Does the setting for intradetrusor onabotulinumtoxinA injection for management of overactive bladder matter?

Introduction: Intradetrusor onabotulinumtoxinA (Botox) injections, to treat idiopathic overactive bladder (OAB), can be performed in the office setting under local analgesia alone or in the operating room (OR) under local and/or sedation. The objective of this study was to compare the symptomatic improvement in patients with OAB who underwent treatment with intradetrusor onabotulinumtoxinA injections in an in-office versus the OR setting. Methods: We performed a multicenter retrospective cohort study of women with the diagnosis of refractory non-neurogenic OAB who elected to undergo treatment with intradetrusor onabotulinumtoxinA injections between January 2015 and December 2020. The electronic medical records were queried for all the demographic and peri-procedural data, including the report of subjective improvement post procedure. Patients were categorized as either "in-office" versus "OR" based on the setting in which they underwent their procedure. Results: Five hundred and thirty-nine patients met the inclusion criteria: 297 (55%) in the in-office group and 242 (45%) in the OR group. A total of 30 (5.6%) patients reported retention after their procedure and it was more common in the in-office group (8.1%) versus the OR group (2.5%), (P = 0.003). The rate of urinary tract infection within 6 months of the procedure was higher in the OR group (26.0% vs. 16.8%, P = 0.009). The overall subjective improvement rate was 77% (95% confidence interval: 73%-80%). Patients in the OR group had a higher reported improvement as compared to the in-office group (81.4% vs. 73.3%, P = 0.03). Conclusions: In this cohort study of patients with OAB undergoing intradetrusor onabotulinumtoxinA injections, post procedural subjective improvement was high regardless of the setting in which the procedure was performed.

Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial.

BACKGROUND: Opioids are routinely prescribed for postoperative pain control after gynecologic surgery with growing evidence showing that most prescribed opioids go unused. Restrictive opioid prescribing has been implemented in other surgical specialties to combat the risk for opioid misuse and diversion. The impact of this practice in the urogynecologic patient population is unknown. OBJECTIVE: This study aimed to determine if a restrictive opioid prescription protocol is noninferior to routine opioid prescribing in terms of patient satisfaction with pain control after minor and major surgeries for prolapse and incontinence. STUDY DESIGN: This was a single-center, randomized, noninferiority trial of opioid-naïve patients who underwent minor (eg, colporrhaphy or mid-urethral sling) or major (eg, vaginal or minimally invasive abdominal prolapse repair) urogynecologic surgery. Patients were excluded if they had contraindications to all multimodal analgesia and if they scored ≥30 on the Pain Catastrophizing Scale. Subjects were randomized on the day of surgery to the standard opioid prescription protocol (wherein patients routinely received an opioid prescription upon discharge [ie, 3-10 tablets of 5 mg oxycodone]) or to the restrictive protocol (no opioid prescription unless the patient requested one). All patients received multimodal pain medications. Participants and caregivers were not blinded. Subjects were asked to record their pain medication use and pain levels for 7 days. The primary outcome was satisfaction with pain control reported at the 6-week postoperative visit. We hypothesized that patient satisfaction with the restrictive protocol would be noninferior to those randomized to the standard protocol. The noninferiority margin was 15 percentage points. Pain level scores, opioid usage, opioid prescription refills, and healthcare use were secondary outcomes assessed for superiority. RESULTS: A total of 133 patients were randomized, and 127 (64 in the standard arm and 63 in the restrictive arm) completed the primary outcome evaluation and were included in the analysis. There were no statistically significant differences between the study groups, and this remained after adjusting for the surgery type. Major urogynecologic surgery was performed in 73.6% of the study population, and minor surgery was performed in 26.4% of the population. Same-day discharge occurred for 87.6% of all subjects. Patient satisfaction was 92.2% in the standard protocol arm and 92.1% in the restrictive protocol arm (difference, -0.1%; P=.004), which met the criterion for noninferiority. No opioid usage in the first 7 days after hospital discharge was reported by 48.4% of the patients in the standard protocol arm and by 70.8% in the restrictive protocol arm (P=.009). Opioid prescription refills occurred in 8.5% of patients with no difference between the study groups (9.4% in the standard arm vs 6.7% in the restrictive arm; P=.661). No difference was seen in the rate of telephone calls and urgent visits for pain control between the study arms. CONCLUSION: Among women who underwent minor and major surgery for prolapse and incontinence, patient satisfaction rates were noninferior after restrictive opioid prescribing when compared with routine opioid prescribing.

