Impact of the Duration of the Second Stage of Labor on Postpartum Pelvic Floor Symptoms.

IMPORTANCE: The associated effect of duration of the second stage of labor (SSL) on pelvic floor symptoms development is not well studied. OBJECTIVE: This study aimed to examine the association between duration of SSL and pelvic floor symptoms at 6 months postpartum among primiparous women. STUDY DESIGN: A planned secondary analysis of a multicenter randomized trial evaluating the impact of immediate versus delayed pushing on vaginal delivery rates, maternal morbidity, and neonatal outcomes was conducted between 2014 and 2018. For pelvic floor arm participants, demographic, pelvic examination, and validated questionnaire data were collected postpartum. Primary outcome was change in Pelvic Floor Distress Inventory 20 (PFDI-20) score from immediate to 6 months postpartum. Secondary outcomes included changes in the Pelvic Floor Impact Questionnaire, Fecal Incontinence Severity Index, Modified Manchester Health Questionnaire scores, and Pelvic Organ Prolapse Quantification measurements at 6 months postpartum. Participants were analyzed by SSL duration ≤60 minutes or >60 minutes. RESULTS: Of the 2,414 trial participants, 767 (32%) completed pelvic floor assessments at 6 months. Pelvic Floor Distress Inventory 20 scores significantly improved at 6 months in the ≤60 minutes SSL group compared with >60 minutes SSL (-14.3 ± 48.0 and -3.2 ± 45.3, respectively; P = 0.04). Changes from immediate postpartum in total and subscale scores for other questionnaires at 6 months did not differ between groups. Prolapse stage did not differ between groups. Perineal body was significantly shorter in the >60 minutes SSL group (3.7 ± 0.7, 3.5 ± 0.8; P = 0.03). CONCLUSIONS: Women with SSL >60 minutes experience less improvement in PFDI-20 scores at 6 months. Greater tissue and innervation trauma in those with SSL >60 minutes may explain persistently less improvement in PFDI-20 scores.

Vesicovaginal Fistula Repair Simulation Model and Hierarchical Task Analysis.

IMPORTANCE: There is a need for surgeons skilled in vesicovaginal fistula (VVF) repair, yet training opportunities are limited. OBJECTIVES: This study aimed to create a low-fidelity simulation model for transvaginal VVF repair, identify essential steps of VVF repair, and evaluate the model's ability to replicate essential steps. STUDY DESIGN: First, a low-fidelity VVF repair simulation model was designed and built by the authors. Next, a hierarchical task analysis was performed by urogynecologic surgeons with expertise in VVF repair. Each expert submitted an outline of tasks required to perform VVF repair. To control for bias, an education specialist de-identified, reviewed, and collated the submitted outlines. The education specialist then led a focus group, and through a modified Delphi process, the experts reached consensus on the essential steps. A separate group of urogynecologic surgeons then tested the model and completed an anonymous questionnaire assessing how well the model replicated the essential steps. Descriptive analyses were performed. RESULTS: Five experts submitted an outline of steps for transvaginal VVF repair, and 4 experts participated in a focus group to reach consensus on the essential steps. Nine urogynecologic surgeons, with a median of 10 years in practice (interquartile range, 7-12 years), tested the model and completed the postsimulation questionnaire. Most testers thought that tasks involving identification and closure of the fistula were replicated by the model. Testers thought that tasks involving cystoscopy or bladder filling were not replicated by the model. CONCLUSIONS: We developed a novel, low-fidelity transvaginal VVF repair simulation model that consistently replicated tasks involving identification and closure of the fistula.

Cost Effectiveness of Additional Preoperative Telephone Call to Increase Surgical Preparedness: Analysis of a Randomized Clinical Trial.

