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.

Is Preoperative Type and Screen High-value Care? A Cost-effectiveness Analysis of Performing Preoperative Type and Screen Prior to Urogynecological Surgery.

INTRODUCTION AND HYPOTHESIS: Routine preoperative type and screen (T&S) is often ordered prior to urogynecological surgery but is rarely used. We aimed to assess the cost effectiveness of routine preoperative T&S and determine transfusion and transfusion reaction rates that make universal preoperative T&S cost effective. METHODS: A decision tree model from the health care sector perspective compared costs (2020 US dollars) and effectiveness (quality-adjusted life-years, QALYs) of universal preoperative T&S (cross-matched blood) vs no T&S (O negative blood). Our primary outcome was the incremental cost-effectiveness ratio (ICER). Input parameters included transfusion rates, transfusion reaction incidence, transfusion reaction severity rates, and costs of management. The base case included a transfusion probability of 1.26%; a transfusion reaction probability of 0.0013% with or 0.4% without T&S; and with a transfusion reaction, a 50% probability of inpatient management and 0.0042 annual disutility. Costs were estimated from Medicare national reimbursement schedules. The time horizon was surgery/admission. We assumed a willingness-to-pay threshold of $150,000/QALY. One- and two-way sensitivity analyses were performed. RESULTS: The base case and one-way sensitivity analyses demonstrated that routine preoperative T&S is not cost effective, with an ICER of $63,721,632/QALY. The optimal strategy did not change when base case cost, transfusion probability, or transfusion reaction disutility were varied. Threshold analysis revealed that if transfusion reaction probability without T&S is >12%, routine T&S becomes cost effective. Scenarios identified as cost effective in the threshold and sensitivity analyses fell outside reported rates for urogynecological surgery. CONCLUSIONS: Within broad ranges, preoperative T&S is not cost effective, which supports re-evaluating routine T&S prior to urogynecological surgery.

International urogynecological consultation chapter 4.1: definition of outcomes for pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: This manuscript of Chapter 4 of the International Urogynecological Consultation (IUC) on Pelvic Organ Prolapse (POP) reviews the literature and makes recommendations on the definition of success in the surgical treatment of pelvic organ prolapse. METHODS: An international group containing seven urogynecologists performed an exhaustive search of the literature using two PubMed searches and using PICO methodology. The first search was from 01/01/2012-06/12/2022. A second search from inception to 7/24/2022 was done to access older references. Publications were eliminated if not relevant to the clinical definition of surgical success for the treatment of POP. All abstracts were reviewed for inclusion and any disagreements were adjudicated by majority consensus of the writing group. The resulting list of articles were used to inform a comprehensive review and creation of the definition of success in the surgical treatment of POP. OUTCOMES: The original search yielded 12,161 references of which 45 were used by the writing group. Ultimately, 68 references are included in the manuscript. For research purposes, surgical success should be primarily defined by the absence of bothersome patient bulge symptoms or retreatment for POP and a time frame of at least 12 months follow-up should be used. Secondary outcomes, including anatomic measures of POP and related pelvic floor symptoms, should not contribute to a definition of success or failure. For clinical practice, surgical success should primarily be defined as the absence of bothersome patient bulge symptoms. Surgeons may consider using PASS (patient acceptable symptom state) or patient goal attainment assessments, and patients should be followed for a minimum of at least one encounter at 6-12 weeks post-operatively. For surgeries involving mesh longer-term follow-up is recommended.

Surgeon Counseling Regarding Return to Sexual Activity After Pelvic Reconstructive Surgery.

