Urogynecology (Hagerstown, Md.)最新文献

Importance: Restricting activity after midurethral slings is an unproven practice.

Objective: The objective of this study was to evaluate the effect of postoperative activity restriction on satisfaction and outcomes after slings.

Study design: This was a multicenter, 2-arm, noninferiority randomized controlled trial. Patients aged 18-85 years undergoing treatment with a midurethral sling were randomized 1:1 to postoperative activity restriction or liberal activity. Restrictions included avoidance of strenuous exercise and heavy lifting. The liberal group was allowed to resume activity at their discretion. Our primary outcome was satisfaction with postoperative instruction at 2 weeks. Secondary outcomes included surgical failure, mesh exposure rates, and other adverse events.

Results: In total, 158 patients were randomized with 80 to the liberal group and 78 to the restricted group. At 2 weeks, 54 (80.6%) of patients in the liberal group and 48 (73.9%) of patients in the restricted group were satisfied. We found statistical evidence supporting the hypothesis that postoperative liberal activity instruction is noninferior to activity restriction with regard to patient satisfaction (P = 0.0281). There was no significant difference in strenuous activity at 2 weeks (P = 0.0824). The liberal group reported significantly more moderate activity at 2 weeks (P = 0.0384) and more strenuous activity at 6 weeks and 6 months (P = 0.0171, P = 0.0118, respectively). The rate of recurrent or persistent stress incontinence for liberal versus restricted groups was 18.52% versus 23.53% (P = 0.635). There were no statistically significant differences in complication rates.

Conclusions: Postoperative liberal activity was noninferior to activity restriction with regard to patients' satisfaction. There was no evidence supporting a statistically significant association between postoperative instruction and negative surgical outcomes.

Importance: The importance of this study was to examine treatment patterns and surgical complications for stress urinary incontinence (SUI).

Objectives: The aim of this study was to describe the treatment of SUI and associated complications in a racially and ethnically diverse population.

Study design: This was a retrospective cohort study of patients with a new diagnosis of SUI. We identified patients who received treatment with a pessary, pelvic floor physical therapy, or surgery. Surgical complications were abstracted. Logistic regression was used to examine the association between race/ethnicity and treatment, as well as surgical complications.

Results: A total of 67,187 patients with a new diagnosis of SUI were included. The population was predominately Hispanic (47.5%) followed by White, Asian, Black, Native Hawaiian/Pacific Islander, and American Indian/Alaska Native. Comparing no treatment to any treatment, all racial/ethnic groups, except American Indian/Alaska Native, had decreased odds of receiving treatment compared with White women. Hispanic and Native Hawaiian/Pacific Islander women had increased odds of referral for pelvic floor physical therapy compared with White women. All racial/ethnic groups, except for American Indian/Alaska Native women, had decreased odds of receiving a sling procedure compared with White women. When these racial/ethnic minority groups did receive treatment, it was more likely to be conservative treatment compared with White women. There were no significant differences in individual surgical complications.

Conclusions: Racial minority women were 20-50% less likely to undergo a sling procedure, commonly posited as the gold standard surgical treatment. Racial minority women were 40-100% more likely to receive conservative management and 20-50% less likely to receive any treatment compared with White women.

Importance: Mixed data exist in the literature regarding the impact of obesity on midurethral sling (MUS) failure rates.

Objective: The aim of this study was to evaluate the impact of obesity and Hispanic ethnicity on MUS failure.

Study design: This was a retrospective cohort study of females who underwent MUS surgery, alone or with concomitant prolapse repair, with at least 1 year of follow-up. Body mass index (BMI) classes were categorized as normal (<25 kg/m2), overweight (25-29.9 kg/m2), obese (30-39.9 kg/m2), and severe obesity (≥40 kg/m2). The primary outcome was MUS failure, defined as a composite of subjectively unchanged or worsened symptoms or need for additional procedures. Secondary outcomes included risk factors related to MUS failure and the effect of ethnicity on MUS failure rates.

Results: A total of 322 women were included for analysis. The mean age was 52.3 years. Increasing BMI was associated with higher MUS failure, with multivariate logistic regression showing a 5% increased risk for each 1 kg/m2 BMI increase. Failure rates were significantly different between normal BMI and severe obesity (16.7% vs 36.4%, P = 0.04). After adjusting for other variables, transobturator slings had a higher risk of failure compared with retropubic slings, whereas surgeon training and patient ethnicity did not affect failure rates.

Conclusions: We found that increasing BMI was associated with higher MUS failures, with significantly higher failure rates in the severely obese population. Although MUS remains the standard of care for treatment of SUI, based on our findings, counseling should be individualized to the patient, taking into account each patient's unique characteristics.

Importance: Although behavioral modifications, medications, and other interventions can improve urinary incontinence (UI), many women never receive them.

Objectives: To better characterize UI treatment patterns in primary care, we examined prescriptions and referrals to pelvic floor physical therapy (PFPT) and specialist physicians within a large Midwestern academic health system.

