The Evolving Story of Mesh Mid Urethral Slings: The Surgeon's Perspective.

PURPOSE: The objective of this study was to obtain the perspectives of surgeons who treat female stress urinary incontinence (SUI) and better understand their range of experiences with mesh mid urethral sling (MUS) surgery. MATERIALS AND METHODS: This qualitative study recruited gynecologic and urological surgeons who treat SUI. Surgeons were interviewed by phone and in person using a standardized interview guide. Interviews were transcribed, de-identified, and analyzed by 2 independent researchers. The transcripts were coded and summarized using the principles of thematic analysis. The research team came to consensus that a saturation of ideas representing a diverse demographic of surgeons had been achieved. RESULTS: Twenty-four interviews of surgeons from diverse geographic locations and practice types were performed. Many surgeons described MUS surgery as rewarding and favorably impactful for women with SUI, while others grappled with the serious risks associated with MUS surgery. Those who had treated women with life-altering pain after MUS recounted impactful patient stories. Many stated that recognition, acknowledgement, and appropriate referral of complications were fundamental to responsible and ethical care. Some surgeons expressed frustration and concern about the raised level of controversy and anxiety regarding the MUS landscape. All participants expressed that there was substantial room for improvement in multiple domains. Participants also shared their optimal strategies relevant to MUS surgery. CONCLUSIONS: Despite diverse views regarding the role of the MUS, there was agreement among surgeons that the surgeon-patient relationship, thorough informed consent and patient counseling, and accountability are essential when implanting MUSs.

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

INTRODUCTION: 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.

Management of Lower Urinary Tract Symptoms after Prostate Radiation.

PURPOSE OF REVIEW: To present urologists with guidance on how to approach and manage lower urinary tract symptoms (LUTS) in patients who have undergone radiation therapy (RT) for prostate cancer. RECENT FINDINGS: There are few studies that specifically examine treatment approaches for LUTS in patients who have undergone prostate cancer RT. LUTS after prostate RT are unique when compared to de novo LUTS. Understanding these distinctions is important for urologists' practice as well as patients' quality of life. Discussion of the risks and management of post-RT LUTS should be included in the shared decision-making process when counseling patients on various treatment options for prostate cancer. Further studies evaluating treatments for storage and voiding symptoms after RT are needed to help guide future care.

Single Institutional Experience with Single Stage Sacral Neuromodulation: Cost Savings and Outcomes in a Contemporary Case Series.

PURPOSE: Sacral neuromodulation is traditionally performed in 2 stages. Studies have projected that 1-stage sacral neuromodulation is cost-effective if the conversion rate is 61.3% or greater. To our knowledge we present the first case series in the literature to evaluate the cost of 1-stage sacral neuromodulation. The objective of our study was to evaluate outcomes and analyze cost using our institutional experience with 1-stage sacral neuromodulation. MATERIALS AND METHODS: A total of 15 consecutive 1-stage sacral neuromodulation procedures were performed at a self-insured, integrated health care institution. Cost data were determined using 2019 Medicare reimbursement rates for CPT codes 64581, 64585, 64590 and 64595. Median operative time was derived from actual institutional data. RESULTS: One-stage sacral neuromodulation implantation was performed in 15 patients. Median followup was 14.6 months (IQR 6.9-22.5). Of the 15 cases 14 (93.3%) were successful, defined as a 50% or greater improvement from baseline. Total reimbursement for the 15 patients who underwent 1-stage implantation was $329,430. If these patients had undergone traditional 2-stage implantation with equivalent outcomes, the overall reimbursement was determined to be $414,796. Single-stage sacral neuromodulation implantation provided a calculated total cost savings of $85,366 (p <0.01). Moreover, a projected 233 minutes in operative time was saved by performing 1-stage sacral neuromodulation (p <0.01). CONCLUSIONS: This study demonstrates the potential health care savings of a 1-stage sacral neuromodulation procedure. Moreover, 1-stage sacral neuromodulation may have other added benefits, such as reduced infection rates, patient satisfaction and other indirect cost savings, including reduced time off from work.

A Rapid Method to Preoperatively Assess Frailty for Older Patients with Pelvic Floor Conditions.

