The Role of Vibrators in Women's Pelvic Health: An Alluring Tool to Improve Physical, Sexual, and Mental Health.

INTRODUCTION AND HYPOTHESIS: In limited studies vibrators have been shown to improve sexual function and pelvic floor health; however, there are even fewer studies on the effect of vibrator use on overall genitourinary and mental health. To investigate the effect of regular vibrator use on sexual, genitourinary, and mental health in addition to quality of life. METHODS: We performed a prospective pilot study of women aged 18 to 80 years recruited from a urogynecology clinic. Study participants were instructed to use a vibrator according to the protocol. Sexual function, pelvic floor function, mental health, and pelvic examination were assessed at the initial visit and at 3 months' follow-up using validated questionnaires. RESULTS: Of the 79 participants enrolled in the study, 53 women (66%) completed the study. The mean age of the participants was 54.7 years (range 19-80 years), and the majority of participants were white (n = 59, 74.7%), post-menopausal (n = 48, 60.8%), and not receiving systemic (n = 63, 79.7%) or local (n = 63, 79.7%) hormone therapy. Sexual function significantly improved over time (p = 0.002), whereas the rate of bothersome pelvic organ prolapse symptoms and pain scores significantly decreased (p = 0.034 and 0.0008 respectively). Rates of urge urinary incontinence decreased although this was not statistically significant (p = 0.059). There was a significant improvement in the gross appearance of lichen sclerosus lesions (p = 0.025) and in the severity of vaginal atrophy (p = 0.018). Rates of depression were significantly decreased (p = 0.011). CONCLUSIONS: Vibrator use was associated with improved sexual, genitourinary, and mental health.

Can vaginal lactobacillus suppositories help reduce urinary tract infections?

INTRODUCTION AND HYPOTHESIS: Recurrent urinary tract infections (rUTIs) are a burden to patients and the health care economy. Vaginal probiotics and supplements have gained significant attention in mainstream media and lay press as a non-antibiotic alternative. We performed a systematic review to determine whether vaginal probiotics are an effective means of prophylaxis for rUTI. METHODS: A PubMed/MEDLINE article search was performed from inception to August 2022 for prospective, in vivo use of vaginal suppositories for the prevention of rUTIs. Search terms included: vaginal probiotic suppository (34 results), vaginal probiotic randomized (184 results), vaginal probiotic prevention (441 results), vaginal probiotic UTI (21 results), and vaginal probiotic urinary tract infection (91 results). A total of 771 article titles and abstracts were screened. RESULTS: A total of 8 articles fit the inclusion criteria and were reviewed and summarized. Four were randomized controlled trials, with 3 of the studies having a placebo arm. Three were prospective cohort studies, and 1 was a single arm, open label trial. Five of the 7 articles that specifically evaluated for rUTI reduction with vaginal suppositories did find a decreased incidence with probiotic use; however, only 2 had statistically significant results. Both of these were studies of Lactobacillus crispatus and were not randomized. Three studies demonstrated the efficacy and safety of Lactobacillus as a vaginal suppository. CONCLUSION: Current data support the use of vaginal suppositories containing Lactobacillus as a safe, non-antibiotic measure, but actual reduction of rUTI in susceptible women remains inconclusive. The appropriate dosing and duration of therapy remain unknown.

Defining Properly Collected Urine: Thresholds to Improve the Accuracy of Urinalysis for Microscopic Hematuria Evaluation in Women.