INTRODUCTION AND HYPOTHESIS: There is a need for cost effective interventions that increase surgical preparedness in urogynecology. METHODS: We performed an ancillary prospective economic evaluation of the Telehealth Intervention to Increase Patient Preparedness for Surgery (TIPPS) Trial, a randomized multicenter trial that evaluated the impact of a preoperative telehealth call on surgical preparedness in women undergoing urogynecologic surgery. A within-trial analysis from the health care sector and societal perspective was performed. Cost-effectiveness was computed from health care sector and societal perspectives, with an 8-week time horizon. RESULTS: A total of 126 women were included in our analysis. QALYs gained were similar between groups (telehealth 0.1414 + 0.0249; usual care 0.1409 + 0.0179). The cumulative mean per-person costs at 8 weeks from the healthcare sector perspective were telehealth call: $8696 +/- 3341; usual care: $8473 +/- 3118 (p = 0.693) and from the societal perspective were telehealth call: $11,195 + 5191; usual care: $11,213 +/- 4869 (p = 0.944). The preoperative telehealth call intervention was not cost effective from the health care sector perspective with an ICER of $460,091/QALY (95%CI -$7,382,608/QALY, $7,673,961) using the generally accepted maximum willingness to pay threshold of $150,000/QALY (Neumann et al. N Engl J Med. 371(9):796-7, 2014). From the societal perspective, because incremental costs per QALY gained were negative $-35,925/QALY (95%CI, -$382,978/QALY, $317,226), results suggest that preoperative telehealth call dominated usual care. CONCLUSIONS: A preoperative telehealth call is cost effective from the society perspective. CLINICAL TRIAL REGISTRATION: Registered with http://ClinicalTrials.gov . Date of registration: March 26, 2019 Date of initial participant enrollment: June 5, 2019 URL: https://clinicaltrials.gov/ct2/show/record/NCT03890471 Clinical trial identification number: NCT03890471.

Health Care Disparities in Patients Undergoing Hysterectomy for Benign Indications: A Systematic Review.

OBJECTIVE: To explore how markers of health care disparity are associated with access to care and outcomes among patients seeking and undergoing hysterectomy for benign indications. DATA SOURCES: PubMed, EMBASE, and ClinicalTrials.gov were searched through January 23, 2022. METHODS OF STUDY SELECTION: The population of interest included patients in the United States who sought or underwent hysterectomy by any approach for benign indications. Health care disparity markers included race, ethnicity, geographic location, insurance status, and others. Outcomes included access to surgery, patient level outcomes, and surgical outcomes. Eligible studies reported multivariable regression analyses that described the independent association between at least one health care disparity risk marker and an outcome. We evaluated direction and strengths of association within studies and consistency across studies. TABULATION, INTEGRATION, AND RESULTS: Of 6,499 abstracts screened, 39 studies with a total of 46 multivariable analyses were included. Having a Black racial identity was consistently associated with decreased access to minimally invasive, laparoscopic, robotic, and vaginal hysterectomy. Being of Hispanic ethnicity and having Asian or Pacific Islander racial identities were associated with decreased access to laparoscopic and vaginal hysterectomy. Black patients were the only racial or ethnic group with an increased association with hysterectomy complications. Medicare insurance was associated with decreased access to laparoscopic hysterectomy, and both Medicaid and Medicare insurance were associated with increased likelihood of hysterectomy complications. Living in the South or Midwest or having less than a college degree education was associated with likelihood of prior hysterectomy. CONCLUSION: Studies suggest that various health care disparity markers are associated with poorer access to less invasive hysterectomy procedures and with poorer outcomes for patients who are undergoing hysterectomy for benign indications. Further research is needed to understand and identify the causes of these disparities, and immediate changes to our health care system are needed to improve access and opportunities for patients facing health care disparities. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021234511.

Three-year patient-reported outcomes of single-incision versus transobturator slings for female stress urinary incontinence are equivalent.