Study design: Electronic health records were queried to identify a cohort of adult female patients receiving a new UI diagnosis during outpatient primary care visits from 2016 to 2020. Urinary incontinence referrals and referral completion were examined for the overall cohort, and medication prescriptions were examined for women with urgency or mixed UI. Logistic regression was used to assess the association of prescriptions and/or referrals with patient demographics, comorbidities, and UI diagnosis dates.

Results: In the year after primary care UI diagnosis, 37.2% of patients in the overall cohort (n = 4,382) received guideline-concordant care. This included 20.6% of women who were referred for further management: 17.7% to urology/urogynecology and 3.2% to PFPT. Most women who were referred attended an initial appointment. Among those with urgency (n = 2,398) or mixed UI (n = 552), 17.1% were prescribed medication. Women with stress (odds ratio [OR], 3.10; 95% CI, 2.53-3.79) and mixed UI (OR, 6.17; 95% CI, 4.03-9.66) were more likely to be referred for further management, and women diagnosed during the COVID-19 pandemic were less likely to be referred for further care (OR, 0.39; 95% CI, 0.29, 0.48).

Conclusion: Only slightly above 1 in 3 women with a new diagnosis of UI in primary care received guideline-based medications or referrals within 1 year, suggesting missed opportunities for timely care.

Importance: A 2018 Executive Order calling for price transparency required hospitals to publicly provide chargemasters, which are detailed lists of standard price listings for billable medical procedures.

Objectives: The objective of this study was to evaluate price listing variations in common urogynecology procedures.

Study design: This was a cross-sectional study of chargemasters obtained between February and April 2020 from hospitals across 5 states chosen to reflect the diversity of health systems in the United States. Hospital characteristic and quality metric data were obtained from the Homeland Infrastructure Foundation, U.S. Department of Agriculture, and U.S. Centers for Medicare & Medicaid Services websites. Current Procedural Terminology codes and procedure names for 9 urogynecologic procedures were used to search each chargemaster and extract price listings. Price listings were compared with data on quality, population demographics, and hospital characteristics to determine if any significant relationships existed.

Results: Eight hundred thirty-four chargemasters were identified. Price listings for most procedures differed significantly across the 5 states, including colpocleisis, cystoscopy with chemodenervation, diagnostic cystoscopy, diverticulectomy, sacral neuromodulation, midurethral sling, and sacrospinous ligament fixation. Price listings were significantly higher in urban hospitals than rural hospitals for 6 procedures. No significant association was seen with price listing and quality measures for most procedures.

Conclusions: Listed prices varied for several urogynecologic procedures. Some of this variation is associated with hospital characteristics such as urban setting. However, notably, price listing was not associated with quality. Further investigation of chargemaster price listings with hospital characteristics and quality metrics and with what is actually paid by patients is imperative for patients to navigate charges.

Importance: Pelvic floor translabial ultrasound (TLUS) can identify levator ani muscle (LAM) avulsion and ballooning, which some studies have shown to be possible risk factors for prolapse recurrence. Our group uses TLUS to counsel patients preoperatively. If any of these risk factors exist, we offer sacrocolpopexy over vaginal repair. However, some patients, even though they have these possible risk factors, prefer to undergo vaginal surgery.

Objective: The objective of this study was to determine if TLUS LAM avulsion and/or ballooning are risk factors for composite outcome recurrence in patients undergoing sacrospinous ligament fixation for pelvic organ prolapse.

Study design: This was a retrospective observational study. All patients with vaginal apical repair with sacrospinous ligament fixation with preoperative TLUS were included. Demographics, clinical characteristics, and follow-up were analyzed. Multivariable logistic regression analysis was performed for composite outcome that included TLUS risk factors, age, Pelvic Organ Prolapse Quantification System measurements and stage, and variables with P < 0.1 in the univariate analysis.

Results: Eighty-two patients were included. All patients had symptomatic vaginal bulge; 65.4% had stage III prolapse. Concomitant hysterectomy was performed in 54.3%. Median follow-up was 20 months (interquartile range, 8-35 months); 19.8% had LAM avulsion, and 43.2% had ballooning. Anatomic recurrence rate was 23.5%, symptomatic was 22.2%, and reoperation was 1.2%. The composite recurrence rate was 29.6%. In the multivariable logistic regression analysis, unilateral/bilateral avulsion in TLUS was found to be a significant risk factor for composite outcome with an odds ratio of 4.33 (confidence interval, 1.219-15.398; P = 0.023).

Conclusions: Composite outcome of recurrence in our study was 29.6%. Avulsion on TLUS increased the risk of recurrence of pelvic organ prolapse by fourfold.

Importance: Mixed urinary incontinence (MUI) is common and can be challenging to manage.

Objectives: We present the protocol design and rationale of a trial comparing the efficacy of 2 procedures for the treatment of women with MUI refractory to oral treatment. The Midurethral sling versus Botulinum toxin A ( MUSA) trial compares the efficacy of intradetrusor injection of 100 U of onabotulinimtoxinA (an office-based procedure directed at the urgency component) versus midurethral sling (MUS) placement (a surgical procedure directed at the stress component).