PURPOSE: Microscopic hematuria is one of the most common office consults for urologists. While revised guidelines have risk-stratified patients to reduce unnecessary screening, they do not provide guidance concerning specimen quality. We sought to define "properly collected" specimens using catheterized urine samples as a reference to improve the utility of hematuria screening in women. MATERIALS AND METHODS: We prospectively acquired same-visit voided and catheterized urine samples from 46 women referred for microscopic hematuria from September 2016 to March 2020. Characteristics of pre-referral urinalysis were compared to the matched specimens. True microscopic hematuria was defined as ≥3 red blood cells per high power field on catheterization. RESULTS: Catheterized urinalyses had significantly fewer red blood and squamous epithelial cells in comparison to both referral urinalyses (p=0.006, p=0.001, respectively) and same-day void urinalyses (p=0.02, p=0.04, respectively). As no catheterized sample had >2 squamous epithelial cells, we applied this squamous epithelial cell threshold to referral urinalyses for analysis. Addition of this criterion for "properly collected specimen" increased the positive predictive value of referral urinalyses from 46.1% to 68.8% for true microscopic hematuria. Fewer than 2 squamous epithelial cells with elevated RBC was a significant predictor for true microscopic hematuria (p=0.003). CONCLUSIONS: Voided specimens in the urology clinic had significantly lower red blood cells than referral samples, indicating improved collection technique may reduce false positive urinalyses. Matched collection suggested that repeat collection by catheterization in women who present with >2 squamous epithelial cells per high power field on referral urinalysis may prevent unnecessary future work-up.

A Human Factors Approach to Vaginal Retained Foreign Objects.

STUDY OBJECTIVE: This study aimed to apply a structured human factors analysis to understand conditions contributing to vaginal retained foreign objects (RFOs). DESIGN: All potential vaginal RFO events from January 1, 2000, to May 21, 2019, were analyzed by trained human factors researchers. Each narrative was reviewed to identify contributing factors, classified using the Human Factors Analysis and Classification System for Healthcare. SETTING: An 890-bed, academic medical center in Southern California. PATIENTS: Patients who underwent a vaginal procedure in which a vaginal RFO-related event occurred were included in this study. However, no patient information was included, and only the relevant details from their procedures were included. INTERVENTIONS: No interventions were developed or implemented. MEASUREMENTS AND MAIN RESULTS: Over the 19-year period, 45 events were reported. The most common items were vaginal packing and vaginal sponges (53.33%). Less frequently retained items involved broken instruments (20.20%). Most cases were laparoscopic hysterectomies or vaginal deliveries. Based on the Human Factors Analysis and Classification System, 75 contributing factors were identified, consisting primarily of preconditions for unsafe acts (communication challenges, coordination breakdowns and issues with the design of tools/technology) and unsafe acts (errors). CONCLUSION: Although rare, vaginal RFOs do occur. The top 2 contributing factors were skill-based errors and communication breakdowns. Both types of errors can be addressed and improved with human factors interventions, including simulation, teamwork training, and streamlining workflow to reduce the opportunity for errors.

Mycoplasma and Ureaplasma Molecular Testing Does Not Correlate with Irritative or Painful Lower Urinary Tract Symptoms.

PURPOSE: For patients with persistent irritative lower urinary tract symptoms, such as dysuria and urinary frequency, evaluation for the atypical organisms Ureaplasma and Mycoplasma has been a common part of care. However, these species are genitourinary colonizers and have not been established as causative pathogens in chronic lower urinary tract symptoms. We therefore sought to evaluate diagnostic testing patterns for Ureaplasma and Mycoplasma and characterize the associations of these bacteria with irritative lower urinary tract symptoms using molecular detection techniques. MATERIALS AND METHODS: Ureaplasma/Mycoplasma testing patterns for 2019 were assessed using an anonymized data repository. Clean catch urine specimens (179) were collected prospectively from female and male patients with and without irritative lower urinary tract symptoms. Quantitative polymerase chain reaction evaluated urinary Ureaplasma and Mycoplasma DNA concentrations, while next-generation sequencing assessed the relative abundance of Ureaplasma and Mycoplasma within the urinary bacterial population. RESULTS: Ureaplasma/Mycoplasma testing was common, with 575 tests performed in 2019 in our community hospital system. In our cohort, Ureaplasma and Mycoplasma were identified in similar proportions in symptomatic and asymptomatic subjects: 25% of female controls and 27% of females with lower urinary tract symptoms and 9.5% of asymptomatic males and 3.3% of men with symptoms (p=0.87 and p=0.91 for females and males, respectively). Regression analysis revealed that both abundance and concentrations of Mycoplasmataceae correlated negatively with a range of irritative lower urinary tract symptoms, including dysuria and urethral pain. CONCLUSIONS: A statistically significant negative correlation of Ureaplasma/Mycoplasma levels with a variety of lower urinary tract symptoms suggests that polymerase chain reaction-based Mycoplasmataceae detection has little diagnostic benefit in assessment of chronic irritative urinary symptoms.