INTRODUCTION AND HYPOTHESIS: Patient-reported outcome measures (PROMs) are important for understanding the success of surgery for stress urinary incontinence, as patient perception of success does not always correlate with physician perception of success. We report PROMS after single-incision slings (SIS) and transobturator mid-urethral slings (TMUS). METHODS: This was a planned outcome analysis of secondary endpoints in a study in which the primary aim was to compare efficiency and safety using a non-inferiority design (results reported previously). In this analysis of quality of life (QOL), validated PROMs were collected at baseline, 6, 12, 18, 24, and 36 months to quantify incontinence severity (Incontinence Severity Index), symptom bother (Urogenital Distress Inventory), disease-specific QOL impact (Urinary Impact Questionnaire), and generic QOL impact (PGI-I; not applicable at baseline). PROMs were analyzed within treatment groups as well as between groups. Propensity score methods were used to adjust for baseline differences between groups. RESULTS: A total of 281 subjects underwent the study procedure (141 SIS, 140 TMUS). Baseline characteristics were balanced after propensity score stratification. Participants had significant improvement in incontinence severity, disease-specific symptom bother, and QOL impact. Improvements persisted through the study and PROMs were similar between treatment groups in all assessment at 36 months CONCLUSIONS: Following SIS and TMUS, patients with stress urinary incontinence had significant improvement in PROMs including Urogenital Distress Inventory, Incontinence Severity Index, and Urinary Impact Questionnaire at 36 months, indicating disease-specific QOL improvement. Patients have a more positive impression of change in stress urinary incontinence symptoms at each follow-up visit, indicating generic QOL improvement.

Prescription Opioid Use for Acute Pain and Persistent Opioid Use After Gynecologic Surgery: A Systematic Review.

OBJECTIVE: To assess the amount of opioid medication used by patients and the prevalence of persistent opioid use after discharge for gynecologic surgery for benign indications. DATA SOURCES: We systematically searched MEDLINE, EMBASE, and ClinicalTrials.gov from inception to October 2020. METHODS OF STUDY SELECTION: Studies with data on gynecologic surgical procedures for benign indications and the amount of outpatient opioids consumed, or the incidence of either persistent opioid use or opioid-use disorder postsurgery were included. Two reviewers independently screened citations and extracted data from eligible studies. TABULATION, INTEGRATION, AND RESULTS: Thirty-six studies (37 articles) met inclusion criteria. Data were extracted from 35 studies; 23 studies included data on opioids consumed after hospital discharge, and 12 studies included data on persistent opioid use after gynecologic surgery. Average morphine milligram equivalents (MME) used in the 14 days after discharge were 54.0 (95% CI 39.9-68.0, seven tablets of 5-mg oxycodone) across all gynecologic surgery types, 35.0 (95% CI 0-75.12, 4.5 tablets of 5-mg oxycodone) after a vaginal hysterectomy, 59.5 (95% CI 44.4-74.6, eight tablets of 5-mg oxycodone) after laparoscopic hysterectomy, and 108.1 (95% CI 80.5-135.8, 14.5 tablets of 5-mg oxycodone) after abdominal hysterectomy. Patients used 22.4 MME (95% CI 12.4-32.3, three tablets of 5-mg oxycodone) within 24 hours of discharge after laparoscopic procedures without hysterectomy and 79.8 MME (95% CI 37.1-122.6, 10.5 tablets of 5-mg oxycodone) from discharge to 7 or 14 days postdischarge after surgery for prolapse. Persistent opioid use occurred in about 4.4% of patients after gynecologic surgery, but this outcome had high heterogeneity due to variation in populations and definitions of the outcome. CONCLUSION: On average, patients use the equivalent of 15 or fewer 5-mg oxycodone tablets (or equivalent) in the 2 weeks after discharge after major gynecologic surgery for benign indications. Persistent opioid use occurred in 4.4% of patients who underwent gynecologic surgery for benign indications. Our findings could help surgeons minimize overprescribing and reduce medication diversion or misuse. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42020146120.

The Impact of Language Discordance on Patients' Perception of a Clinical Encounter and Trust in Provider.