PURPOSE: Assessment of frailty can help surgeons predict perioperative risk and guide preoperative counseling. However, current methods are often cumbersome in the clinical setting. We prospectively compared the effectiveness of a rapid picture based Clinical Frailty Scale (CFS-9) assessed by patient and surgeon against reference standard Fried Frailty Index in older patients with pelvic floor conditions. MATERIALS AND METHODS: We enrolled 71 patients between March 2018 and June 2019. Frailty assessment using CFS-9 (scale ranging from very fit to terminally ill) was performed followed by the Fried Frailty Index, a validated tool of 5 measures (shrinking, physical energy, activity, grip strength, walking speed). Correlations and agreement between Fried Frailty Index and CFS-9 scores from the treating surgeon, a second surgeon (surgeon 2) and patient were analyzed using sensitivity, specificity, area under the curve and Cohen's Kappa. RESULTS: The patient cohort was mostly female (97.2%), with a mean age (±SD) of 73.0 (±5.9) years and 23.9% were frail using the Fried Frailty Index. Compared to the Fried Frailty Index, CFS-9 scores of the treating surgeon, surgeon 2 and patient had AUC values (95% CI) of 0.86 (0.77-0.86), 0.91 (0.84-0.91) and 0.88 (0.79-0.88), respectively. As assessed by Cohen's Kappa the CFS-9 scores all had substantial (surgeon 2, Kappa 0.66, 95% CI 0.46-0.85 or moderate (all other CFS-9 measures, Kappa 0.44 to 0.58) agreement with the Fried Frailty Index scores. CONCLUSIONS: Rapid and effective validated tools to screen for frailty are needed in the clinical setting. CFS-9 is an excellent predictor of frailty compared to the Fried Frailty Index for patients with pelvic floor conditions.

Treatment of urethral stricture disease in women: A multi-institutional collaborative project from the SUFU research network.

AIM: Female urethral stricture disease is rare and has several surgical approaches including endoscopic dilations (ENDO), urethroplasty with local vaginal tissue flap (ULT) or urethroplasty with free graft (UFG). This study aims to describe the contemporary management of female urethral stricture disease and to evaluate the outcomes of these three surgical approaches. METHODS: This is a multi-institutional, retrospective cohort study evaluating operative treatment for female urethral stricture. Surgeries were grouped into three categories: ENDO, ULT, and UFG. Time from surgery to stricture recurrence by surgery type was analyzed using a Kaplan-Meier time to event analysis. To adjust for confounders, a Cox proportional hazard model was fit for time to stricture recurrence. RESULTS: Two-hundred and ten patients met the inclusion criteria across 23 sites. Overall, 64% (n = 115/180) of women remained recurrence free at median follow-up of 14.6 months (IQR, 3-37). In unadjusted analysis, recurrence-free rates differed between surgery categories with 68% ENDO, 77% UFG and 83% ULT patients being recurrence free at 12 months. In the Cox model, recurrence rates also differed between surgery categories; women undergoing ULT and UFG having had 66% and 49% less risk of recurrence, respectively, compared to those undergoing ENDO. When comparing ULT to UFG directly, there was no significant difference of recurrence. CONCLUSION: This retrospective multi-institutional study of female urethral stricture demonstrates that patients undergoing endoscopic management have a higher risk of recurrence compared to those undergoing either urethroplasty with local flap or free graft.

I leaked, then I Reddit: experiences and insight shared on urinary incontinence by Reddit users.

INTRODUCTION AND HYPOTHESIS: Urinary incontinence (UI) is a highly prevalent condition, but is often not discussed owing to social stigma. Reddit is an internet platform for anonymous information sharing, expression, and discussion. We sought to qualitatively analyze people's behavioral, psychological, and illness experiences with UI expressed on Reddit to improve our understanding of patients' perceptions and ultimately the care we provide. METHODS: We used the Subreddit group "Incontinence" over 5 years and "BeyondtheBump" (postpartum forum) over 1 year as transcripts for qualitative analysis. Two independent researchers read and coded relevant threads (>100 posts and >400 comments). Charmaz's principles of grounded theory were applied. This included line-by-line coding of transcripts utilizing key phrases followed by grouping similarly coded phrases into preliminary themes. Emergent concepts were derived from these themes. RESULTS: A group of Reddit users with diverse UI etiologies were sampled. Qualitative analysis resulted in six preliminary themes. Users with UI were initially self-aware of their incontinence. They were interested in optimal product use. Users struggled with major life adjustments and relating to others. Nonetheless, they learned gradually to cope with their symptoms. Last, postpartum women specifically wanted additional immediate help for managing UI, often in the form of pelvic physiotherapy. Three emergent concepts were formed: the sense of isolation, acceptance over time, and self-drive to manage their UI. CONCLUSIONS: Internet forums such as Reddit may serve as a health resource for people with UI. Physicians can strive to better understand the patient perspective and their needs in order to provide optimal care.