Economic evaluation of elective cesarean versus vaginal delivery on cost of future pelvic floor disorders in the United States.

AIM: To analyze the cost impact of cesarean versus vaginal delivery in the United States on the development of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). METHODS: We compared average cost of delivery method to the lifetime risk and cost of pelvic floor disorders (PFDs) in women < 65 years. Costs of maternal care, obtained from the MarketScan® database, included those incurred at delivery and 3 months post-partum. Future costs of PFDs included those incurred after delivery up to 65 years. Previously reported data on the prevalence of POP and SUI following cesarean and vaginal delivery was used to calculate attributable risk. An incremental cost of illness model was used to estimate costs for SUI. Direct surgical and ambulatory care costs were used to determine cost of POP. RESULTS: Average estimated cost was $7089 for vaginal delivery and $9905 for cesarean delivery. The absolute risks for SUI and POP were estimated as 7% and 5%, respectively, following cesarean delivery, and 13% and 14%, respectively, following vaginal delivery. For SUI, average direct cost was $5642, indirect cost was $4208, and personal cost was $750. Average direct cost of POP surgery was $4658, and nonsurgical cost was $2220. The potential savings for reduced prevalence of SUI and POP in women who underwent cesarean delivery is estimated at $1255, but they incur an additional $2816 maternal care cost over vaginal delivery. CONCLUSIONS: Although elective cesarean is associated with reduced prevalence of PFDs, the increased initial cost of cesarean delivery does not offset future cost savings.

Prospective study of a single-incision sling versus a transobturator sling in women with stress urinary incontinence: 3-year results.

BACKGROUND: Long-term safety and efficacy data on use of single-incision slings in stress urinary incontinence are limited. OBJECTIVE: To determine whether the single-incision sling Solyx (Boston Scientific, Marlborough, MA) is noninferior to the transobturator sling Obtryx II (Boston Scientific) in efficacy and safety for treatment of stress urinary incontinence. This 522 post-market surveillance study has been designed in response to a Food and Drug Administration request to evaluate improvement in stress urinary incontinence at 36 months following single-incision sling compared with baseline, as well as provide an assessment of mesh-related complications and subject-reported outcomes, relative to the transobturator sling control. STUDY DESIGN: This prospective, nonrandomized, parallel cohort, multicenter postapproval study enrolled subjects to receive single-incision sling or transobturator sling. Study sites were assigned to a cohort group based on documented competency with the cohort device. Patient follow-up was 36 months to compare efficacy and adverse events for noninferiority. Inclusion criteria included stress predominant urinary incontinence, a positive cough stress test, and post-void residual ≤150 cc. Participants were ineligible if they had undergone previous stress urinary incontinence surgery or had a previous mesh complication. Primary endpoint was treatment success defined by composite negative cough stress test and subjective improvement in stress urinary incontinence using Patient Global Impression of Improvement at 36 months. Secondary endpoints included adverse events and indications for retreatment. Noninferiority margins of 15% and 10% were prespecified for the primary efficacy and safety endpoints. Data analysis was performed using intent-to-treat and per-protocol methods. Due to the observational nature of the study, a propensity score methodology was applied to account for differences in patient and surgeon characteristics between treatment groups. The study design and variables to be included in the propensity score model were reviewed and approved by Food and Drug Administration reviewers before outcome analyses were performed. RESULTS: No evidence of imbalance in baseline characteristics was observed between groups after propensity score stratification in the 281 subjects. EBL (72.3±92 vs 73.1±63.9 mL, P=.786), time to spontaneous void (1.1±2 vs 0.8±2.8 days, P=.998), and time to discharge (0.7±0.7 vs 0.6±0.6 days, P=.524) were similar between groups. At 36 months, treatment success was 90.4% in the single-incision sling group and 88.9% in the transobturator sling group (P=.93). At 36 months, mesh-related complications were similar between groups (mesh exposure: 2.8% vs 5.0%, P=.38). Serious adverse events including pain during intercourse (0.7% vs 0%, P=1.00), pelvic pain (0.7% vs 0%, P=1.00), and urinary retention (2.8% vs 4.3%, P=.54) were similar between groups. CONCLUSION: Single-incision sling was not inferior to transobturator sling for long-term treatment success of stress urinary incontinence. The rates of serious adverse events were acceptably low and similar between groups.

