Urinary microbiome community types associated with urinary incontinence severity in women.

BACKGROUND: Urinary microbiome (urobiome) studies have previously reported on specific taxa and community differences in women with mixed urinary incontinence compared with controls. Therefore, a hypothesis was made that higher urinary and vaginal microbiome diversity would be associated with increased urinary incontinence severity. OBJECTIVE: This study aimed to test whether specific urinary or vaginal microbiome community types are associated with urinary incontinence severity in a population of women with mixed urinary incontinence. STUDY DESIGN: This planned secondary, cross-sectional analysis evaluated associations between the urinary and vaginal microbiomes and urinary incontinence severity in a subset of Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence trial participants with urinary incontinence. Incontinence severity was measured using bladder diaries and Urinary Distress Inventory questionnaires collected at baseline. Catheterized urine samples and vaginal swabs were concurrently collected before treatment at baseline to assess the urinary and vaginal microbiomes. Of note, 16S rRNA V4 to V6 variable regions were sequenced, characterizing bacterial taxa to the genus level using the DADA2 pipeline and SILVA database. Using Dirichlet multinomial mixtures methods, samples were clustered into community types based on core taxa. Associations between community types and severity measures (Urinary Distress Inventory total scores, Urinary Distress Inventory subscale scores, and the number of urinary incontinence episodes [total, urgency, and stress] from the bladder diary) were evaluated using linear regression models adjusted for age and body mass index. In addition, alpha diversity measures for richness (total taxa numbers) and evenness (proportional distribution of taxa abundance) were analyzed for associations with urinary incontinence episodes and community type. RESULTS: Overall, 6 urinary microbiome community types were identified, characterized by varying levels of common genera (Lactobacillus, Gardnerella, Prevotella, Tepidimonas, Acidovorax, Escherichia, and others). The analysis of urinary incontinence severity in 126 participants with mixed urinary incontinence identified a Lactobacillus-dominated reference group with the highest abundance of Lactobacillus (mean relative abundance of 76%). A community characterized by fewer Lactobacilli (mean relative abundance of 19%) and greater alpha diversity was associated with higher total urinary incontinence episodes (2.67 daily leaks; 95% confidence interval, 0.76-4.59; P=.007) and urgency urinary incontinence episodes (1.75 daily leaks; 95% confidence interval, 0.24-3.27; P=.02) than the reference group. No significant association was observed between community type and stress urinary incontinence episodes or Urogenital Distress Inventory total or subscores. The composition of vaginal community types and urinary community types were similar but composed of slightly different bacterial taxa. Vaginal community types were not associated with urinary incontinence severity, as measured by bladder diary or Urogenital Distress Inventory total and subscale scores. Alpha diversity indicated that greater sample richness was associated with more incontinence episodes (observed genera P=.01) in urine. Measures of evenness (Shannon and Pielou) were not associated with incontinence severity in the urinary or vaginal microbiomes. CONCLUSION: In the urobiome of women with mixed urinary incontinence, a community type with fewer Lactobacilli and more diverse bacteria was associated with more severe urinary incontinence episodes (total and urgency) compared with a community type with high predominance of a single genus, Lactobacillus. Whether mixed urinary incontinence severity is due to lesser predominance of Lactobacillus, greater presence of other non-Lactobacillus genera, or the complement of bacteria consisting of urobiome community types remains to be determined.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Inadequacy and underreporting of study subjects' race and ethnicity in federally funded pelvic floor research.