Opioid Prescription and Use in Sacral Neuromodulation, Mid Urethral Sling and Pelvic Organ Prolapse Surgery: An Educational Intervention to Avoid Over Prescribing.

PURPOSE: The opioid problem has reached epidemic proportions and the prescription of opioids after surgery can lead to chronic use. We explored prescribing patterns and opioid use after 3 pelvic floor surgeries (sacral neuromodulation, prolapse repair and mid urethral sling) before and after an educational intervention to reduce opioid prescriptions. MATERIALS AND METHODS: We retrospectively reviewed the amount of opioid medication prescribed to patients who underwent these 3 types of surgeries at our institution from June 2016 to May 2017. A telephone survey of patients was done to quantify opioid use after surgery and satisfaction with pain control. Prescribing recommendations were established based on these results and an educational intervention for clinicians was performed. We then evaluated changes in opioid prescription and use during the 6 months following the intervention. A multiple regression model was used to identify factors associated with variability in opioid use. RESULTS: Our retrospective review showed that the 122 patients were prescribed 149%, 165% and 136% more mean morphine mg equivalents than were actually used for sacral neuromodulation, mid urethral sling and prolapse repair, respectively. After the educational intervention there was a significant reduction in morphine mg equivalents prescribed for all 3 surgeries in 78 patients (p <0.001). Diabetes (p = 0.001), a chronic pain condition (p = 0.017) and rectocele repair (p = 0.001) were associated with increased opioid use. CONCLUSIONS: Our data demonstrate that over prescription of opioids after pelvic floor surgery and a provider educational intervention resulted in a significant reduction in opioid prescribing without changing patient satisfaction with pain control.

Do Patients Discontinue Overactive Bladder Medications after Sacral Neuromodulation?

PURPOSE: Overactive bladder medications often have poor tolerability or lack of efficacy with many patients progressing to third line therapy such as sacral neuromodulation. Those treated with sacral neuromodulation may avoid the potential side effects of overactive bladder medications while achieving symptom improvement. We evaluated the postoperative rate of discontinuing overactive bladder medications in patients who underwent sacral neuromodulation of refractory overactive bladder. MATERIALS AND METHODS: We queried a prospectively collected, institutional review board approved database for patients who underwent sacral neuromodulation. Patients were excluded from analysis if the surgical indication was urinary retention or a sacral neuromodulation device was removed 1 year or less postoperatively. We assessed clinical characteristics, urodynamic parameters and filled overactive bladder medications using an external prescription database. Patient perceived postoperative outcomes were examined. Groups were compared by the Student t-test and the chi-square test. RESULTS: Of the 78 patients who met inclusion criteria 82.1% stopped and never restarted overactive bladder medications (the sacral neuromodulation only group). Of the patients 14.1% consecutively continued filling overactive bladder medications 1 year or more following surgery (the concurrent group). There was no difference between the groups in body mass index, gender, sacral neuromodulation revision, urodynamic parameters, the PGI-I (Patient Global Impression of Improvement) or patient perceived percent improvement. However, concurrent patients were significantly older than those who received sacral neuromodulation only (p = 0.002). CONCLUSIONS: More than 80% of patients who progressed to sacral neuromodulation discontinued overactive bladder medications and received sacral neuromodulation as the sole treatment. A small portion of patients concurrently used overactive bladder medications following sacral neuromodulation for 1 year or more. However, outcomes were similar in the 2 groups. Sacral neuromodulation is a strategy to provide a successful outcome in refractory cases and yet avoid the potentially detrimental side effects related to overactive bladder medications.

Incontinence after Prostate Treatment: AUA/SUFU Guideline.