Writing in the Margins of Sexual Function Questionnaires: A Qualitative Analysis of Data From Women With Pelvic Floor Disorders.

BACKGROUND: The impact of pelvic floor disorders (PFDs) on female sexual function is not well understood, partly due to difficulties in measurement and evaluation. AIM: We sought to assess how women with PFDs respond to sexual function questionnaires through an analysis of survey marginalia, or the comments written in the margins of fixed-choice surveys. METHODS: 94 women with PFDs completed validated written sexual function questionnaires (Global Study of Sexual Attitudes and Behaviors survey, Female Sexual Function Index, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecological Association-Revised). Marginalia, or the additions, eliminations, and changes subjects made (by hand) to survey items, were collected. Data were coded and analyzed qualitatively using grounded theory methodology. OUTCOMES: Themes and emergent concepts related to the content of survey marginalia were the primary outcomes of this study. RESULTS: We observed 177 instances of marginalia across all questionnaires. Qualitative analysis revealed 7 preliminary themes and 2 emergent concepts. Preliminary themes included partner-related topics, loss, problems during intercourse, emotional problems, other medical problems, and survey answer choices failing to capture the spectrum of patient experiences. Emergent concepts revealed highly diverse sexual function in this population and a wide range of factors that influence sexual function. CLINICAL IMPLICATIONS: Conducting qualitative studies alongside sexual function questionnaires can allow for a more meaningful assessment of the sexual function of women with various underlying conditions, such as PFDs. STRENGTHS & LIMITATIONS: This is the first study of its kind to analyze survey marginalia from sexual function questionnaires among women with PFDs. The limitations of this study include the inherently spontaneous nature of marginalia data. In addition, the ways in which study participants responded to sexual function questionnaires in our study may not be reflective of all potential subjects. CONCLUSION: Analysis of survey marginalia from sexual function questionnaires amongst women with PFDs revealed new information regarding patients' histories, concerns, and thoughts. Over half of the women in this study felt the need to expand, explain, or eliminate responses from the questionnaires. Many subjects were no longer sexually active, which accounted for a large majority of participants leaving questions blank or responding with "N/A." Standard sexual evaluation tools may fail to capture the complexity, spectrum, and depth and breadth of patient experiences. Parameshwar PS, Borok J, Jung E, et al. Writing in the Margins of Sexual Function Questionnaires: A Qualitative Analysis of Data From Women With Pelvic Floor Disorders. J Sex Med 2020;17:1705-1714.

Re-evaluation of birth trends and pregnancy complications among female urologists: Have we made any progress?

AIMS: Females are becoming surgeons at ever-increasing rates and doing so while many have or wish to have children. This study follows up on a 2007 effort to study the problems and conditions such women faced. We ask here if these challenges are different after a decade that included changes in working rules. METHODS: A survey was sent to all female American Board of Urology diplomates. Birth trends, pregnancy complications, infertility service requirements, and satisfaction were evaluated in respondents (n = 183) and compared to the previous survey of female urologists who completed residency before August 2007 as well as Center for Disease Control data. RESULTS: Seventy-six physicians completed the survey who were residents before 2007, while 107 replied who experienced residency after. The first group's average age was 50.2 and the second's 38.3. Overall, these women gave birth 6 to 7 years later than the US mean. Complications did not decrease, infertility occurred at similar levels, and both were higher than US norms. Length of maternity leave correlated with respondents' level of overall satisfaction. The most positive responses came from those with more than 8 weeks off (P = .002). CONCLUSIONS: Women practicing in urology gave birth later, had greater fertility issues, used assisted reproductive technology (ART) more and reported a higher level of at least one complication during pregnancy than American women overall. Changes in hours and awareness of this issue have not made giving birth a healthier event for these physicians. Further investigation into factors other than work hours is needed.

Symptomatic overlap in overactive bladder and interstitial cystitis/bladder pain syndrome: development of a new algorithm.