Study design: The MUSA is a multicenter, randomized trial of women with MUI electing to undergo procedural treatment for MUI at 7 clinical centers in the NICHD Pelvic Floor Disorders Network. Participants are randomized to either onabotulinumtoxinA 100 U or MUS. OnabotulinimtoxinA recipients may receive an additional injection between 3 and 6 months. Participants may receive additional treatment (including crossover to the alternative study intervention) between 6 and 12 months. The primary outcome is change from baseline in Urogenital Distress Inventory (UDI) at 6 months. Secondary outcomes include change in UDI at 3 and 12 months, irritative and stress subscores of the UDI, urinary incontinence episodes, predictors of poor treatment response, quality of life and global impression outcomes, adverse events, use of additional treatments, and cost effectiveness.

Results: Recruitment and randomization of 150 participants is complete and participants are currently in the follow-up phase.

Conclusions: This trial will provide information to guide care for women with MUI refractory to oral treatment who seek surgical treatment with either onabotulinumtoxinA or MUS.

Importance: Office bladder chemodenervation, performed via cystoscopy with intradetrusor onabotulinumtoxinA (BOTOX) injections, is a common treatment for overactive bladder/urge urinary incontinence. Transcutaneous electric nerve stimulation (TENS) has shown to provide analgesia during office hysteroscopy. Adjuvant analgesia using TENS during bladder chemodenervation has not been studied.

Objective: The primary outcome is a clinically significant (10-mm) difference in pain visual analog scale (VAS) measurements during injections for chemodenervation using active TENS compared with placebo TENS. We hypothesize that active TENS use will significantly change pain VAS scores. Secondary outcomes include 5-point pain Likert scale, satisfaction 10-point scale, and adverse events.

Study design: This was a double-blind randomized control trial of men and women with urinary urge incontinence undergoing office chemodenervation performed in an academic and private setting. Participants were randomized into 2 groups: chemodenervation with active TENS or placebo TENS. Power calculation determined 100 patients would be required detect a difference of 10 mm on pain VAS.

Results: One hundred one (85 female and 16 male) participants were recruited. No differences were noted in the demographics. Participants in the active TENS group reported a difference of greater than 10 mm in pain VAS scores (48 ± 23 vs 31 ± 23, P = 0.01). Satisfaction index scores were high but no difference was noted between groups (8.6 vs 8.7, P = 0.68).

Conclusions: Most participants were eligible to use TENS units. Transcutaneous electric nerve stimulation is a safe and noninvasive adjuvant analgesia option for patients undergoing this procedure. Lower pain levels and high satisfaction rates suggest that this is an additional analgesic option during outpatient chemodenervation.

Abstract: Pelvic floor disorders (PFDs) constitute a major public health issue given their negative effect on quality of life for millions of women worldwide and the associated economic burden. As the prevalence of PFDs continues to increase, novel therapeutic approaches for the effective treatment of these disorders are urgently needed. Regenerative medicine techniques, including cellular therapies, extracellular vesicles, secretomes, platelet-rich plasma, laser therapy, and bioinductive acellular biomaterial scaffolds, are emerging as viable clinical options to counteract urinary and fecal incontinence, as well as pelvic organ prolapse. This brief expert review explores the current state-of-science regarding application of these therapies for the treatment of PFDs. Although regenerative approaches have not been widely deployed in clinical care to date, these innovative techniques show a promising safety profile and potential to positively affect the quality of life of patients with PFDs. Furthermore, investigations focused on regeneration of the main constituents of the pelvic floor and lower urinary tract improve our understanding of the underlying pathophysiology of PFDs. Regenerative medicine techniques have a high potential not only to revolutionize treatment of PFDs but also to prevent these complex conditions.

Abstract: The purpose of this document is to update the 2013 AUGS Position Statement based on subsequent decisions made by the U.S. Food and Drug Administration, published clinical data, and relevant society and national guidelines related to the use of surgical mesh. Urogynecologists specialize in treating pelvic floor disorders, such as pelvic organ prolapse (POP) and urinary incontinence, and have been actively involved and engaged in the national and international discussions and research on the use of surgical mesh in the treatment of POP and stress urinary incontinence. In 2019, the U.S. Food and Drug Administration ordered manufacturers of transvaginally placed mesh kits for prolapse to stop selling and distributing their devices, stating that the data submitted did not provide a reasonable assurance of safety and effectiveness. Evidence supports the use of mesh in synthetic midurethral sling and abdominal sacrocolpopexy. The American Urogynecologic Society (AUGS) remains opposed to any restrictions that ban currently available surgical options performed by qualified and credentialed surgeons on appropriately informed patients with pelvic floor disorders. The AUGS supports the U.S. Food and Drug Administration's recommendations that surgeons thoroughly inform patients seeking treatment for POP about the risks and benefits of all potential treatment options, including nonsurgical options, native tissue vaginal repairs, or abdominally placed mesh. There are certain clinical situations where surgeons may assert that the use and potential benefit of transvaginal mesh for prolapse outweighs the risk of other routes/types of surgery or of not using mesh. The AUGS recommends that surgeons utilize a shared decision-making model in the decision-making process regarding surgical options, including use of transvaginally placed mesh.