PURPOSE: Urinary incontinence after prostate treatment (IPT) is one of the few urologic diseases that is iatrogenic, and, therefore, predictable and perhaps preventable. Evaluation of the incontinent patient, risk factors for IPT, the assessment of the patient prior to intervention, and a stepwise approach to management are covered in this guideline. Algorithms for patient evaluation, surgical management, and device failure are also provided. MATERIALS AND METHODS: This guideline was developed using a systematic review from the Mayo Clinic Evidence Based Practice Center with additional supplementation by the authors. A research librarian conducted searches from 2000 to December 21st, 2017 using Ovid, MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Databases of Systematic Reviews. Additional references through 12/31/2018 were identified. RESULTS: This guideline was developed by a multi-disciplinary panel to inform clinicians on the proper assessment of patients with IPT and the safe and effective management of the condition in both surgical and non-surgical contexts. Statements guiding the clinician on proper management of device failure are also included. CONCLUSION: Most patients who undergo radical prostatectomy (RP), and some patients who undergo radiation therapy (RT) or surgery for benign prostatic hyperplasia (BPH), will experience IPT. Although non-surgical options, such as pelvic floor muscle exercises (PFME), can hasten continence recovery, patients who remain incontinent at one-year post-procedure, or have severe incontinence at six months, may elect to undergo surgical treatment (e.g. artificial urinary sphincter). Prior to IPT surgery, the risks, benefits, alternatives, and additional likely procedures should be discussed with the patient.

Outcomes in a contemporary cohort undergoing sacral neuromodulation using optimized lead placement technique.

AIMS: To evaluate factors associated with progression to stage 2 sacral neuromodulation (SNM) for refractory overactive bladder, urinary retention, or fecal incontinence using optimal lead placement techniques with curved stylet. METHODS: This is a retrospective analysis of a prospectively collected database of all consecutive stage 1 SNM lead placements at our institution between August 2014 and May 2017 using optimal lead placement technique with curved stylet. Patients with refractory overactive bladder, urinary retention, or fecal incontinence were enrolled. Patients with 50% or more symptom improvement on voiding diaries were offered stage 2 implant. Demographics, clinical, and surgical characteristics were compared for patients who underwent successful stage 2 implants versus those who underwent lead removal at the end of the stage 1 trial period. RESULTS: 127 patients underwent SNM during the study period. Motor thresholds of ≤2 mA in all four electrodes were achieved in 74% of patients (94/127). A total of 89.0% (113/127) of patients received stage 2 implants. The main indication for implant, specifically urgency urinary incontinence, was positively associated with progression to stage 2 implant. Male gender, history of pelvic pain and previous SNM were negatively associated with progression to stage 2 implant. CONCLUSIONS: Our findings demonstrate that the contemporary optimized lead placement technique resulted in low motor thresholds and successful progression to stage 2 SNM implant in the majority of our cohort. Predictive factors associated with success or failure may potentially guide decision making for therapeutic interventions and counseling patient expectations.

Use of Third Line Therapy for Overactive Bladder in a Practice with Multiple Subspecialty Providers-Are We Doing Enough?

PURPOSE: Overactive bladder impacts more than 15% of the adult population. Compliance with medical treatment is low due to inadequate symptom control or intolerable side effects. Although third line therapies have improved the treatment of overactive bladder, many patients do not receive optimal treatment. We hypothesized that third line treatment use is higher among female pelvic medicine and reconstructive surgery urologists, and we examined its use at our tertiary referral center. MATERIALS AND METHODS: The electronic medical record was queried for patients with overactive bladder seen in 1 year. The number of visits associated with an overactive bladder prescription and the number of patients who received third line therapy were determined and subcategorized by department. Female pelvic medicine and reconstructive surgery providers were considered separately. RESULTS: A total of 5,445 patients (8,994 visits) were seen for overactive bladder. Of all patients seen for overactive bladder 3.5% received third line therapy compared with 10.0% and 14.1% of those seen by urology providers and female pelvic medicine and reconstructive surgery providers, respectively. CONCLUSIONS: The use of third line therapy was reported to be less than 5%. This rate is higher at our institution, which is likely due to multiple female pelvic medicine and reconstructive surgery providers. We also apply an algorithm that facilitates patient education on available options should first and second line treatments fail. Given the limited compliance with medical treatment for overactive bladder, we are likely missing a segment of the patient population who would benefit from third line treatment. Our data demonstrate an opportunity for urologists to improve the quality of overactive bladder treatment and subsequently improve patient quality of life.