OBJECTIVES: To address challenges in the diagnosis and classification of storage lower urinary tract symptoms (LUTS), we sought to define the fundamental features of overactive bladder (OAB) and interstitial cystitis/bladder pain syndrome (IC/BPS), two conditions with considerable symptomatic overlap. Through retrospective comparison of self-reported symptoms in women with a range of clinical presentations and symptom severities, we have attempted to refine the diagnostic features of OAB and IC/BPS and to develop a novel clinical nomogram to improve patient screening and classification. MATERIALS AND METHODS: We performed a univariate analysis comparing responses to the female Genitourinary Pain Index (fGUPI), the OAB Questionnaire and O'Leary-Sant Indices (the Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index) in an initial cohort of 50 patients with OAB, patients with IC/BPS and control subjects. Only eight questions differed significantly between the IC/BPS and OAB groups; we used five unique questions and three measuring bother to generate a novel composite scoring system and nomogram that included urgency incontinence, bladder pain and symptomatic bother domains to differentiate these populations, which was validated in a second cohort of 150 patients. The addition of a self-reported bother index resulted in the creation of a diagnostic algorithm to identify and classify LUTS clusters across the total population. RESULTS: While all validated questionnaires could distinguish between controls and patients with storage LUTS, no combined symptom scores differed significantly between the IC/BPS and OAB groups. These results are reflective of the prevalence of significant bladder pain (35%) in patients with OAB and the presence of urge incontinence (25%) in patients with IC/BPS. Only the fGUPI pain domain scores differed between patients in the OAB and IC/BPS groups, but it was not accurate enough for diagnostic evaluation (68% accuracy). Our composite scores and nomogram gave a much-improved diagnostic accuracy (94%) and demonstrated utility as a screening tool to identify storage LUTS in patients presenting for unrelated complaints, e.g. microhaematuria. CONCLUSIONS: There is significant overlap of urinary tract symptoms between OAB and IC/BPS. We present a novel algorithm that provides a binary output capable of guiding clinical diagnosis. Future studies aimed at assessing the diagnostic value of novel classification schemes that address symptoms rather than specific diagnoses may improve patient prognosis.

Comparative effectiveness of one versus two-stage sacral neurostimulation device placement.

OBJECTIVE: Sacral neurostimulation (SNS) is an effective third-line treatment for overactive bladder. We sought to compare the cost of standard two-stage SNS device placement to that of a combined one-stage placement using a Markov chain model. METHODS: Costs were defined using Medicare outpatient reimbursement rates. The model was developed as follows: With the two-stage approach, patients underwent initial lead placement with fluoroscopy and those who converted to stage two underwent permanent generator placement week later. Patients who did not convert underwent lead removal. Patients undergoing a one-stage procedure had initial lead and generator placement at the same time. Patients with success underwent no further procedure. Patients without success could opt for generator and lead removal. Cost effectiveness of one versus two-stage placement depended on successful conversion rate. RESULTS: Reimbursement included physician, anesthesia, facility and device fees. In a two-stage procedure, initial cost of lead placement was $6170. With successful conversion, cost of a second procedure with permanent lead and generator placement was $18,474. Patients who failed test phase underwent lead removal for a cost of $2879. In a one-stage procedure approach, initial cost of permanent lead and generator placement was $18,474. Patients with a successful outcome had no additional costs. Patients with an unsuccessful outcome could have the lead and generator removal for a cost of $5758. If the conversion rate from testing phase to permanent placement was greater than 71%, a one-stage approach proved to be cost effective. CONCLUSIONS: Identifying patients with favorable risk factors for success may predict those patients who warrant a one-stage approach.

What is the ideal antibiotic prophylaxis for intravesically administered Botox injection? A comparison of two different regimens.