IMPORTANCE: Patients highly value surgeon counseling regarding the first sexual encounters after pelvic reconstructive surgery. OBJECTIVES: We performed a qualitative analysis of usual surgeon counseling regarding return to sexual activity after surgery for pelvic organ prolapse and/or urinary incontinence. METHODS: Participating surgeons provided a written description of their usual patient counseling regarding return to sexual activity after pelvic organ prolapse or urinary incontinence surgery. Counseling narratives were coded for major themes by 2 independent reviewers; disagreements were arbitrated by the research team. Analysis was performed utilizing Dedoose software and continued until thematic saturation was reached. RESULTS: Twenty-two surgeons participated, and thematic saturation was reached. Six major themes were identified: "Safety of Intercourse," "Specific Suggestions," "Surgical Sequelae," "Patient Control," "Partner Related," "Changes in Experience," and "No Communication." Nearly all participating surgeons included counseling on the safety of intercourse and reassurance that intercourse would not harm the surgical repair. Specific suggestions included different positions, use of lubrication, vaginal estrogen use, specific products/vendors, alternatives to (vaginal) intercourse, and the importance of foreplay. Surgical sequelae discussion included possible interventions for complications, such as persistent sutures in the vagina, abnormal bleeding, or de novo dyspareunia. Counseling regarding changes to the patient's sexual experience ranged from suggestion of improvement to an anticipated negative experience. Surgeons more commonly advised patients that their sexual experience would be worsened or different from baseline; discussion of improvement was less frequent. CONCLUSIONS: Surgeon counseling regarding the postoperative return to sexual activity varies among pelvic reconstructive surgeons. Most reassure patients that intercourse is safe after surgery.

Patient-Reported Outcome Measures for Use in Women With Pelvic Organ Prolapse: A Systematic Review.

OBJECTIVE: To describe the psychometric properties of existing patient-reported outcome measures for women with prolapse using the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) framework. Additional objectives were to describe the patient-reported outcome scoring method or interpretation, methods of administration, and to compile a list of the non-English languages in which the patient-reported outcomes are reportedly validated. DATA SOURCES: PubMed and EMBASE was searched through September 2021. Study characteristics, patient-reported outcome details, and psychometric testing data were extracted. Methodologic quality was assessed with COSMIN guidelines. METHODS OF STUDY SELECTION: Studies reporting the validation of a patient-reported outcome in women with prolapse (or women with pelvic floor disorders that included a prolapse assessment) and reporting psychometric testing data on English-language patient-reported outcome for at least one measurement property per COSMIN and the U.S. Department of Health and Human Services definitions were included, as well as studies reporting the translation of an existing patient-reported outcome into another language, a new method of patient-reported outcome administration, or a scoring interpretation. Studies reporting only pretreatment and posttreatment scores, only content or face validity, or only findings for nonprolapse domains of the patient-reported outcome were excluded. TABULATION, INTEGRATION, AND RESULTS: Fifty-four studies covering 32 patient-reported outcomes were included; 106 studies assessing translation into a non-English language were excluded from the formal review. The number of validation studies per patient-reported outcome (one version of one questionnaire) ranged from 1 to 11. Reliability was the most reported measurement property, and most measurement properties received an average rating of sufficient. The condition-specific patient-reported outcomes had on average more studies and reported data across more measurement properties compared with adapted and generic patient-reported outcomes. CONCLUSION: Although measurement property data vary on patient-reported outcomes for women with prolapse, most data were of good quality. Overall, condition-specific patient-reported outcomes had more studies and reported data across more measurement properties. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021278796.

Dissociation Among Women with Chronic Pelvic Pain: Relation to Surgical Treatment, Pelvic Pain Severity, and Health-Related Quality of Life.

Chronic pelvic pain (CPP) is associated with a history of trauma and symptoms of somatoform dissociation. We aimed to describe how somatoform dissociation impacts CPP symptoms, surgical treatment, and health-related quality of life (HRQOL). Patients (N = 133) diagnosed with CPP presenting for an appointment at a women's health clinic between November, 2019 - July, 2021 were recruited to participate in a cross-sectional study and complete a survey assessing symptoms of somatoform dissociation, post-traumatic stress disorder (PTSD), pelvic pain severity, history of CPP-related surgeries, and mental and physical HRQOL. We also conducted a post-hoc analysis assessing correlations of individual symptom items on the Somatoform Dissociation Questionnaire (SDQ-20) with HRQOL outcomes. We did not find a relationship between somatoform dissociation and pelvic pain severity or surgical history. Physical HRQOL outcomes were related to somatoform dissociation, PTSD symptoms, and pelvic pain severity, while mental HRQOL outcomes were connected to somatoform dissociation and PTSD symptoms. Our study reveals preliminary evidence suggesting that among CPP patients, HRQOL outcomes are affected by unique profiles of positive and negative symptoms of somatoform dissociation, including sensory disturbances, localized genital pain, and generalized numbness and bodily analgesia. Addressing specific symptoms of somatoform dissociation may enhance HRQOL among trauma-exposed women with CPP. Replication studies are needed to validate our findings. Integrating trauma-informed approaches, including standardized evaluations of trauma exposure and symptoms of somatoform dissociation into routine care for women with CPP is encouraged.

