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Brucker, Benjamin M; Wasserman, Meredith C
PMID: 36773989
ISSN: 1527-9995
CID: 5421092

The PSR13, a tool for evaluating patient-perceived recovery after vaginal prolapse repair surgery

Brandon, Caroline A; Friedman, Steven; Rosenblum, Nirit; Escobar, Christina M; Stewart, Lauren E; Brucker, Benjamin M
INTRODUCTION AND HYPOTHESIS/OBJECTIVE:Surgical recovery is the return to preoperative functional, psychologic, and social activity, or a return to normalcy. To date, little is known about the global post-surgical recovery experience from the patients' perspective. The aim of this study was to validate the Post-Discharge Surgical Recovery scale 13 (PSR13) in women undergoing vaginal prolapse repair procedures and evaluate the patient-perceived postoperative recovery experience over a 12-week period. METHODS:Fifty women undergoing vaginal prolapse repairs completed the PSR13 and global surgical recovery scale (GSR) at 1, 2, 4, 6, and 12 weeks post-surgery. Validity, the minimal clinically important difference (MCID), and responsiveness to change over time of the PSR13 was evaluated using descriptive statistics and linear regression models. The proportion of patients deemed fully recovered at each time point (defined as PSR13 score ≥ 80) was also assessed. RESULTS:The PSR13 correlated significantly (p < 0.001) with the single-item recovery scale and showed excellent internal consistency reliability (Cronbach α = 0.91, range 0.77 to 0.93). The MCID was estimated at 7.0 points. The PSR13 scores improved at varying rates over time, with the greatest amount of patient-perceived recovery occurring between 4 and 6 weeks after surgery. The proportion of patients deemed fully recovered at 6- and 12- weeks postoperatively was 37% and 56%, respectively. CONCLUSIONS:The PSR13 is a useful instrument to assess overall return to normalcy from the patient's perspective and can be applied to evaluate the recovery experience among women undergoing vaginal prolapse repairs, in both the research and clinical setting.
PMID: 36166063
ISSN: 1433-3023
CID: 5334192

Defining Bladder Outlet Obstruction in Women

Escobar, Christina; Jericevic, Dora; Brucker, Benjamin M.
Purpose of Review: The goal of this paper is to provide the reader with an understanding of the definition of bladder outlet obstruction (BOO) in females and guidance on the diagnostic work-up of this condition. Recent Findings: Our understanding of female BOO is continuing to evolve. Urodynamics and fluoroscopy can aid in the diagnosis of this condition. Several new definitions of BOO in females have been studied and provide more clarity for female BOO. However, no one definition has proved to be superior. Therefore, there is no replacement for looking at the entire clinical picture including patient history, examination and urodynamic data if available. Summary: Recent studies have further contributed to the body of literature on how to define bladder outlet obstruction in women, but no current consensus exists on the best way to define this condition.
ISSN: 1931-7212
CID: 5329792

Thirty-six-month Prospective Study of Transvaginal Bovine Graft vs Native Tissue Repair for the Treatment of Pelvic Organ Prolapse

Lipetskaia, Lioudmila; Gonzalez, Ricardo R; Wu, Jennifer M; Northington, Gina M; Henley, Barbara R; Lane, Felicia; Brucker, Benjamin M; Jarnagin, Barry; Rosenblatt, Peter L
OBJECTIVE(S)/OBJECTIVE:To compare the safety and effectiveness of dermal bovine transvaginal graft, Xenform, to native tissue in the surgical treatment of anterior and/or apical pelvic organ prolapse. This study was designed in conjunction with Food and Drug Administration requirements. METHODS:This was a prospective, non-randomized, parallel cohort, multi-center trial. The primary objective was to demonstrate noninferiority between transvaginal graft and native tissue repair at 36 months compared to baseline. Treatment success was based on a composite of objective and subjective measures. The co-primary outcome was the rate of serious device- or procedure-related adverse events. A total of 228 patients at 25 sites were included in the study arm and 485 patients underwent native tissue repair. Propensity score stratification was applied to achieve balance between treatment groups. Study outcomes were compared in per protocol and intent-to-treat analysis. RESULTS:The primary outcome, treatment success at 36 months, was 83.6% (191/228) for transvaginal graft and 80.5% (390/485) native tissue repair (0.2%, 90% confidence interval [-5.6% to 5.9%]), demonstrating noninferiority at a preset margin of -12%. The overall rate of severe adverse events was 5.3% (12/228) in transvaginal graft vs 2.7% (13/485) in native tissue repair groups. The study group demonstrated noninferiority in serious adverse events at the preset margin of 11.6% (2.0%, 90% confidence interval [-0.8% to 4.7%]). There were no reports of graft erosion, and graft exposure rates were low (0.9% [2/228]). CONCLUSIONS:Transvaginal repair of anterior and/or apical prolapse with a biological graft is noninferior to traditional native tissue repair in effectiveness and safety at 36 months.
PMID: 35716871
ISSN: 1527-9995
CID: 5282882

Intravesical Instillation of OnabotulinumtoxinA in the Treatment of Refractory Overactive Bladder in Participants with Urinary Incontinence