INTRODUCTION: Onabotulinum toxin A (Botox®) administered intravescially is an effective treatment for idiopathic detrusor overactivity, of which urinary tract infections (UTIs) are a common complication. The purpose of this study was to compare two prophylactic antibiotic regimens with the goal of decreasing UTI rates following intravesically administered Botox® injection. MATERIALS AND METHODS: A retrospective review of two groups of patients undergoing intravesically administered Botox® injections was performed-one with idiopathic and one with neurogenic detrusor overactivity. One group received a dose of ceftriaxone intramuscularly (IM) at the time of Botox® injection, and a second group received a 3-day course of a fluoroquinolone orally starting the day before the procedure. The rate of postprocedure UTI was examined using a χ2 test. A secondary analysis was performed using logistic regression modeling to test the association between clinical characteristics and antibiotic regimen and risk of postprocedure UTIs. RESULTS: Botox® injections were performed on 284 patients: 236 received a single dose of ceftriaxone IM and 48 received 3 days of a fluoroquinolone orally. The UTI rate was significantly lower in the fluoroquinolone group (20.8%) vs. the cephalosporin group (36%), p = 0.04. Predictors of postprocedure UTIs included single dose of antibiotics IM [odds ratio (OR 2.80, p = 0.02] and a positive preprocedure urine culture (OR 1.31, p = 0.03). CONCLUSIONS: We found a significantly lower rate of UTIs when patients received a 3-day course of a fluoroquinolone orally as opposed to a single dose of a third-generation cephalosporin IM. Patients with a positive preprocedure culture might benefit from an even longer duration of antibiotics at the time of Botox® injection.

Flow disruptions in robotic-assisted abdominal sacrocolpopexy: does robotic surgery introduce unforeseen challenges for gynecologic surgeons?

INTRODUCTION AND HYPOTHESIS: The purpose of this study was to apply a human factors research approach to identify flow disruptions, deviations in the optimal course of care, in robotic abdominal sacrocolpopexy procedures with the ultimate goal of developing system interventions to improve the safety and efficiency of robotic surgery. METHODS: Twenty-four robotic abdominal sacrocolpopexy procedures were observed for flow disruptions. Surgeries were divided into four phases: (1) patient arrival and induction of anesthesia; (2) port placement and robot docking; (3) console time; (4) undocking of robot, incision closure, and patient exiting the OR. RESULTS: Flow disruptions were observed at a rate of 10.9 ± 5.1 per hour. The most frequently observed flow disruptions involved training issues (2.8 ± 2.4 flow disruptions per hour), equipment (2.2 ± 1.6 flow disruptions per hour), and poor coordination (2.0 ± 1.3 flow disruptions per hour). The rate of flow disruptions was highest in phase 2 (19.2 ± 14.4 flow disruptions per hour). Cases with more experienced surgeons involved shorter console times by 1.5 h (95% CI: 0.1, 3.0, p = 0.033) and 1.8 fewer (95% CI: 1.2, 2.6, p = 0.001) flow disruptions per hour. Surgeries were 1 h shorter on average (95% CI: 0.1, 1.9, p = 0.034) in cases in which the patient was > 65 years old. Da Vinci S console times were 0.8 h longer (95% CI: 0.01, 1.5, p = 0.047) than Si. CONCLUSIONS: Flow disruptions in robotic abdominal sacrocolpopexy surgery occur about every 6 min. Flow disruption rates are highest during the most complex portions of the surgery. More experienced surgeons have lower flow disruption rates and operate more quickly.

Is it Safe to Reduce Water Intake in the Overactive Bladder Population? A Systematic Review.

PURPOSE: Overactive bladder imposes a significant socioeconomic burden on the health care system. It is a commonly held belief that increased fluid intake (8 glasses of water per day) is beneficial for health. However, increased fluid intake exacerbates overactive bladder symptoms. Thus, it is imperative that clinicians appropriately educate patients for whom increased water intake may be detrimental (women with overactive bladder), in contrast to patients with comorbidities that necessitate increased water intake (nephrolithiasis). We systematically reviewed the literature to determine the potential health advantages of increased water intake and identify specific subpopulations that need increased hydration. MATERIALS AND METHODS: We systematically reviewed published articles from 1972 through 2017 on PubMed® and the Cochrane Library. The data were reviewed independently by 2 individuals. Studies were included if they explored water intake in relation to the risk of a particular disease. RESULTS: Level 1 evidence supported increased fluid intake in patients with nephrolithiasis. There was no available evidence to support increased fluid intake in patients with cardiovascular disease, constipation, venous thromboembolism, headaches, cognitive function or bladder cancer. Dehydration may exacerbate some conditions, specifically chronic constipation and headache intensity. Increased fluid intake may have a role in preventing stroke recurrence but not in preventing primary stroke. CONCLUSIONS: The available reviewed literature suggests no benefit to drinking 8 glasses of water per day in patients without nephrolithiasis. Also, excess fluid intake can exacerbate symptoms of overactive bladder.