Public Awareness of Obesity and Risk of Pelvic Floor Disorders: A Cohort Study.

IMPORTANCE: Obesity is a risk factor for pelvic floor disorders (PFDs), but limited information exists about the public awareness of this association. OBJECTIVE: Our primary objective was to assess awareness of the association between obesity and PFDs, comparing 2 cohorts of women with body mass index (BMI) <30 versus BMI ≥30. STUDY DESIGN: We conducted a cross-sectional, survey-based cohort study. The survey included questions about demographics, height and weight self-assessment, and the risk of PFDs with obesity. Our primary outcome was the rate of women correctly identifying that obesity increases the risk of PFDs. RESULTS: Of 377 eligible participants 272 (72.1%) completed the survey, with 266 analyzed. Of these, 159 (59.8%) had a BMI <30 and 107 (40.2%) had a BMI ≥30. Comparing the cohorts, the lower BMI cohort was older (mean age of 54.4 ± 18.3 vs 48.4 ± 17.5 years, P = 0.008) and had higher rates of graduate/professional school (35.2% vs 19.6%, P = 0.04). Both groups had similarly high rates of PFDs. There was no difference in identifying obesity as a risk factor for PFDs, although the lower BMI group was less likely to identify the implications of weight loss on urinary incontinence (UI) (27.7% vs 45.8%, P = 0.002). Controlling for potential confounders, obesity remained positively associated with knowledge about the implications of weight loss on UI (odds ratio, 2.5; 95% confidence interval, 1.5-4.4). CONCLUSIONS: Few women identified the increased risk of PFDs with obesity. Obese women may have increased awareness of the implications of weight loss on UI.

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.

Validation of the Surgical Preparedness Assessment in women with pelvic floor disorders.

INTRODUCTION AND HYPOTHESIS: We sought to further develop and validate the Surgical Preparedness Assessment (SPA) scale to evaluate patient preparedness for urogynecological surgery. METHODS: This was a planned ancillary analysis of a randomized controlled trial (RCT) evaluating the impact of a preoperative telehealth call on patient preparedness for urogynecological surgery. Patients completed the Preoperative Preparedness Questionnaire (PPQ), the modified Preparedness for Colorectal Cancer Surgery Questionnaire (PCSQ), the Pelvic Floor Distress Inventory (PFDI-20), the Satisfaction Decision Scale (SDS), and the Decision Regret Scale (DRS). Content validity was established through expert opinion and patient cognitive interviews. Factor analysis identified item grouping into domains. Cronbach's alpha reported internal consistency. Known group validity was assessed by comparing intervention arms. External validity was evaluated by comparing intervention arms and correlations with SDS and DRS. RESULTS: Eleven items and 3 domains met the criteria (information needs, satisfaction and pain, and catheterization). Cronbach's alpha values were acceptable for domains and ranged from 0.74 to 0.93. SPA scores did not correlate with other patient-reported outcomes. Mean SPA scores were lower among women who received a telehealth call vs those who did not (1.30 ± 0.31 vs 1.51 ± 0.44; p = 0.002). CONCLUSIONS: The content-valid SPA demonstrates high internal consistency and known group validity.