IMPORTANCE: The impact of language discordance on care for Spanish-speaking patients with pelvic floor disorders is unknown. OBJECTIVE: The aim of this study was to compare the impact of language concordance with the impact of language discordance on the patient experience and trust in their provider. METHODS: This cross-sectional cohort study enrolled English- and Spanish-speaking patients during initial evaluation in a urogynecology clinic. English- and Spanish-speaking patients seen by native English- or Spanish-speaking providers were recruited to the language-concordant group. The language-discordant group included Spanish-speaking patients seen with a translator or by nonnative Spanish-speaking providers. Patients completed the Trust in Physician Scale and the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS). Patients and providers rated the provider's Spanish proficiency on a 10-point scale from 0 (low) to 10 (high). Symptom bother questionnaires were completed 4-6 months after enrollment. RESULTS: Eighty women were recruited, with 40 in each group. Mean age was 55.4 ± 12.9 years. The majority identified as White (75%) and Hispanic (77.5%). Trust in Physician Scale scores were similar between groups (46.2 ± 8.5 vs 44.4 ± 7.5, P > 0.05). The provider communication, provider rating, and recommendation domains of the CG-CAHPS did not differ between groups (all P > 0.05). Provider self-rating of Spanish proficiency was lower than patient ratings (7.5 ± 1.8 vs 9.8 ± 0.5, P < 0.001). There was no difference between groups in symptom bother at 4-6 months (all P > 0.05). CONCLUSIONS: Patient-provider language discordance does not affect patient trust in the provider or perception of the encounter as measured by the Trust in Physician Scale and CG-CAHPS questionnaires.

An evidence-based microscopic hematuria care pathway optimizes decision-making among providers.

INTRODUCTION AND HYPOTHESIS: Microscopic hematuria (MH) has many etiologies in women and requires specific gynecologic evaluation. We created a standardized MH pathway to serve as an evidence-based decision aid for providers in our practice. METHODS: Using a modified Delphi process, a multidisciplinary team reviewed existing guidelines for MH diagnosis and treatment to reach consensus on care pathway components. RESULTS: Entry into the care pathway by an advanced practice provider is determined by the finding of ≥3 red blood cells per high-power field (RBC/HPF) on microscopic urinalysis. Initial evaluation includes history and physical exam. If there are signs of a gynecologic cause of MH, the conditions are treated and repeat urinalysis is performed in 6 months. If repeat urinalysis shows persistent MH or there are no other apparent causes for MH, we proceed with risk stratification. Through shared decision-making, low-risk patients may undergo repeat urinalysis in 6 months or cystoscopy with urinary tract ultrasound. For intermediate-risk patients, cystoscopy and urinary tract ultrasound are recommended. For high-risk patients, cystoscopy and axial upper urinary tract imaging are recommended. If evaluation is positive, urology referral is provided. If evaluation is negative, low-risk patients are released from care, but intermediate-risk or high-risk patients undergo repeat urinalysis in 12 months. If repeat urinalysis is positive, shared decision-making is used to determine a plan. CONCLUSIONS: We developed an MH care pathway to standardize care of women with MH across a multidisciplinary group. This pathway serves as a component of value-based care and supports evidence-based care by providers.

Evidence-based pelvic floor disorder care pathways optimize shared decision making between patients and surgeons.

INTRODUCTION AND HYPOTHESIS: Evidence-based care pathways improve care standardization and patient outcomes. We created pelvic organ prolapse (POP) and stress urinary incontinence (SUI) care pathways as decision aids for our multidisciplinary team to use when counseling patients. METHODS: Using a modified Delphi process, an expert team reviewed existing guidelines and literature to reach consensus on pathway definitions and components. RESULTS: Entry to the care pathways occurs via an advanced practice provider visit. Symptom and quality-of-life questionnaires as well as open-ended patient goals are used to guide patient-provider shared decision making. All treatment choices, including surgical and nonsurgical management, are presented to patients by advanced practice providers. Patients electing nonsurgical management follow-up by telehealth (preferred) or in-person visits as determined by the care pathway. Surgeon consultations are scheduled for patients desiring surgery. Surgical patients undergo urodynamics, simple cystometrics or deferred bladder testing according to the urodynamics clinical pathway. Postoperative follow-up includes telehealth visits and minimizes in-person visits for women with uncomplicated postoperative courses. Patients with resolution of symptoms are graduated from clinic and return to their referring physician. The pathways are revised following publication of new compelling evidence. CONCLUSIONS: We developed POP and SUI care pathways to standardize care across a diverse provider group. Advanced practice providers use care pathways with patients as shared decision-making tools for initial evaluation of patients with prolapse and incontinence. These pathways serve as components of value-based care and encourage team members to function independently while utilizing the full scope of their training.