Chermansky, Christopher J; Richter, Holly E; Jacoby, Karny; Titanji, Wilson; Jenkins, Brenda; Geib, Till; Brucker, Benjamin M
PURPOSE/OBJECTIVE:Intradetrusor injections of onabotulinumtoxinA are efficacious for the treatment of overactive bladder with urgency urinary incontinence in adults refractory to or intolerant of anticholinergics. Delivery of onabotulinumtoxinA via instillation would reduce the need for intradetrusor injections. The objective of this trial was to assess the efficacy and safety of intravesical instillation of an onabotulinumtoxinA + hydrogel admixture. MATERIALS AND METHODS/METHODS:After review of a stage 1 safety phase by an independent committee, participants were recruited into stage 2 and randomized to either onabotulinumtoxinA 100, 300, 400, or 500 U, or placebo, all with hydrogel admixture. End points included change from baseline to week 12 in the number of urinary incontinence episodes (primary); micturition, urgency urinary, and nocturia episodes/day; volume voided per micturition; proportion of participants with a ≥50% decrease from baseline in urinary incontinence episodes/day; and Overactive Bladder Questionnaire total score. Adverse events were reported. RESULTS:Change from baseline to week 12 in number of urinary incontinence episodes was -2.72 with placebo and ranged from -0.89 to -1.85 in the onabotulinumtoxinA + hydrogel treatment groups. No difference from placebo was observed for any efficacy end point. The proportions of participants with treatment-emergent adverse events were similar among all groups, with asymptomatic bacteriuria the highest reported (6.7%-15.5%). There were no reports of urinary retention or elevated post-void residual volume. CONCLUSIONS:Intravesical instillation of an onabotulinumtoxinA + hydrogel admixture for the treatment of refractory overactive bladder was well tolerated, but it showed no improvement over placebo.
PMID: 35830550
ISSN: 1527-3792
CID: 5269232

Incomplete bladder emptying and urinary tract infections after botulinum toxin injection for overactive bladder: Multi-institutional collaboration from the SUFU research network

Reynolds, William Stuart; Suskind, Anne M; Anger, Jennifer T; Brucker, Benjamin M; Cameron, Anne P; Chung, Doreen E; Daignault-Newton, Stephanie; Lane, Giulia I; Lucioni, Alvaro; Mourtzinos, Arthur P; Padmanabhan, Priya; Reyblat, Polina X; Smith, Ariana L; Tenggardjaja, Christopher F; Lee, Una J
INTRODUCTION/BACKGROUND:Onabotulinumtoxin A (BTX-A) is an effective therapy for overactive bladder (OAB), however, adverse events may prevent patients from initiating therapy. The study objective was to report real-world rates of incomplete emptying and urinary tract infection (UTI) in men and women undergoing BTX-A for OAB. METHODS:Eleven clinical sites performed a retrospective study of adults undergoing first-time BTX-A injection (100 units) for idiopathic OAB in 2016. Exclusions included: postvoid residual (PVR) > 150 ml, prior BTX-A, pelvic radiation, or need for preprocedure catheterization. Primary outcomes at 6 months were incomplete emptying (clean intermittent catheterization [CIC] or PVR ≥ 300 ml without the need for CIC); and UTI (symptoms with either positive culture or urinalysis or empiric treatment). We compared rates of incomplete emptying and UTI within and between sexes, using univariate and multivariable models. RESULTS:278 patients (48 men and 230 women) met inclusion criteria. Mean age was 65.5 years (range: 24-95). 35% of men and 17% of women had incomplete emptying. Men had 2.4 (95% CI: 1.04-5.49) higher odds of incomplete emptying than women. 17% of men and 23.5% of women had ≥1 UTI, the majority of which occurred within the first month following injection. The strongest predictor of UTI was a history of prior UTI (OR: 4.2 [95% CI: 1.7-10.3]). CONCLUSIONS:In this multicenter retrospective study, rates of incomplete emptying and UTI were higher than many previously published studies. Men were at particular risk for incomplete emptying. Prior UTI was the primary risk factor for postprocedure UTI.
PMID: 35019167
ISSN: 1520-6777
CID: 5118732

Dorsal onlay lingual mucosa graft urethroplasty for female urethral stricture [Meeting Abstract]

