hysterectomy model and PSC have been studied across different surgeon levels using OSATs. Training programs should consider using this low-cost task trainer as a teaching tool.
PMID: 29443815
ISSN: 2154-4212
CID: 4007762

TRENDS IN POST-PERCUTANEOUS TIBIAL NERVE STIMULATION FOLLOW-UP TREATMENT [Meeting Abstract]

Brandon, Caroline; Malacarne, Dominique; Ringel, Nancy; Rosenblum, Nirit; Brucker, Benjamin; Smilen, Scott; Nitti, Victor; Ferrante, Kimberly
ISI:000427016100216
ISSN: 0733-2467
CID: 3008822

Urologic and Gynecologic Sources of Pelvic Pain

Malacarne, Dominique R; Ferrante, Kimberly L; Brucker, Benjamin M
Gynecologic and urologic etiologies are the sources of pelvic pain for many individuals. This article aims to provide a comprehensive review of the various genitourinary sources of pelvic pain. It is important to recognize that although these disorders predominantly affect women, there are various conditions that affect both men and women, and these should be considered in the differential diagnosis of patients presenting with pelvic pain. Providers who encounter patients with pelvic pain should attempt to localize these symptoms and obtain a comprehensive history from the patient to help direct diagnostic evaluation.
PMID: 28676365
ISSN: 1558-1381
CID: 2616902

Urinary Tract Infection Rates and Mechanisms After OnabotulinumtoxinA Bladder Injection: a Review

Hoffman, D; Ferrante, K L
Purpose of Review: Intradetrusor onabotulinumtoxinA therapy has proven effective in decreasing episodes of urgency urinary incontinence and improving quality of life in patients with refractory idiopathic and neurogenic detrusor overactivity. While the definition and reporting of urinary tract infections as well as dosing of onabotulinumtoxin varied across trials, there was a demonstrated increased risk of developing a urinary tract infection with onabotulinumtoxinA injections when compared to placebo injection. Recent Findings: Occurrence of urinary tract infections was found to persist through multiple treatment cycles, while the rates of catheterization seem to decrease with subsequent treatments. Summary: While multiple theories exist, the current literature has not been able to elucidate the mechanism by which intradetrusor onabotulinumtoxinA injections increase the risk of urinary tract infections.
EMBASE:615088067
ISSN: 1931-7220
CID: 2534152

Patients do not have more urinary tract infections after midurethral sling surgery [Meeting Abstract]

Ferrante, K L; Menefee, S A; Dyer, K Y
Objectives: Recurrent Urinary Tract Infection (UTI) is prevalent in the urogynecologic population. We also know that instrumentation of the urethra predisposes patients to UTI. Increased frequency of UTIs has been observed after midurethral sling surgery (MUS). Richter et al found that baseline recurrent UTI, MUS, bladder perforation and self-catheterization all increased the risk of UTI after incontinence procedures. However, to our knowledge, there is no study comparing the difference in the number of UTIs preoperatively and the number postoperatively after MUS. The primary aim of this study was to look for a difference in number of UTIs pre and postoperatively in women undergoing MUS. Methods: We performed a retrospective chart review of all patients who underwent MUS surgery in the calendar year of 2012 using CPT codes. The number of positive urine cultures (defined as >100 k CFU) in the 12 months pre and post operation, concomitant procedures, as well as demographic and clinical characteristics were abstracted from the medical records. A paired t test was used to look at the difference in the number of UTIs pre and postoperatively. Univariate analyses were used in women who had more UTIs postoperatively to identify potential risk factors. Multivariable logistic regression was then performed. Results: 117 women underwent MUS between January 1st and December 31st 2012. There was not a significant difference between number of UTIs in the year preoperatively and the year postoperatively (p = 0.15). Nineteen women (16%) had more UTIs in the year postoperatively than preoperatively. In those women, discharge home with catheterization (p = 0.02) and prior anti-incontinence surgery (p = 0.05)were both found to be risk factors. If a patient had recurrent UTIs preoperatively (>=3 infections/12 months), this was associated with having continued recurrent UTIs postoperatively (p = 0.002). Conclusions: There was not a difference in number of UTIs pre and postoperatively in patients undergoing MUS surgery. Of the 16% of women who had more frequent UTIs after MUS the need for catheterization postoperatively, prior incontinence surgery, as well as recurrent UTIs were all identified as risk factors, similar to findings from previous studies
EMBASE:618084887
ISSN: 2154-4212
CID: 2691682

Validation of a vaginal hysterectomy task trainer: Using standardized assessment tools for every level of experience [Meeting Abstract]

Malacarne, D R; Lam, C; Ferrante, K L; Szyld, D; Lerner, V T
Objectives: There is general consensus in the surgical community that task and virtual reality trainers, as well as surgical skills labs should be utilized before trainees embark on live surgery (1-4). The objective skills assessment test (OSAT) for assessing resident skills is used as a modality to objectively assess residents' performance, and more recently has been used as a way to troubleshoot skill deficits.[5-9]While a vaginal hysterectomymodel has been developed by Greer and colleagues (10), validation for construct validity using OSATs has not yet been established. Our primary aim was to use OSATs and GRS checklists to assess the construct validity of the vaginal hysterectomy task trainer as a teaching tool. We sought to assess learners of all levels to comprehensively analyze the validity of the task trainer. Methods: All 3rd and 4th year medical students, OB/GYN residents, Female Pelvic Medicine and Reconstructive Surgery (FPMRS) fellows, FPMRS attendings and OB/GYN attendings at our institution received an email invitation to participate in the study. Subjects first took a non-validated pre-test assessing overall general knowledge of performing vaginal hysterectomy. They were then oriented to the model and watched a video demonstrating how to complete a vaginal hysterectomy on the task trainer before performing the task. This assessment was videotaped and a blinded grader graded each subject using OSATS and GRS checklists. Total time to accomplish the task was also recorded. The primary outcome of our study was GRS/OSAT scores for each participant. We also looked at surgical performance time and pre-test scores as secondary outcomes. Results: We recruited 14 medical students, 15 residents, 3 FPMRS fellows, 11 generalist gynecology attendings and 3 FPMRS attendings. Mean GRS and OSAT scores did significantly improve with surgeon level (p<0.001) (Table 1). When comparing students versus residents versus all others the scores improved significantly according to surgical experience (p<0.001) (Table 1). In general, mean time to completion was not significantly different between the groups, however when comparing students and residents versus all others there was a significant improvement in mean time to complete the task (33.7 versus 27.5 minutes respectively) (Table 1). Lastly, mean pre-test scores did improve with level of experience (p=0.05). Conclusions: The vaginal hysterectomymodel can be validated across surgeon level using both general (GRS) and surgery specific (OSAT skills) assessment tools. Using this low cost task trainer as an educational intervention should be considered by training programs for teaching vaginal hysterectomy
EMBASE:618084897
ISSN: 2154-4212
CID: 2691672