A telehealth intervention to increase patient preparedness for surgery: a randomized trial.

INTRODUCTION AND HYPOTHESIS: Methods to increase surgical preparedness in urogynecology are lacking. Our objective was to evaluate the impact of a preoperative provider-initiated telehealth call on surgical preparedness. METHODS: This was a multicenter randomized controlled trial. Women undergoing surgery for pelvic organ prolapse and/or stress urinary incontinence were randomized to either a telehealth call 3 (± 2) days before surgery plus usual preoperative counseling versus usual preoperative counseling alone. Our primary outcome was surgical preparedness, as measured by the Preoperative Prepardeness Questionnaire. The Modified Surgical Pain Scale, Pelvic Floor Distress Inventory-20, Patient Global Impressions of Improvement, Patient Global Impressions of Severity, Satisfaction with Decision Scale, Decision Regret Scale, and Clavien-Dindo scores were obtained at 4-8 weeks postoperatively and comparisons were made between groups. RESULTS: Mean telehealth call time was 11.1 ± 4.11 min. Women who received a preoperative telehealth call (n = 63) were significantly more prepared for surgery than those who received usual preoperative counseling alone (n = 69); 82.5 vs 59.4%, p < 0.01). A preoperative telehealth call was associated with greater understanding of surgical alternatives (77.8 vs 59.4%, p = 0.03), complications (69.8 vs 47.8%, p = 0.01), hospital-based catheter care (54 vs 34.8%, p = 0.04) and patient perception that nurses and doctors had spent enough time preparing them for their upcoming surgery (84.1 vs 60.9%, p < 0.01). At 4-8 weeks, no differences in postoperative and patient reported outcomes were observed between groups (all p > 0.05). CONCLUSIONS: A short preoperative telehealth call improves patient preparedness for urogynecological surgery.

Women's Experience of Their First Sexual Encounter After Pelvic Reconstructive Surgery.

OBJECTIVE: To describe the timing, quality and patient concerns regarding the first sexual encounter after surgery for pelvic organ prolapse (POP) or urinary incontinence (UI). METHODS: Women scheduled to undergo POP or UI surgery who self-identified as sexually active were recruited to this qualitative study. Routine counseling regarding the return to sexual activity was provided 4-6 weeks postoperatively. Participants completed interviews 2-4 months after their surgery. Interviews were tape recorded, de-identified, and transcribed. Transcriptions were coded for major themes by two independent researchers; disagreements were arbitrated by the research team. Analysis was performed using Dedoose software. RESULTS: Twenty patients with an average age of 52.4 years participated. Most identified themselves as White (85%), one quarter had a history of hysterectomy, and 15% had previously undergone pelvic reconstructive surgery. Nineteen (95%) patients resumed intercourse 2-4 months after surgery. Thematic saturation was reached with major themes of Outside Influences, Conflicting Emotions, Uncertainty, Sexual Changes and Stability, Normalization, and Self-Image. First sexual encounter timing was strongly influenced by partners' desires and fears and physician counseling. Fear of damage to repairs affected patients' comfort with return to sexual activity. Although uncertain of how anatomical changes or presence of mesh would affect function, women hoped that changes would be positive, regardless of preoperative sexual function. Some women found their experience unchanged, whereas others reported need for change in sexual position, use of lubrication, and sensation of foreign body. Positive changes included increase in desire, pleasure, and improvement in orgasm. Self-image generally improved after surgery, which increased women's sexual confidence. CONCLUSION: The return to sexual activity after surgery for POP or UI represents a great unknown for many women. Reports of initial sexual activity after surgery are often positive, and physicians strongly influence initial postoperative sexual encounter timing. Frank counseling about patient and partners' fears regarding the effect of repair on sexual activity would likely improve patients' outcomes.