Inconsistency in the Definition of Urinary Tract Infection after Intravesical Botulinum Toxin A Injection: A Systematic Review.

PURPOSE: To more accurately examine the rate of urinary tract infection following onabotulinumtoxinA injection of the bladder we systematically reviewed the literature for definitions of urinary tract infection in studies of onabotulinumtoxinA injections. We assessed the studies for consistency with guideline statements defining urinary tract infections. MATERIALS AND METHODS: We systematically reviewed the literature by querying MEDLINE® and Embase®. We included original studies on adult patients with idiopathic overactive bladder and/or neurogenic detrusor overactivity who underwent cystoscopy with onabotulinumtoxinA injection and in whom urinary tract infection was a reported outcome. RESULTS: We identified 299 publications, of which 50 met study inclusion criteria. In 27 studies (54%) urinary tract infection diagnostic criteria were defined with a total of 10 definitions among these studies. None of the overactive bladder studies used a definition which met the EAU (European Association of Urology) criteria for urinary tract infection. Only 2 of the 10 studies on patients with neurogenic bladder used a urinary tract infection definition consistent with the NIDRR (National Institute on Disability and Rehabilitation Research) standards. CONCLUSIONS: Definitions of urinary tract infection are heterogeneous and frequently absent in the literature on onabotulinumtoxinA to treat overactive bladder and/or neurogenic bladder. Given the potential for post-procedure urinary symptoms in this setting, explicit criteria are imperative to establish the true urinary tract infection rate following treatment with onabotulinumtoxinA.

Indications for Augmentation Cystoplasty in the Era of OnabotulinumtoxinA.

Overactive bladder (OAB) with or without a neurogenic etiology that is refractory to conventional first-, second-, and third-line therapies is a challenging condition that typically leaves the physician and the patient with few options. Historically, treatment for patients who did not respond to any of the few pharmacologic choices focused on more invasive surgical options--specifically, augmentation cystoplasty (AC). In 2011 and 2013, the Food and Drug Administration (FDA) approved intradetrusor injection of onabotulinumtoxinA for the treatment of neurogenic detrusor overactivity (NDO) and idiopathic detrusor overactivity (IDO), respectively. Since then, a dramatic decline in the use of AC has called into question its utility in the treatment algorithm of this difficult patient population. The purpose of this paper is to review the current body of literature in order to outline the circumstances in which AC is still a relevant therapeutic option.

Management of nocturia in the female.

Nocturia is a common but overlooked lower urinary tract symptom that substantially reduces patient health and quality of life. Though traditionally viewed as occurring predominantly in males, nocturia has been found to be equally as prevalent in females. The recent emphasis on the importance of nocturia has resulted in a surge of research studies, providing a foundation for current and future management decisions. In this review, we describe the current recommendations for the female patient in light of the most recently published studies, including a unique interest in predicting treatment response.

Oxybutynin-associated Cognitive Impairment: Evidence and Implications for Overactive Bladder Treatment.

Anticholinergic medications have long been a mainstay of overactive bladder (OAB) treatment. Oxybutynin, a first-generation anticholinergic, still accounts for more than half of all OAB medication prescriptions, despite associations with impaired memory and cognition, as well as mounting evidence that it may increase the risk of incident dementia. This review details the current literature regarding oxybutynin and cognition, including evidence from preclinical, clinical, and real-world studies that show that oxybutynin binds nonspecifically to muscarinic receptors in the brain and is associated with adverse cognitive outcomes. We also discuss society recommendations to reduce use of oxybutynin and other anticholinergics to treat OAB.

Robotic-Assisted Laparoscopic Removal of Mid-Urethral Mesh Slings Eroded into the Bladder.