What is the true catheterization rate after intravesical onabotulinumtoxinA injection?

INTRODUCTION AND HYPOTHESIS: A known side effect of intravesical onabotulinumtoxinA (Botox®) injection for overactive bladder (OAB) is urinary retention requiring clean intermittent catheterization (CIC), the fear of which deters patients from choosing this therapy. In clinical practice, patients with an elevated postvoid residual (PVR) are often managed by observation only, providing they do not have subjective complaints or contraindications. We sought to determine the true rate of urinary retention requiring CIC in clinical practice. METHODS: A retrospective review was performed over a 3-year period of patients who received 100 units of intravesical onabotulinumtoxinA for the treatment of OAB. Patients were seen 2 weeks after the procedure to measure PVR. CIC was initiated in patients with a PVR ≥350 ml and in those with subjective voiding difficulty or acute retention. RESULTS: A total of 187 injections were performed on 99 female patients. CIC was required following three injections (1.6%): for acute retention in two patients and subjective voiding difficulty in one patient with a PVR of 353 ml. Following 12 injections, the patient had a PVR of ≥350 ml, and following 29 injections, the patient had a PVR of >200 but <350 ml without symptoms. CIC was not initiated in these 41 patients. None of these patients experienced subsequent retention, and all showed resolution of their elevated PVR within 8 weeks. CONCLUSIONS: In our series of 187 intravesical injections for OAB, the rate of postprocedure urinary retention requiring catheterization was only 1.6%. This low rate can be attributed to less rigorous criteria for CIC initiation than those applied in previous studies. While important to counsel patients on the risk of retention, patients can be reassured that the actual rate of CIC is low.

Challenging the Myth: Transvaginal Mesh is Not Associated with Carcinogenesis.

PURPOSE: We sought to determine if there was a potential link between synthetic polypropylene mesh implantation for transvaginal pelvic organ prolapse and stress urinary incontinence, and carcinogenesis using statewide administrative data. MATERIALS AND METHODS: Women who underwent transvaginal surgery for pelvic organ prolapse or stress urinary incontinence with mesh between January 2008 and December 2009 in New York State were identified using ICD-9-CM procedure codes and CPT-4 codes. Patients in the mesh cohort were individually matched to 2 control cohorts based on comorbidities and procedure date. Carcinogenesis was determined before and after matching at 1, 2 and 3 years, and during the entire followup time. RESULTS: A total of 2,229 patients who underwent mesh based pelvic organ prolapse surgery and 10,401 who underwent sling surgery for stress urinary incontinence between January 2008 and December 2009 were included in the study. Mean followup was 6 years (range 5 to 7). Exact matching between the mesh and control cohorts resulted in 1,870 pairs for pelvic organ prolapse mesh and cholecystectomy (1:2), 1,278 pairs for pelvic organ prolapse mesh and hysterectomy (1:1), 7,986 pairs for sling and cholecystectomy (1:1) and 3,810 pairs for sling and hysterectomy (1:1). Transvaginal mesh implantation was not associated with an increased risk of a cancer diagnosis (pelvic/local cancers or any cancer) at 1 year and during the entire followup of up to 7 years. CONCLUSIONS: Transvaginal surgery with implantation of mesh was not associated with the development of malignancy at a mean followup of 6 years.

Is vaginal mesh a stimulus of autoimmune disease?