Stress Urinary Incontinence: Slings, Single-Incision Slings, and Nonmesh Approaches.

Synthetic midurethral slings offer optimal cure rates for the minimally invasive treatment of stress urinary incontinence in women. Performed via a retropubic or transobturator technique, midurethral sling approaches demonstrate comparable efficacy, with unique adverse event profiles. Single incision slings were introduced to minimize the complication of groin pain with full-length transobturator slings and enhance operative recovery. The earliest therapies for stress urinary incontinence including urethral bulking, retropubic colposuspension, and autologous sling offer alternative methods of surgical management without using synthetic mesh. These methods boast satisfactory efficacy with low rates of complications, and may be ideal for appropriately selected patients.

The Use of Ancillary Services Under a Bundled Care Versus a Fee-For-Service Payment Model.

OBJECTIVES: Colocated services in a team-based integrated practice unit (IPU) optimize care of pelvic floor disorders. Our goal was to compare ancillary service utilization in a multidisciplinary IPU between patients covered by a bundled payment model (BPM) versus a traditional fee-for-service model (FFSM). METHODS: Medical records of women attending an IPU for pelvic floor disorders with colocated services, including nutrition, social work, psychiatry, physical therapy, and subspecialty care between October 2017 and December 2018, were included in this retrospective chart review. All patients were offered treatment with ancillary services according to standardized care pathways. Data extracted included patient demographics, pelvic floor disorder diagnoses, baseline severity measures, payment model, and ancillary services used. Univariate and multivariate logistic regression identified variables predicting higher uptake of ancillary services. RESULTS: A total of 575 women with pelvic floor disorders presented for care during the study period, of which 35.14% attended at least 1 appointment with any ancillary services provider. Ancillary service utilization did not differ between patients in the BPM group and those in the FFSM group (36.22 vs 33.47%; P = 0.489). Social work services were more likely to be used by the BPM compared with the FFSM group (15.95 vs 6.28%; P < 0.001). The diagnosis of fecal incontinence was associated with a higher chance of using any ancillary service (odds ratio, 4.91; 95% confidence interval, 1.81-13.33; P = 0.002). CONCLUSIONS: One third of patients with pelvic floor disorders receiving care in an IPU used colocated ancillary services. Utilization does not differ between payment models.

Female Sexual Function following Sling Surgery: A Prospective Parallel Cohort, Multi-Center Study of the Solyx™ Single Incision Sling System versus the Obtryx™ II Sling System.

PURPOSE: Limited data exist regarding sexual function after single incision sling (SIS) surgery. We compared sexual function 36 months postoperatively between patients undergoing SIS and transobturator sling (TMUS) for treatment of stress urinary incontinence. MATERIALS AND METHODS: Assessment of sexual function was a planned secondary objective of this prospective, multi-center study that enrolled women to Solyx SIS or Obtryx II TMUS. The primary study aim was to compare efficacy and safety using non-inferiority design at 36 months. Patient-reported outcomes of sexual function were assessed at baseline and 6, 12, 18, 24 and 36 months using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Changes in sexual function were analyzed within and between groups. Outcomes for patients requiring surgical retreatment were determined. RESULTS: Baseline characteristics were balanced using propensity score stratification (N=141 SIS, N=140 TMUS). Groups were similar in age, body mass index and concomitant surgery performed. Average length of followup was 30 months. Baseline sexual activity was similar (123/141 SIS, 114/140 TMUS, p=0.18). Severity of urinary incontinence did not correlate with baseline sexual activity. Mean PISQ-12 scores increased significantly from baseline to 36 months for both groups, indicating better sexual function at each visit. There were no significant differences in PISQ-12 scores between groups except at 36 months, where the difference was small (-2.5, 95% CI [-4.7, 0.2]). Among patients undergoing surgical retreatment (9/281, 3%), improvement in sexual function was maintained. De novo dyspareunia was rare following both treatments (SIS 1/141, TMUS 0/140, p=1.00). CONCLUSIONS: Patients have significant improvement in sexual function after SIS and TMUS. De novo sexual pain is low after sling surgery.