Patient Outcomes After Robotic Ventral Rectopexy With Sacrocolpopexy.

IMPORTANCE: As few studies exist examining postoperative functional outcomes in patients undergoing robotic sacrocolpopexy and ventral rectopexy, results from this study can help guide surgeons in counseling patients on their outcomes. OBJECTIVE: The aim of the study was to evaluate functional outcomes and overall postoperative satisfaction as measured by the Pelvic Floor Disability Index 20 (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Patient Global Impression of Improvement Scale (PGI-I) in patients who underwent combined robotic ventral rectopexy and sacrocolpopexy for concomitant pelvic organ prolapse (POP) and rectal prolapse or intussusception (RP/I). METHODS: This was a retrospective cohort and survey study of patients with combined POP and RP/I who underwent the previously mentioned surgical repair between January 2018 and July 2021. Each patient was contacted to participate in a survey evaluating postoperative symptoms related bother, sexual function, and overall satisfaction using the PFDI-20, PISQ-12, and PGI-I. RESULTS: A total of 107 patients met study inclusion criteria with 67 patients completing the surveys. The mean age and body mass index were 63.7 ± 11.5 years and 25.0 ± 5.4, respectively. Of the patients, 19% had a prior RP repair and 23% had a prior POP repair. Rectal prolapse or intussusception recurrence was reported in 10.4% of patients and objective POP recurrence was found in 7.5% of patients. Sixty-seven patients (62%) completed the surveys. The median time to survey follow-up was 18 (8.8-51.8) months. At the time of survey, the mean PFDI-20 score was 95.7 ± 53.7. The mean PISQ-12 score for all patients was 32.8 ± 7.2 and the median PGI-I score was 2.0 (interquartile range, 1.0-3.0). CONCLUSIONS: In this cohort of patients who underwent a combined robotic ventral rectopexy and sacrocolpopexy, patient-reported postoperative symptom bother was low, sexual function was high, and their overall condition was much improved.

Characterization of pentosan polysulfate patients for development of an alert and screening system for ophthalmic monitoring.

OBJECTIVE: Pentosan polysulfate (PPS; ELMIRON, Janssen Pharmaceuticals, Titusville, NJ) is a U.S. Food and Drug Administration-approved oral medication for interstitial cystitis. Numerous reports have been published detailing retinal toxicity with the use of PPS. Studies characterizing this condition are primarily retrospective, and consequently, alert and screening systems need to be developed to actively screen for this disease. The goal of this study was to characterize ophthalmic monitoring trends of a PPS-using patient sample to construct an alert and screening system for monitoring this condition. METHODS: A single-institution retrospective chart review was conducted between January 2005 and November 2020 to characterize PPS use. An electronic medical record (EMR) alert was constructed to trigger based on new PPS prescriptions and renewals offering ophthalmology referral. RESULTS: A total of 1407 PPS users over 15 years was available for characterization, with 1220 (86.7%) being female, the average duration of exposure being 71.2 ± 62.6 months, and the average medication cumulative exposure being 669.7 ± 569.2 g. A total of 151 patients (10.7%) had a recorded visit with an ophthalmologist, with 71 patients (5.0%) having optical coherence tomography imaging. The EMR alert fired for 88 patients over 1 year, with 34 patients (38.6%) either already being screened by an ophthalmologist or having been referred for screening. CONCLUSIONS: An EMR support tool can improve referral rates of PPS maculopathy screening with an ophthalmologist and may serve as an efficient method for longitudinal screening of this condition with the added benefit of informing pentosan polysulfate prescribers about this condition. Effective screening and detection may help determine which patients are at high risk for this condition.

Nonhome Discharge in Patients Undergoing Pelvic Reconstructive Surgery: A National Analysis.