Richard, C; Brucker, B; Hascoet, J; Drain, A; Rosenblum, N; Sussman, R; Freton, L; Zhao, L; Peyronnet, B
Introduction & Objectives: The most widely accepted definition of female urethral stricture (FUS) is a symptomatic, anatomical narrowing of the urethra based on a failure of catheterization, urethral calibration, visual inspection, endoscopy or radiography. Thus it is a rare condition, its diagnostic and treatment are challenging for the reconstructive urologist.
Material(s) and Method(s): We present the case of a 47 year-old female, with a urethral stricture due to vulvar lichen sclerosus inducing incomplete bladder emptying and recurrent urinary tract infections. We decided to use lingual mucosa because the buccal mucosa was also affected by the lichen. The aim of this video was to describe the procedure of dorsal onlay lingual mucosa graft urethroplasty.
Result(s): The operating time was 70 minutes. The procedure began with the injection of adrenaline and xylocaine serum. An inverted U incision was performed anterior to the urethra. Dissection was carried out in the plane developed between the underlying urethra and overlying clitoral cavernous tissue. A dorsal urethrotomy was performed at a 12 o' clock position until healthy proximal urethra was reached. The lingual mucosa graft was harvested after having identified the Wharton's duct orifices. The graft edges were incised using a scalpel and the graft was removed using sharp scissors. The graft was maturated by removing the fat and muscular tissue of its non-mucosal side. The graft was sutured to the margins of the urethral plate. The distal part of the graft was quilted to the above periurethral flap in order to recreate the ventral aspect of the urethral meatus. A 18FR silicone catheter was placed carefully at the end of the procedure. No peri operative complication occurred. The patient was discharged two days after surgery and did not have recurrence of stricture after 6 months.
Conclusion(s): Dorsal onlay lingual mucosa graft urethroplasty is a feasible option for female urethral stricture with satisfactory postoperative outcomes.
ISSN: 1873-7560
CID: 5184542

Selectivity and Maximum Response of Vibegron and Mirabegron for β3-Adrenergic Receptors

Brucker, Benjamin M; King, Jennifer; Mudd, Paul N; McHale, Kimberly
Background/UNASSIGNED:-adrenergic agonists vibegron and mirabegron have shown favorable safety profiles and efficacy for the treatment of overactive bladder. However, β-adrenergic receptors are also found outside the bladder, which could lead to off-target activity. Objective/UNASSIGNED:-adrenergic receptors. Methods/UNASSIGNED:, procaterol). Responses were quantified using homogeneous time-resolved fluorescence of cyclic adenosine monophosphate and were normalized to the respective control. Half-maximal effective concentration and maximum response values were determined by nonlinear least-squares regression analysis. Results/UNASSIGNED:-adrenergic activity was 2% and 15%, respectively. Conclusions/UNASSIGNED:response.
PMID: 35693456
ISSN: 0011-393x
CID: 5282472

Dorsal Onlay Oral Mucosa Graft Urethroplasty for Female Urethral Stricture

Richard, Claire; Peyronnet, Benoit; Drain, Alice; Rosenblum, Nirit; Hascoet, Juliette; Sussman, Rachael D; Freton, Lucas; Zhao, Lee C; Nitti, Victor W; Brucker, Benjamin M
OBJECTIVE:To describe and assess the outcomes of dorsal onlay oral mucosa graft urethroplasty for female urethral stricture. METHODS:We retrospectively reviewed the charts of all female patients who underwent dorsal onlay oral (buccal or lingual) mucosa urethroplasty for urethral stricture between 2011 and 2020 at two academic institutions. The primary endpoint was clinical success defined as any subjective improvement in LUTS self-assessed by the patients 1-3 months after catheter removal. Four surgeons performed the urethroplasties using a standardized technique: suprameatal incision, dissection and longitudinal opening of the dorsal aspect of the urethra, harvest of the oral mucosa graft, graft onlay sutured into the urethral opening. RESULTS:Nineteen patients were included. The clinical success rate was 94.7% at 1-3 months and 90.9% at 1 year. After a median follow-up of 12 months (range 1-49) there was one recurrence (5.3%), clinical success was achieved in 17 patients (89.5%) and both the maximum urinary flow rate and post void residual were significantly improved (15.2 vs 7.4 ml/s preoperatively; P = .008 and 71.5 vs 161.1 ml preoperatively; P = .001 respectively). The de novo stress urinary incontinence rate was 15.7% at 1-3 months and 9.1% at 1 year. CONCLUSION/CONCLUSIONS:Dorsal onlay oral mucosa graft urethroplasty for female urethral stricture appears feasible across multiple surgeons and is associated with a low perioperative morbidity, satisfactory functional outcomes and a low recurrence rate. Other series with larger sample size and longer follow-up are needed to confirm these findings.
PMID: 34537197
ISSN: 1527-9995
CID: 5061402

Evidence for the Appropriate Use of Telemedicine in Female Pelvic Medicine and Reconstructive Surgery

Barrett, Francesca; Stewart, Lauren E; Brucker, Benjamin M
Purpose of Review/UNASSIGNED:To summarize the available literature regarding telehealth interventions in the management of pelvic floor disorders. Recent Findings/UNASSIGNED:Most Female Pelvic Medicine and Reconstructive Surgery (FPMRS) patients own and feel comfortable operating the technology required to participate in telehealth interventions and would be willing to interact remotely with their providers. Telehealth may be an appropriate and effective tool for patient education about bladder and pelvic physiology and pathophysiology, remote pelvic floor muscle strengthening when in-person physical therapy is not accessible, overactive bladder follow-up and medication management, and for postoperative care following uncomplicated incontinence and prolapse surgery. Summary/UNASSIGNED:There is a growing body of literature specific to FPMRS supporting various telehealth interventions that could reasonably be expected to improve access to sub-specialty care while maintaining or improving healthcare quality and reducing costs to the patient and the healthcare system.
PMID: 34745407
ISSN: 1931-7212
CID: 5045952