BACKGROUND: Polypropylene mesh has been used as a means of reinforcing weak tissues in women with pelvic organ prolapse and stress urinary incontinence. OBJECTIVE: We sought to investigate a potential link between the development of systemic/autoimmune disorders and synthetic polypropylene mesh repairs. STUDY DESIGN: New York State Department of Health Statewide Planning and Research Cooperative System data were utilized to conduct this retrospective cohort study. Adult women undergoing surgery for pelvic organ prolapse with vaginally implanted mesh from January 2008 through December 2009 in inpatient and ambulatory surgery settings in New York State were identified. Two separate control cohorts were created to compare outcomes, including a screening colonoscopy cohort and a vaginal hysterectomy cohort for benign gynecologic conditions (without pelvic organ prolapse repair or sling). Patients in the mesh cohort were individually matched to the control cohorts based on demographics, comorbidities, and procedure date. The development of systemic/autoimmune disease was determined before and after matching for 1-year, 2-year, 3-year, and entire follow-up (up to 6 years until December 2014) and differences between groups were evaluated. RESULTS: A total of 2102 patients underwent mesh-based pelvic organ prolapse surgery from January 2008 through December 2009. In the control cohorts, 37,298 patients underwent colonoscopy and 7338 underwent vaginal hysterectomy. When patients were matched based on demographics, comorbidities, and procedure time, mesh-based surgery was not associated with an increased risk of developing autoimmune disease at any of the evaluated time periods. CONCLUSION: Mesh-based vaginal surgery was not associated with the development of systemic/autoimmune diseases. These data refute claims against mesh as a cause of systemic disease.

Teaching mid-urethral sling surgery to residents: Impact on operative time and postoperative outcomes.

AIMS: The purpose of this study was to determine the impact of resident teaching on outcomes of mid-urethral sling surgery. METHODS: A retrospective review of female patients who underwent an outpatient transobturator (TOT) synthetic mid-urethral sling procedure with and without concomitant prolapse repair by two surgeons (JA, KE) in a tertiary female pelvic medicine practice was performed. Total procedure time (TPT = time from incision to closure including sling placement and any prolapse procedure), estimated blood loss (EBL), and postoperative complications including urinary retention, mesh exposure, reoperation, vaginal bleeding, and leg pain were compared between cases with and without the presence of a resident. RESULTS: One hundred thirty-four women underwent an outpatient transobturator sling procedure. Fifty-seven patients (43%) had a concomitant prolapse procedure. A resident was present at 57% (76/134) of cases. The average observed TPT (±SEM) was 60.6 ± 3.1 min when a resident was present and 46.6 ± 2.5 min when a resident was not present (P = 0.001). However, residents were more likely to be present when concomitant procedures were performed (P = 0.003). After adjusting for this, the presence of a resident increased TPT by an estimated 7.9 ± 2.5 min (P = 0.002). There was no statistical difference in EBL or postoperative complications. CONCLUSIONS: Resident participation in transobturator sling procedures resulted in a statistically significant, although clinically small, increase in operative time and had no significant impact on EBL or postoperative complications.

Reducing Operating Room Turnover Time for Robotic Surgery Using a Motor Racing Pit Stop Model.

BACKGROUND: Operating room (OR) turnover time, time taken between one patient leaving the OR and the next entering, is an important determinant of OR utilization, a key value metric for hospital administrators. Surgical robots have increased the complexity and number of tasks required during an OR turnover, resulting in highly variable OR turnover times. We sought to streamline the turnover process and decrease robotic OR turnover times and increase efficiency. METHODS: Direct observation of 45 pre-intervention robotic OR turnovers was performed. Following a previously successful model for handoffs, we employed concepts from motor racing pit stops, including briefings, leadership, role definition, task allocation and task sequencing. Turnover task cards for staff were developed, and card assignments were distributed for each turnover. Forty-one cases were observed post-intervention. RESULTS: Average total OR turnover time was 99.2 min (95% CI 88.0-110.3) pre-intervention and 53.2 min (95% CI 48.0-58.5) at 3 months post-intervention. Average room ready time from when the patient exited the OR until the surgical technician was ready to receive the next patient was 42.2 min (95% CI 36.7-47.7) before the intervention, which reduced to 27.2 min at 3 months (95% CI 24.7-29.7) post-intervention (p < 0.0001). CONCLUSIONS: Role definition, task allocation and sequencing, combined with a visual cue for ease-of-use, create efficient, and sustainable approaches to decreasing robotic OR turnover times. Broader system changes are needed to capitalize on that result. Pit stop and other high-risk industry models may inform approaches to the management of tasks and teams.