BACKGROUND: The inclusion of participants who are Black, Indigenous people of color, and participants of various ethnicities is a priority of federally sponsored research. OBJECTIVE: This study aimed to describe the reporting of race and ethnicity in federally funded research published by the Eunice Kennedy Shriver National Institute of Child Health and Human Development-funded Pelvic Floor Disorders Network. STUDY DESIGN: Pelvic Floor Disorders Network publications were reviewed to determine whether race or ethnicity was reported. The number of participants included in each manuscript who were identified as White, Black, Asian, American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, and "other," and the number of participants who identified as having Hispanic ethnicity were recorded. Data were analyzed by publication and by the pelvic floor disorder investigated, including urinary incontinence, pelvic organ prolapse, fecal incontinence, pregnancy-related pelvic floor disorders, and multiple pelvic floor disorders. Many publications reported on overlapping patient populations, which included primary trials and secondary analyses and studies. Data were analyzed both by counting participants every time they were reported in all papers and by counting the unique number of participants in only the original trials (primary paper published). RESULTS: A total of 132 Pelvic Floor Disorders Network publications were published between 2003 and 2020. Of these, 21 were excluded because they were methods papers or described research without participants. Of the 111 remaining articles, 90 (81%) included descriptions of race and 55 (50%) included descriptions of ethnicity. All 13 primary trials described race and 10 of 13 (76.9%) described ethnicity. Of those publications that described race, 50 of 90 (56%) included only the categories of "White," "Black," and "Other," and 14 of 90 (16%) only described the percentage of White patients. Of the 49,218 subjects, there were 43,058 (87%) with reported race and 27,468 (56%) with reported ethnicity. Among subjects with race and ethnicity reported, 79% were reported as White, 9.9% as Black, 0.4% as Asian, 0.1% as American Indian or Alaska Native, and 4% as "other," whereas 13% were reported to be of Hispanic ethnicity. The racial and ethnic diversity varied based on the pelvic floor disorder studied (P<.01), which was driven by pregnancy-related and fecal incontinence studies because these had lower proportions of White patients than studies of other pelvic floor disorders. CONCLUSION: Federally funded Pelvic Floor Disorders Network research does not consistently report the race and ethnicity of participants. Even in the publications that report these characteristics, Black, Indigenous people of color, and people of Hispanic ethnicity are underrepresented. Consistent reporting and recruitment of a diverse population of women is necessary to address this systemic inequity.

Mind-body (hypnotherapy) treatment of women with urgency urinary incontinence: changes in brain attentional networks.

BACKGROUND: Prior study of patients with urgency urinary incontinence by functional magnetic resonance imaging showed altered function in areas of the brain associated with interoception and salience and with attention. Our randomized controlled trial of hypnotherapy for urgency urinary incontinence demonstrated marked improvement in urgency urinary incontinence symptoms at 2 months. A subsample of these women with urgency urinary incontinence underwent functional magnetic resonance imaging before and after treatment. OBJECTIVE: This study aimed to determine if hypnotherapy treatment of urgency urinary incontinence compared with pharmacotherapy was associated with altered brain activation or resting connectivity on functional magnetic resonance imaging. STUDY DESIGN: A subsample of women participating in a randomized controlled trial comparing hypnotherapy vs pharmacotherapy for treatment of urgency urinary incontinence was evaluated with functional magnetic resonance imaging. Scans were obtained pretreatment and 8 to 12 weeks after treatment initiation. Brain activation during bladder filling and resting functional connectivity with an empty and partially filled bladder were assessed. Brain regions of interest were derived from those previously showing differences between healthy controls and participants with untreated urgency urinary incontinence in our prior work and included regions in the interoceptive and salience, ventral attentional, and dorsal attentional networks. RESULTS: After treatment, participants in both groups demonstrated marked improvement in incontinence episodes (P<.001). Bladder-filling task functional magnetic resonance imaging data from the combined groups (n=64, 30 hypnotherapy, 34 pharmacotherapy) demonstrated decreased activation of the left temporoparietal junction, a component of the ventral attentional network (P<.01) compared with baseline. Resting functional connectivity differed only with the bladder partially filled (n=54). Compared with pharmacotherapy, hypnotherapy participants manifested increased functional connectivity between the anterior cingulate cortex and the left dorsolateral prefrontal cortex, a component of the dorsal attentional network (P<.001). CONCLUSION: Successful treatment of urgency urinary incontinence with both pharmacotherapy and hypnotherapy was associated with decreased activation of the ventral (bottom-up) attentional network during bladder filling. This may be attributable to decreased afferent stimuli arising from the bladder in the pharmacotherapy group. In contrast, decreased ventral attentional network activation associated with hypnotherapy may be mediated by the counterbalancing effects of the dorsal (top-down) attentional network.