INTRODUCTION AND OBJECTIVES: Depending on the indication, there are multiple surgical approaches for the removal of mid-urethral mesh slings (MUS): transvaginal, endoscopic, open abdominal, and robotic. We demonstrate the robotic approach to treat MUS that have eroded into the bladder. The robotic approach offers excellent exposure, visualization, and accessibility. Compared to endoscopic approaches, the entire arm of the sling can be removed from the bladder wall, the bladder repaired, and the foreign body completely eliminated. Robotic MUS excision is ideal in patients who would be best served by maximal removal of the mesh from the bladder to prevent future complications. METHODS: In this video, we display 2 different cases showing 2 unique approaches to robotic MUS excision depending on the location of mesh erosion: 1. If a retropubic sling is eroded through the anterior bladder, we begin by dropping the bladder and entering the space of Retzius to locate the mesh arm. 2. If the sling is eroded into the posterior bladder, a cystotomy is made on the anterior dome to visualize the posterior bladder wall. RESULTS: Once the mesh is identified, we follow the mesh graft carefully and dissect it away from surrounding tissues. The dissection is immediately close to the mesh, without fragmenting it, to allow for complete excision and protection of adjacent critical structures. The surgical principles and instrument techniques of robotic mesh excision mirror those utilized for transvaginal mesh excision. Complications of this surgical approach include a urinary leak that may require prolonged catheterization or re-operation and recurrent stress urinary incontinence, in addition to typical operative risks. CONCLUSION: For treatment of mesh erosion into the bladder, a robotic approach offers excellent visualization, is feasible, and well-tolerated. Compared to fragmenting the mesh using an endoscopic approach, the robotic approach has the advantage of excising the mesh definitively and preventing future recurrences of mesh erosion. Properly selected patients should be offered the robotic approach to mesh excision.

Long-term follow-up of polypropylene bone anchored slings.

INTRODUCTION: The transvaginal bone anchored polypropylene sling (BAS) has proven to be a successful treatment for patients with SUI. However, there is limited data on long-term outcomes following BAS with polypropylene mesh. We report our series of patients who had at least 3 years of follow-up after placement of BAS. MATERIALS AND METHODS: A retrospective review of prospectively collected data of patients undergoing BAS for stress urinary incontinence (SUI) with minimum 3 year follow-up was performed. Outcomes and complications were determined from annual mailed post-operative questionnaires. RESULTS: 142 patients who had undergone BAS and had answered post-operative questionnaires at a minimum of 3 years were identified. Average follow-up was 58 months (range 36-97 months). The overall success rate was 71 % with a dry rate of 27 %. Complications occurred in 9 % of patients, more commonly in patients without a history of anti-incontinence procedure. CONCLUSIONS: Although less commonly used, BAS with polypropylene mesh is associated with an acceptable success rate at long term follow-up but a low completely dry rate.

A Plain Language Summary on the Effect of the Medication Vibegron on Blood Pressure and Heart Rate in People With Overactive Bladder.

WHAT IS THIS SUMMARY ABOUT?: This is a plain language summary of an article originally published in the journal Blood Pressure Monitoring. Vibegron is a medicine that was approved by the US Food and Drug Administration (also called FDA) in 2020 for treatment of overactive bladder, a condition that causes a frequent and urgent need to urinate. This study took place before the medicine was approved to look at whether vibegron affects blood pressure or heart rate. WHAT WERE THE RESULTS?: A total of 214 patients with overactive bladder took part in the study. 108 patients took vibegron for 28 days, and 106 took placebo for 28 days. A placebo is a pill with no medicine in it. Their blood pressure was measured on the first day and the last day. A meaningful increase in blood pressure is when a patient's average blood pressure measurements changed by 3.5 mmHg or more. Patients with overactive bladder who took a 75 mg dose of vibegron once daily had no meaningful increase in blood pressure or heart rate. This included people who were already taking medication for their high blood pressure. WHAT DO THE RESULTS MEAN?: This study suggests that patients can use vibegron without concern that it may meaningfully raise blood pressure or heart rate.

Anterior pelvic organ prolapse repair using synthetic mesh.

Since the U.S. Food and Drug Administration (FDA) statement on mesh in July of 2011, there has been controversy regarding synthetic mesh repairs for vaginal prolapse. In this article, we review the biochemical basis for the use of synthetic mesh in prolapse repair as well as clinical results of anterior compartment prolapse repair with synthetic mesh. Finally, we discuss the FDA warning regarding mesh.