International Urogynecology Consultation: Patient Reported Outcome Measures (PROs) use in the evaluation of patients with pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Patient-reported outcome measure instruments include patient-reported outcomes (PROs) and patient-reported goals (PRGs), which allow practitioners to measure symptoms and determine outcomes of treatment that matter to patients. METHODS: This is a structured review completed by the International Urogynecology Consultation (IUC), sponsored by the International Urogynecological Association (IUGA). The aim of this working group was to evaluate and synthesize the existing evidence for PROs and PRGs in the initial clinical work-up/evaluation and research arena for patients with pelvic organ prolapse (POP). RESULTS: The initial search generated 3589 non-duplicated studies. After abstract review by 4 authors, 211 full texts were assessed for eligibility by 2 writing group members, and 199 studies were reviewed in detail. Any disagreements on abstract or full-text articles were resolved by a third reviewer or during video meetings as a group. The list of POP PROs and information on PRGs was developed from these articles. Tables were generated to describe the validation of each PRO and to provide currently available, validated translations. CONCLUSIONS: All patients presenting for POP should be evaluated for vaginal, bladder, bowel and sexual symptoms including their goals for symptom treatment. This screening can be facilitated by a validated PRO; however, most PROs provide more information than needed to provide clinical care and were designed for research purposes.

Childhood betrayal trauma, dissociation, and shame impact health-related quality of life among individuals with chronic pelvic pain.

BACKGROUND: High betrayal trauma (HBT), or interpersonal trauma perpetrated by someone close, is linked to dissociation and shame, while trauma perpetrated by someone less close, low betrayal trauma (LBT) is associated with post-traumatic stress disorder (PTSD). OBJECTIVE: Child interpersonal trauma is common among women with chronic pelvic pain (CPP) and can negatively impact physical and mental health-related quality of life (HRQOL). Our study investigates unexplored connections between these variables. PARTICIPANTS & SETTING: Survey data were analyzed from 96 English-speaking female patients with CPP at a women's health clinic (mean age = 33, 59 % White non-Hispanic, 62 % married or cohabitating, 61.5 % completed post-high school degree); prevalence of HBT and LBT were 65.2 % and 45.6 %, respectively. METHODS: Multiple regression analyzed relationships between mental and physical HRQOL and dissociation, shame, and PTSD. Parallel mediation analyses examined indirect relationships between mental and physical HRQOL and exposure to childhood HBT and LBT. RESULTS: Dissociation was related to worse physical HRQOL, while shame was related to worse physical and mental HRQOL. Dissociation and shame mediated relationships between childhood HBT and current mental (R2 = 0.08, p = .01) and physical (R2 = 0.11, p = .002) HRQOL. Shame, but not PTSD, mediated relationships between childhood LBT and current mental (R2 = 0.14, p < .001) and physical (R2 = 0.16, p < .001) HRQOL. CONCLUSIONS: Our study provides preliminary evidence that dissociation and shame negatively impact HRQOL among individuals with CPP in the context of exposure to different types of childhood betrayal trauma. Replication studies to validate our results with larger samples and longitudinal designs are encouraged.

3D quantitative analysis of normal clitoral anatomy in nulliparous women by MRI.

INTRODUCTION AND HYPOTHESIS: We present a 3D computational approach for automated clitoral measurements. We hypothesized that computationally derived measurements would be comparable and less variable than reported manual measures. METHODS: In this retrospective study, MRIs of 22 nulliparous women age 20-49 years with normal vaginal and clitoral anatomy were collected. Manual segmentations were performed to reconstruct 3D models of the whole clitoris (glans, body, crura, and bulbs) and vagina. The length, width, and volume of the clitoral structures and the distance between the vagina and clitoral structures were calculated. Computed clitoral morphometrics (length, width) were compared to median [range] values from a previously published cadaver study (N = 22) using the median test and Moses extreme reaction test. Calculated distances were compared to mean (± SD) reported by a 2D MRI study (N = 20) using independent t-test and Levene's test. RESULTS: Overall, computed clitoral morphometrics were similar to manual cadaver measurements, where the majority of length and width measures had ~1-2 mm difference and had less variability (smaller range). All calculated distances were significantly smaller and had smaller SDs than manual 2D MRI values, with two-fold differences in the means and SDs. Large variation was observed in clitoral volumetric measures in our cohort. CONCLUSIONS: The proposed 3D computational method improves the standardization and consistency of clitoral measurements compared to traditional manual approaches. The use of this approach in radiographic studies will give better insight into how clitoral anatomy relates to sexual function and how both are impacted by gynecologic surgery, where outcomes can assist treatment planning.

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.

Improved body image after uterovaginal prolapse surgery with or without hysterectomy.