IMPORTANCE: Discharge to home after surgery has been recognized as a determinant of long-term survival and is a common concern in the elderly population. OBJECTIVE: The aim of the study was to determine the incidence and risk factors for nonhome discharge in patients undergoing major surgery for pelvic organ prolapse. STUDY DESIGN: We performed a retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program Database from 2010 to 2018. We included patients who underwent sacrocolpopexy, vaginal colpopexy, and colpocleisis. We compared perioperative characteristics in patients who were discharged home versus those who were discharged to a nonhome location. Stepwise backward multivariate logistic regression was then used to control for confounding variables and identify independent predictors of nonhome discharge. RESULTS: A total of 38,012 patients were included in this study, 209 of whom experienced nonhome discharge (0.5%). Independent predictors of nonhome discharge included preoperative weight loss (adjusted odds ratio [aOR], 5.9; 95% confidence interval [CI], 1.3-27.5), dependent health care status (aOR, 5.0; 95% CI, 2.6-9.5), abdominal hysterectomy (aOR, 2.3; 95% CI, 1.4-3.7), American Society of Anesthesiologists class 3 or greater (aOR, 2.0; 95% CI, 1.5-2.7), age (aOR, 1.1; 95% CI, 1.05-1.09), operative time (aOR, 1.005; 95% CI, 1.003-1.006), laparoscopic hysterectomy (aOR, 0.6; 95% CI, 0.4-1.0), and laparoscopic sacrocolpopexy (aOR, 0.5; 95% CI, 0.3-0.8). CONCLUSIONS: In patients undergoing surgery for pelvic organ prolapse, nonhome discharge is associated with various indicators of frailty, including age, health care dependence, and certain comorbidities. An open surgical approach increases the risk of nonhome discharge, while a laparoscopic approach is associated with lower risk.

Postoperative void trial failure and same-day discharge following apical pelvic organ prolapse surgery: a retrospective matched case-control study.

INTRODUCTION AND HYPOTHESIS: Robust data comparing the timing of voiding trials following prolapse surgery are lacking. Filling in these knowledge gaps would be helpful in counseling patients preoperatively about the concerns regarding same-day discharge. We aimed to compare the rate of a failed void trial after apical pelvic organ prolapse (POP) repair between patients who were discharged on the day of surgery versus those discharged on postoperative day 1. METHODS: This was a retrospective matched case-control study of women who underwent either a laparoscopic/robotic or transvaginal apical POP surgery with or without concurrent hysterectomy. Patients who were discharged on postoperative day 0 (POD0) were identified as cases and matched to control patients discharged on postoperative day 1 (POD1). Patients were matched 1:1 based on age and surgical approach. RESULTS: A total of 59 patients in each group met the inclusion criteria. Of the entire cohort, 34 (28.8%) patients failed their void trial, with no statistically significant difference between those who were discharged on POD0 versus POD1 (33.9% vs 23.7%, p=0.47). Patients who were discharged on POD0 were more likely to be diagnosed with a urinary tract infection (22.0% vs 8.4%, p=0.041) during the postoperative period. CONCLUSIONS: In patients undergoing surgery for apical prolapse, there was no difference in the rate of void trial failure in those who had a catheter removal on the day of surgery compared with those who experienced removal the following day.

Adherence to Pelvic Floor Physical Therapy Referrals in Women With Fecal Incontinence.

OBJECTIVES: This study aimed to determine the incidence of patient adherence with prescribed pelvic floor physical therapy (PFPT) in women presenting with fecal incontinence (FI) and to describe patient characteristics associated with nonadherence. METHODS: This is a retrospective cohort study of women presenting with FI who were prescribed PFPT between January 2010 and December 2019. Adherence with PFPT was defined as either completion of documented recommended physical therapy sessions or discharge from therapy by the therapist before completion of the prescribed sessions. RESULTS: Complete data were available for 248 patients. A total of 159 (64.1%) patients attended at least 1 session of PFPT. Patients who did not attend any sessions were more likely to have a concurrent diagnosis of pelvic organ prolapse (69.7% vs 55.3%, P = 0.03). When controlled for confounding variables, concurrent prolapse remained associated with nonattendance (adjusted odds ratio of 1.9 [95% confidence interval, 1.0-3.3]). Of the patients who attended PFPT, the adherence rate was 32.7% (n = 50), whereas the rate was 20% for the total cohort. Nonadherent patients were more likely to have a higher body mass index (28.9 vs 26.9, P = 0.02), but this was no longer statistically significant once other patient characteristics were controlled for. Of the entire cohort, 136 (54.8%) followed up with their physicians after the initial referral to PFPT. Of the 59 patients, 43.7% were offered second-line therapy. CONCLUSION: Of the women prescribed PFPT for a diagnosis of FI, approximately two thirds attended at least a single session, but only one third of those patients were adherent with the recommended therapy.