Patient-defined goals for the treatment of fecal incontinence: a qualitative analysis among women attending a urogynecology clinic.

INTRODUCTION AND HYPOTHESIS: Fecal incontinence treatment goals are understudied and are not described for women presenting to care. Our objective was to explore patient-reported goals for fecal incontinence management among women presenting for care at a pelvic floor disorders clinic and develop a conceptual framework that captures the range of desired treatment outcomes. METHODS: A qualitative analysis of patient-reported goals for women with fecal incontinence attending a pelvic floor disorders clinic from October 2017-November 2019 was conducted. A team-based approach was used to identify themes and emerging concepts and develop a conceptual framework. RESULTS: One hundred patients met the inclusion criteria. Mean age was 58 ± 14 years; 67% were White and 46% non-Hispanic. Seventy-nine percent of women had diagnosis(es) of prolapse, urinary complaints, or another pelvic floor disorder. From 230 unique goals identified, five thematic categories emerged: Emotional Status, Functional Status, Concurrent Pelvic Floor Disorders, Care Seeking, and Treatment Aspirations. Thematic domains not previously represented in other qualitative work include patients' focus on treatment for global pelvic health rather than solely on fecal incontinence and treatment aspirations ranging from improvement to cure. Our model captures the close relationship between all pelvic floor disorders and emotion, which in return affects all facets of care. CONCLUSIONS: Women with fecal incontinence report a range of treatment goals from improvement to complete resolution of symptoms. Focusing treatment on patient goals by addressing global pelvic health and negotiating realistic treatment outcomes may improve care in this population.

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.

Peer-Centered Versus Standard Physician-Centered Video Counseling for Midurethral Sling Surgery: A Randomized Controlled Trial.

OBJECTIVES: Peer counseling may improve upon provider counseling and enhance patient preparedness for midurethral sling (MUS) surgery. We aimed to compare the impact of peer-centered versus standard preoperative video counseling by assessing patient preparedness for MUS surgery. METHODS: Women undergoing MUS were randomized to view either a peer-centered (PEER) or standard physician preoperative counseling video (PHYS). The PEER video featured a woman who had undergone MUS surgery and included the standard risks and benefits as well as additional information identified in prior work as important to patients. The PHYS video featured a surgeon discussing risks and benefits. Patients viewed either video at their preoperative visit and completed the Patient Preparedness Questionnaire (PPQ), Surgical Decision Satisfaction, Decisional Regret Scale, and the Urogenital Distress Inventory Short Form. Patients then underwent standard in-person surgeon counseling. Sessions were timed and compared with historical timed sessions. Our primary outcome was between-group differences in 6-week postoperative PPQ scores. RESULTS: Patient Preparedness Questionnaire scores did not differ between groups (postoperative PPQ scores: median [interquartile range], 95 [84, 100] vs 92 [80, 100]; P=0.50). The PEER group reported higher decisional regret (15 [0, 28.75] vs 0 [0, 10], P=0.02) and less symptom improvement on Urogenital Distress Inventory Short Form change scores compared with the PHYS group (47.2 [37.2, 62.5] vs 36.1 [16.5, 50], P=0.03); secondary outcomes were not different between groups. In-person counseling times decreased after watching either video compared with the institution's historical standard (8:27 minutes [08:56, 17:14] vs 11:34 minutes [5:22, 13:07]; P < 0.005). CONCLUSION: Patient preparedness did not differ between groups. Decision regret did not differ between groups once adjusted for urinary symptoms.

FACE: Female Pelvic Medicine and Reconstructive Surgery Awareness Campaign: Increasing Exposure.