Sexual function after pelvic organ prolapse surgery: a systematic review comparing different approaches to pelvic floor repair.

OBJECTIVE: Women consider preservation of sexual activity and improvement of sexual function as important goals after pelvic organ prolapse surgery. This systematic review aimed to compare sexual activity and function before and after prolapse surgery among specific approaches to pelvic organ prolapse surgery including native tissue repairs, transvaginal synthetic mesh, biologic grafts, and sacrocolpopexy. DATA SOURCES: MEDLINE, Embase, and ClinicalTrials.gov databases were searched from inception to March 2021. STUDY ELIGIBILITY CRITERIA: Prospective comparative cohort and randomized studies of pelvic organ prolapse surgeries were included that reported the following specific sexual function outcomes: baseline and postoperative sexual activity, dyspareunia, and validated sexual function questionnaire scores. Notably, the following 4 comparisons were made: transvaginal synthetic mesh vs native tissue repairs, sacrocolpopexy vs native tissue repairs, transvaginal synthetic mesh vs sacrocolpopexy, and biologic graft vs native tissue repairs. METHODS: Studies were double screened for inclusion and extracted for population characteristics, sexual function outcomes, and methodological quality. Evidence profiles were generated for each surgery comparison by grading quality of evidence for each outcome across studies using a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS: Screening of 3651 abstracts was performed and identified 77 original studies. The overall quality of evidence was moderate to high. There were 26 studies comparing transvaginal synthetic mesh with native tissue repairs, 5 comparing sacrocolpopexy with native tissue repairs, 5 comparing transvaginal synthetic mesh with sacrocolpopexy, and 7 comparing biologic graft with native tissue repairs. For transvaginal synthetic mesh vs native tissue repairs, no statistical differences were found in baseline or postoperative sexual activity, baseline or postoperative total dyspareunia, persistent dyspareunia, and de novo dyspareunia. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form change scores were not different between transvaginal synthetic mesh and native tissue repairs (net difference, -0.3; 95% confidence interval, -1.4 to 0.8). For sacrocolpopexy vs native tissue repairs, baseline or postoperative sexual activity, baseline or postoperative total dyspareunia, de novo dyspareunia, and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form score differences were not different. For biologic graft vs native tissue repairs, baseline or postoperative sexual activity, baseline or postoperative total dyspareunia, and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form changes were also not different. For transvaginal synthetic mesh vs sacrocolpopexy, there was no difference in sexual activity and sexual function score change. Based on 2 studies, postoperative total dyspareunia was more common in transvaginal synthetic mesh than sacrocolpopexy (27.5% vs 12.2%; odds ratio, 2.72; 95% confidence interval, 1.33-5.58). The prevalence of postoperative dyspareunia was lower than preoperative dyspareunia after all surgery types. CONCLUSION: Sexual function comparisons are most robust between transvaginal synthetic mesh and native tissue repairs and show similar prevalence of sexual activity, de novo dyspareunia, and sexual function scores. Total dyspareunia is higher after transvaginal synthetic mesh than sacrocolpopexy. Although sexual function data are sparse in the other comparisons, no other differences in sexual activity, dyspareunia, and sexual function score change were found.

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.

Sacral neuromodulation for symptomatic chronic urinary retention in females: do age and comorbidities make a difference?