INTRODUCTION AND HYPOTHESIS: The objective was to compare body image and sexual activity and function changes up to 3 years after sacrospinous ligament fixation with graft hysteropexy or vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). METHODS: This was a planned secondary analysis of a multi-center randomized trial of women undergoing prolapse repair with mesh hysteropexy versus hysterectomy. Women were masked to intervention. The modified Body Image Scale (BIS), sexual activity status, and Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) scores were reported at baseline and 1.5, 6, 12, 18, 24, and 36 months after surgery. We compared mean BIS and PISQ-IR scores, the proportion of women whose BIS scores met a distribution-based estimate of the minimally important difference (MID), and sexual activity status. Comparisons were analyzed with linear and logistic repeated measures models adjusted for site, intervention, visit, and intervention by visit interaction. RESULTS: Eighty-eight women underwent mesh hysteropexy; 87 underwent hysterectomy. Women were similar with regard to baseline characteristics, mean age 65.9 ± 7.3 years, and most had stage III or IV prolapse (81%). Baseline mean BIS scores were not significantly different, improved in both groups by 1.5 months, and were sustained through 36 months with no differences between groups (all p > 0.05). The estimated BIS MID was 3; and by 36 months, more women in the mesh hysteropexy group achieved the MID than in the hysterectomy group (62% vs 44%, p = 0.04). The makeup of the sexually active cohort changed throughout the study, making function comparisons difficult. CONCLUSIONS: Body image improves following prolapse surgery whether or not hysterectomy is performed or transvaginal mesh is used at the time of repair; sexual activity status changes over time following prolapse surgery.

Association between the urogenital microbiome and surgical treatment response in women undergoing midurethral sling operation for mixed urinary incontinence.

BACKGROUND: The urogenital microbiome is associated with urgency and mixed urinary incontinence symptoms and differential treatment responses to pharmacotherapy for urgency urinary incontinence. OBJECTIVE: This study aimed to describe whether the preoperative urinary and vaginal microbiomes were associated with surgical treatment responses at 12 months after a midurethral sling operation in women with mixed urinary incontinence. STUDY DESIGN: This cohort study compared the preoperative microbiome compositions of urine and vaginal samples from a subset of women undergoing a midurethral sling operation in the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence trial (NCT01959347) and compared the microbiota in women who were surgical responders vs surgical nonresponders. Twelve-month objective response was defined as a ≥70% reduction from baseline urinary incontinence episodes on a 3-day diary. Subjective response was defined as a change from baseline in the Urogenital Distress Inventory scores. Bacterial abundance and beta diversity were assessed using 16S ribosomal RNA sequencing. The primary differential abundance analysis described predominant bacterial operational taxonomic units associated with responders vs nonresponders using unadjusted and age-adjusted linear models. RESULTS: Objective nonresponders (n=28) compared with responders (n=72) were older (58.5±10.7 vs 51.6±10.2 years) and more likely postmenopausal without hormone use (odds ratio, 6.4; 95% confidence interval, 1.8-22.6). Vaginal and urinary microbiota beta diversities were associated with age (P<.05) for both responders and nonresponders. Overall, predominant operational taxonomic units (genera) were Lactobacillus, Gardnerella, Tepidimonas, Escherichia, Streptococcus, and Prevotella. Operational taxonomic units from baseline urine samples were not significantly associated (P threshold=.05) with surgical treatment responses. A greater abundance of baseline vaginal Lactobacillus was associated with an objective response (P=.04) and Prevotella with an objective nonresponse (P=.01). Adjusting for age, only a greater abundance of baseline vaginal Prevotella was associated with an objective nonresponse (P=.01). Moreover, less abundant vaginal operational taxonomic units were associated with objective and subjective responses and persistent urinary incontinence symptoms (P<.05). CONCLUSION: Women meeting a 70% reduction of urinary incontinence treatment episodes (objective responders) had greater vaginal Lactobacillus at the time of the surgical procedure; however, controlling for age diminished this association. Women not meeting a 70% reduction of urinary incontinence episodes 1 year after a midurethral sling operation had greater vaginal Prevotella at the time of the midurethral sling operation. Further research is needed to determine whether therapy altering the vaginal microbiome may impact surgical treatment responses in women with mixed urinary incontinence.

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.