OBJECTIVE: The aims of this study are to identify screening, treatment, and referral practices of primary care physicians (PCPs) for patients with pelvic floor disorders (PFDs) and evaluate awareness of the Female Pelvic Medicine and Reconstructive Surgery (FPMRS) subspecialty. METHODS: We conducted a cross-sectional survey of PCPs using a random sample of 1005 American College of Physicians members, stratified by demographic region. Electronic survey content included awareness of FPMRS certification, comfort diagnosing and treating PFDs, and PFD referral patterns for PCPs. RESULTS: The 399 survey respondents were predominately male and of diverse ages, geographic distribution, and experience level.Forty-eight percent were aware of the FPMRS subspecialty, 31% of FPMRS board certification, and 25% of American Urogynecologic Society. Less than one third screened for PFDs, only two thirds were comfortable diagnosing urinary complaints, and even fewer felt comfortable diagnosing pelvic organ prolapse and fecal incontinence (FI).Eighty-five percent recommended pelvic floor exercises for stress urinary incontinence and referred to urology (29%) or FPMRS (25%) as second-line therapy, whereas 55% recommended medication/fiber for FI and referred to gastroenterology/colorectal surgery (31%) and FPMRS (2%) as second-line therapy.Primary care physicians referred to colorectal surgery for FI (60%), to Ob/Gyn for obstetric anal sphincter injury (38%) and pelvic organ prolapse (57%), and to urology for microscopic hematuria (80%), overactive bladder (60%), recurrent urinary tract infection (75%), stress urinary incontinence (48%), and voiding dysfunction (84%). CONCLUSIONS: Most PCPs do not routinely screen for PFDs, and fewer feel comfortable treating. The majority is unaware of FPMRS and American Urogynecologic Society and more commonly refers PFD patients to other specialists.

Developing Best Clinical Practices Through Outcomes Improvement: An Ongoing Quality Improvement Curriculum for Faculty and Residents.

Introduction: Practice patterns in clinical learning environments are an important predictor of the patient care quality that residents will deliver after training. The Accreditation Council for Graduate Medical Education (ACGME) Clinical Learning Environment Review Evaluation Committee reported that from 2012-2015, residents and fellows rarely engaged in quality improvement (QI) activities. A QI curriculum was created for OB-GYN faculty and trainees to develop and implement best practices and study the resulting improvement in patient outcomes. Methods: Educational leadership in the Dell Medical School Department of Women's Health designed a five-stage curriculum: (1) learning module describing the curriculum's rationale, (2) clinical practice proposal development, (3) implementation/data analysis for selected proposals, (4) dissemination of proposals and outcomes during a live forum, and (5) evaluation. PGY1 and PGY4 OB-GYN residents collaborated in dyads with selected faculty mentors to draft evidence-based proposals. Dyads identified suggested outcomes measures to be analyzed postimplementation. Remaining faculty analyzed outcomes from the previous year's proposals with PGY2 and PGY3 OB-GYN residents. Results: Forum participants, including faculty, residents, nursing staff, and private obstetrician-gynecologists, evaluated the activity. In 2017, 15 (35%) completed the evaluation. All respondents intended to change their practice based on findings. In addition, the 2016 ACGME survey indicated significant increases in faculty perception of resident QI from 58% in 2014-2015 to 89% in 2015-2016 (p = .01) and in collaboration in scholarly activity from 50% to 85% (p < .01). Discussion: This curriculum was effective in engaging OB-GYN faculty and residents in formalized problem-based learning to address QI.

Updates on the diagnostic tools for evaluation of pelvic floor disorders.

PURPOSE OF REVIEW: Pelvic floor disorders are common and cause significant morbidity for women. Recent advances in the evaluation of women with pelvic floor dysfunction have improved diagnostic accuracy and, with the development and use of validated patient-reported outcomes, has improved measurement of outcomes important to patients. We describe recent advances in the evaluation and measurement of pelvic floor disorders (PFDs). RECENT FINDINGS: We describe recent developments in pelvic floor assessment of women with pelvic floor dysfunction. SUMMARY: Complex integration of multiple anatomic structures and their function are necessary for pelvic floor function. Although the pillars of a complete assessment are a thorough history and physical exam, diagnostic tools can aid in fleshing out the correct and complete analysis of the patient suffering from PFDs.