OBJECTIVES: To evaluate if age and medical comorbidities are associated with progression to implantation of sacral neuromodulation devices in women with symptomatic chronic urinary retention. METHODS: This multisite retrospective cohort included women with symptomatic chronic urinary retention who had a trial phase of sacral neuromodulation. The primary outcome was progression to implantation. Post-implantation outcomes were assessed as stable response versus decreased efficacy. A sub-analysis of catheter-reliant (intermittent-self catheterization or indwelling) patients was performed. Age was analyzed by 10-year units (decades of age). Multivariate logistic regression determined odds ratios for outcomes of implantation and for post-implantation stable response. RESULTS: Implantation occurred in 86% (243/284) women across six academic institutions. Most patients (160/243, 66%) were catheter reliant at the time of trial phase. Increased decade of age was associated with reduced implantation in all women [OR 0.54 (95% CI 0.42, 0.70)] and in the subgroup of catheter-reliant women [OR 0.52 (95% CI 0.37, 0.73)]. Post-implantation stable response occurred in 68% (193/243) of women at median follow-up of 2 years (range 0.3-15 years). Medical comorbidities present at the time of trials did not impact progression to implantation or post-implantation success. CONCLUSIONS: Increasing decade of age is associated with reduced implantation in women with symptomatic chronic urinary retention. There is no age cutoff at which outcomes change. Post-implantation stable response was not associated with age or medical comorbidities.

Sacral neuromodulation for overactive bladder in women: do age and comorbidities make a difference?

OBJECTIVE: To evaluate if age and comorbidities are associated with progression from trial phase to implantation of an implantable pulse generator in women with overactive bladder. METHODS: This multisite retrospective cohort included women with overactive bladder with or without urinary incontinence who had a trial phase for sacral neuromodulation. The primary outcome was progression to implantation. A sub-analysis of implanted patients was performed for the outcome of additional therapies or "implant only" for the duration of follow-up. Multivariate logistic regression models including potential predictors of implantation and post-implantation addition of therapies were performed. RESULTS: At six academic institutions, 91% (785/864) of patients progressed to implantation. Post-implantation success was achieved by 69% (536/782) of patients at median follow-up of 2 (range 0.3 to 15) years. Odds of implantation [OR 0.73 (CI 0.61, 0.88)] and post-implantation success [OR 0.78 (CI 0.98, 0.97)] were lower with increasing decades of age. Medical comorbidities evaluated did not affect implantation rates or post-implant success. CONCLUSIONS: Most women have successful sacral neuromodulation trials despite older age and comorbidities. Higher decade of age has a negative effect on odds of implantation and is associated with addition of therapies post-implantation. Comorbidities assessed in this study did not affect implantation or addition of therapies post-implantation. Most women add therapies to improve efficacy post-implantation, and explantation rates are low.

Relationship of postoperative vaginal anatomy and sexual function: a systematic review with meta-analysis.

INTRODUCTION AND HYPOTHESIS: This was a planned secondary analysis of a systematic review that described sexual function outcomes following pelvic organ prolapse (POP) surgery. We aimed to describe the relationship of pre- and postoperative vaginal anatomic measures with sexual function outcomes. Data Sources included the Medline, Embase, and clinicaltrials.gov databases from inception to April 2018. METHODS: The original systematic review included prospective, comparative studies that reported sexual function outcomes before and following POP surgery. Studies were extracted for population characteristics, sexual function outcomes, and vaginal anatomy, including total vaginal length (TVL) and genital hiatus. By meta-regression, we analyzed associations across studies between vaginal anatomic measurements and sexual function using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 (PISQ-12) and dyspareunia outcomes. RESULTS: We screened 3124 abstracts and identified 74 papers representing 67 original studies. Among these, 14 studies reported TVL and PISQ-12 outcomes. Nine studies reported TVL and dyspareunia outcomes, eight studies reported GH and PISQ-12 outcomes, and seven studies reported GH and dyspareunia outcomes. We found no associations between anatomic measures and PISQ-12 or dyspareunia, although, we found a statistically significant association found between preoperative TVL and change in PISQ-12. CONCLUSION: Across studies, the evidence does not support an association between vaginal anatomy and either validated, condition-specific sexual function questionnaires or dyspareunia. However, no study has directly analyzed these associations in the setting of pelvic floor reconstructive surgery.