Assessing the Performance of the De Novo Postoperative Stress Urinary Incontinence Calculator.

OBJECTIVE: The aim of the study was to determine the performance of a previously published stress urinary incontinence (SUI) risk calculator in women undergoing minimally invasive or transvaginal apical suspensions. METHODS: Using a database of stress-continent women who underwent minimally invasive or transvaginal apical suspensions, we calculated 2 prediction risks for development of SUI within 12 months based on inclusion of a "prophylactic" midurethral sling at the time of prolapse surgery. Observed subjective and objective continence status was abstracted from medical records. Regression models were created for the outcome of de novo SUI to generate receiver operating curves. Concordance (c) indices were estimated for the overall and procedure subgroups to determine the calculator's ability to discriminate between SUI outcomes. RESULTS: Analyses included 502 women. De novo SUI was observed in 23.5% of women. The mean ± SD calculated risk of de novo SUI if a sling was performed was 18.9% ± 13.9 at 12 months compared with 36.4% ± 8.3 without sling. The calculator's discriminative ability for those with a planned sling was moderate (c-index = 0.55, P = 0.037). The calculator failed to discriminate continence outcomes when a sling was not planned in the overall group (c-index = 0.50, P = 0.799) and individual apical procedures. CONCLUSIONS: The SUI risk calculator is significantly limited in its ability to predict de novo SUI in our population of women planning minimally invasive apical suspensions. Refinements to the calculator model are needed to improve its utility in clinical practice.

Prolapse Recurrence After Sacrocolpopexy Mesh Removal: A Retrospective Cohort Study.

OBJECTIVES: There is limited literature regarding outcomes after sacrocolpopexy mesh removal. We sought to compare the proportion of prolapse recurrence in women after sacrocolpopexy mesh removal with women who underwent sacrocolpopexy without subsequent mesh removal. We hypothesize that more women will experience prolapse recurrence after mesh removal. METHODS: This is a retrospective cohort study of women who underwent sacrocolpopexy mesh removal between 2010 and 2019. These patients were time matched with women who had a sacrocolpopexy but did not undergo mesh removal. Prolapse recurrence was defined as the leading edge past the hymen or retreatment. Analysis was done using χ, Wilcoxon rank-sum, or t test with a Cox proportional hazard model to assess the association between mesh removal and time to recurrence. RESULTS: We identified 26 mesh removals, which were matched with 78 patients without mesh removal. The most common indications for mesh removal were exposure (69.2%) and pain (57.7%). Women who underwent mesh removal were more likely to have Mersilene mesh (19.2% vs 1.3%, P = 0.006). Recurrence occurred in 46% of women who had mesh removal compared with 7.7% in those without (P < 0.001). When adjusted for age, parity, menopause, smoking, and diabetes status, those who had mesh removal had a 15 times higher hazard of prolapse recurrence (adjusted hazard ratio = 15.4, 95% confidence interval = 4.3-54.8, P = <.0001). CONCLUSIONS: When compared with time-matched controls, women who underwent sacrocolpopexy mesh removal had a significantly higher proportion of prolapse recurrence. Prospective studies are needed to further explore the utility of concomitant prolapse repair at the time of mesh removal.

Outcomes of a Staged Midurethral Sling Strategy for Stress Incontinence and Pelvic Organ Prolapse.

OBJECTIVE: To evaluate the proportion of women who experienced resolution of stress urinary incontinence (SUI) symptoms after surgery for pelvic organ prolapse (POP) without a concomitant incontinence procedure. METHODS: We conducted a retrospective observational study of women with preoperative subjective and objective SUI who underwent minimally invasive sacrocolpopexy or uterosacral ligament suspension from 2009 to 2015. We excluded cases with incontinence procedures. The primary outcome was the proportion of women with subjective resolution of SUI postoperatively, defined as the absence of patient reported SUI symptoms during follow-up. Secondary outcomes included the proportion of women who underwent a subsequent staged midurethral sling (MUS) procedure and factors associated with resolution of SUI and staged MUS placement. RESULTS: Of 93 women, most were white (n=90, 98%) with stage III POP (n=55, 59%). Mean age was 59.5±8.9 years and body mass index 28.7±4.7. Seventy-three patients (78%) underwent minimally invasive sacrocolpopexy, and 20 (22%) underwent uterosacral ligament suspension. Median follow-up was 8.3 months (interquartile range 3.4-26.7). Postoperatively, 28 (30%) patients reported resolution of SUI, and 65 (70%) reported persistent SUI. Of the 93 patients, 47 (51%) were treated for persistent SUI and 34 (37%) underwent a staged MUS procedure. Among the staged MUS procedures, 27 (79%) were placed within 12 months. Median time to staged MUS procedure was 5.5 months (interquartile range 4.2-9.9). After controlling for degree of preoperative SUI bother, obese women were less likely to experience resolution of SUI after prolapse repair (odds ratio 0.28, 95% CI 0.08-0.95). We did not identify any factors that were significantly associated with undergoing a staged MUS procedure on univariate analyses (P>.05). CONCLUSION: Preoperative SUI resolved in nearly a third of women after prolapse surgery without a concomitant incontinence procedure. In a population typically offered a concomitant MUS procedure at the time of prolapse repair, a staged approach may result in nearly two-thirds fewer patients undergoing MUS procedures. This information may be helpful during preoperative shared decision making.

Contemporary Approaches to Prescribing Exercise in Coronary Artery Disease Patients.

Health care professionals engaged in the management of coronary artery disease (CAD) patients, both in primary and secondary prevention settings, should possess the knowledge to develop and modify both aerobic exercise as well as musculoskeletal resistance exercise training programs. The traditional exercise prescription (ExRx) for aerobic-type exercise describes the intensity, frequency, duration, and mode of exercise, as well as the rate of progression. The more contemporary ExRx focuses on the energy expenditure associated with all physical activity not just structured exercise bouts. The total "volume or dose" of physical activity is associated with important health outcomes, including the potential to prevent and potentially reverse CAD lesions. Also, emerging evidence supporting the use of high-intensity interval training in CAD patients will also be provided. Furthermore, this review will also address the issue of generating an appropriate ExRx in the absence of maximal exercise "stress" test data, a common occurrence in the primary care setting and in this era of health care cost containment. Prescribing resistance exercise for CAD patients requires careful consideration and will be discussed in this review. Finally, this review will conclude with a section that describes the special considerations and/or modifications for some common comorbidities seen in CAD patients.

Exercise prescription using resting heart rate plus 20 or perceived exertion in cardiac rehabilitation.

PURPOSE: For patients starting a cardiac rehabilitation program, exercise intensity often is set 20 beats per minute above the standing resting heart rate (RHR+20) or in a range of 11 to 13 on Borg's Scale for Rating of Perceived Exertion (RPE 11-13). The purpose of this study was to determine the actual exercise intensity, expressed as a percentage of peak oxygen uptake reserve (%VO2R) using these techniques. METHODS: For this study, 11 new referrals to a phase 2 cardiac rehabilitation program voluntarily underwent a symptom-limited exercise test and a field test that consisted of self-paced over-the-ground walking for 10 minutes at levels corresponding to RPE 11-13 and RHR+20. During both tests, gas exchange data were obtained via the Cosmed K4b and heart rate via the Polar monitor. RESULTS: The mean %VO2R at RHR+20 (41.8 +/- 12.3%) and RPE 11-13 (71 +/- 15.3% mL.kg.min) were significantly different. Exercise at RHR+20 resulted in 4 of the 11 patients (36%) exercising at less than 40% VO2R, 6 of the patients (55%) exercising at 40% to 60% VO2R, and 1 of the patients (9%) exercising at more than 60% VO2R. Exercise at RPE 11-13 resulted in 1 of the 11 patients (9%) exercising at less than 40% VO2R, 1 of the patients at exercising at 40% to 60% VO2R (9%), and 9 of the patients (82%) exercising at more than 60% VO2R. CONCLUSIONS: The results of this study indicate that using RHR+20 or RPE 11-13 to prescribe exercise intensity during over-the-ground walking for phase 2 cardiac rehabilitation patients results in substantial intersubject variability and raises questions about the safety and efficacy of these approaches.