BACKGROUND:Urogynecologic literature confirms that pelvic floor disorders are detrimental to sexual function in heterosexual women and that sexual function improves following treatment. Few data exist regarding these issues in women who have sex with women, potentially affecting patient-provider interactions, treatment choices and outcomes. OBJECTIVE:To describe sexual function concerns of women with pelvic floor disorders among women who have sex with women. STUDY DESIGN:This was a multicenter qualitative study conducted to explore the sexual function of women who have sex with women and to investigate how pelvic floor dysfunction affected their sexual function. A semistructured interview guide was created to conduct one-on-one interviews via digital conferencing. The audio interviews were transcribed and deidentified. Transcripts were then analyzed with line-by-line coding by at least 2 independent researchers and organized into themes using a team-based approach. Interviews were conducted until thematic saturation was reached. Domains investigated included: knowledge and beliefs regarding pelvic floor disorders, impact of pelvic floor disorders on sexual function, and sexual function in general. RESULTS:Eighteen women who have sex with women participated in cognitive interviews. Thematic saturation was reached. Participants' average age was 49.0 (±16.6) years, the majority self-identified as Non-Hispanic White, were healthy with minimal chronic medical conditions, and were married or living with a partner. Four major concepts emerged from the focus groups: (1) pelvic floor disorders resulted in fear and embarrassment and negatively affected sexual function, (2) women adapted their sexual lives to accommodate pelvic floor disorders, (3) partner choice & communication with that partner could ameliorate pelvic floor disorder effects on sexual function, and (4) women shared impressions potentially affecting future sexual function research and clinical care of women who have sex with women; a need for broader interpretation of sexual activity, the importance of nonjudgment and recognition of potential history of sexual trauma. CONCLUSION:A major theme reported by women with pelvic floor disorders who have sex with women mirrored those of heterosexual women; fear and embarrassment regarding their pelvic floor disorders and their effect on sexual function. These women also voiced novel viewpoints regarding sexual function and amelioration of pelvic floor disorder effects on sexual activity by partner choice and partner communication. Novel issues that could affect future sexual function research and clinical care of women who have sex with women include broadening the definition of sexual activity and emphasizing the importance of nonjudgmental and trauma-informed care.

IMPORTANCE:Women undergoing treatment for urinary incontinence (UI) often have additional pelvic floor disorders (PFDs). It is important to understand the effect of UI-focused pelvic floor muscle training (PFMT) on other PFDs. OBJECTIVE:The objective of this analysis was to evaluate the prevalence of symptoms of pelvic organ prolapse (POP) and fecal incontinence (FI) in women treated for UI, and symptom changes following pelvic floor muscle training (PFMT) with and without a motion-based biofeedback device (MBBD). STUDY DESIGN:This was a post-hoc analysis of a randomized controlled trial comparing PFMT with and without an MBBD in women with UI. Symptomatic PFDs were defined using Pelvic Floor Distress Inventory-20 (PFDI-20) subscales, the Urogenital Distress Inventory Short Form (UDI-6), Colorectal Anal Distress Inventory-8 (CRADI-8), and the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6). Outcomes included the prevalence of multiple PFDs and change in UDI-6, CRADI-8, and POPDI-6 scores among participants with and without concomitant PFDs. RESULTS:A total of 299 women were analyzed. Of 299 women, 161 (57%) reported symptoms of more than 1 PFD. Age and body mass index did not differ. Baseline UDI-6 scores were higher in those with additional PFD symptoms versus UI alone (45.7 ± 15.8 vs 60.7 ± 19.4, P < 0.001). For participants with UI plus at least 1 additional PFD symptom, improvement in UDI-6 scores at 6 and 12 months was significantly greater in the intervention group. For participants with FI, the CRADI-8 was significantly improved from baseline to 8 weeks, 12 months, and 24 months. For participants with POP symptoms, the POPDI score was significantly improved at all time points. CONCLUSIONS:Pelvic floor muscle training is effective in treating UI in the context of additional PFDs, as well as in treating symptoms of FI and POP.

IMPORTANCE Following standardized preoperative education and adoption of shared decision making positively affects postoperative narcotic practices. OBJECTIVES The aim of this study was to assess the impact of patient-centered preoperative education and shared decision making on the quantities of postoperative narcotics prescribed and consumed after urogynecologic surgery. STUDY DESIGN Women undergoing urogynecologic surgery were randomized to "standard" (standard preoperative education, standard narcotic quantities at discharge) or "patient-centered" (patient-informed preoperative education, choice of narcotic quantities at discharge) groups. At discharge, the "standard" group received 30 (major surgery) or 12 (minor surgery) pills of 5-mg oxycodone. The "patient-centered" group chose 0 to 30 (major surgery) or 0 to 12 (minor surgery) pills. Outcomes included postoperative narcotics consumed and unused. Other outcomes included patient satisfaction/preparedness, return to activity, and pain interference. An intention-to-treat analysis was performed. RESULTS The study enrolled 174 women; 154 were randomized and completed the major outcomes of interest (78 in the standard group, 76 in the patient-centered group). Narcotic consumption did not differ between groups (standard group: median of 3.5 pills, interquartile range [IQR] of [0, 8.25]; patient centered: median of 2, IQR of [0, 9.75]; P = 0.627). The patient-centered group had fewer narcotics prescribed (P < 0.001) and unused (P < 0.001), and chose a median of 20 pills (IQR [10, 30]) after a major surgical procedure and 12 pills (IQR [6, 12]) after a minor surgical procedure, with fewer unused narcotics (median difference, 9 pills; 95% confidence interval, 5-13; P < 0.001). There were no differences between groups' return to function, pain interference, and preparedness or satisfaction (P > 0.05). CONCLUSIONS Patient-centered education did not decrease narcotic consumption. Shared decision making did decrease prescribed and unused narcotics. Shared decision making in narcotic prescribing is feasible and may improve postoperative prescribing practices.

Importance The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. Objective To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy. Design, Setting, and Participants This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023. Interventions Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair. Main Outcomes and Measures The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events. Results Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia. Conclusions and Relevance Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach. Trial Registration ClinicalTrials.gov Identifier: NCT02676973

There are sparse data regarding the long-term efficacy of pelvic floor muscle training (PFMT) for the treatment of urinary incontinence (UI). The objective of this study was to evaluate the impact of an 8-week PFMT program guided by a motion-based intravaginal device versus a standard home program over 24 months. Between October 2020 and March 2021, a total of 363 women with stress or stress-predominant mixed UI were randomized and completed an 8-week PFMT program using a motion-based intravaginal device (intervention group) or a home program following written/video instructions (control group). Participants were not asked to continue training after the 8-week program. At 18 and 24 months’ follow-up, the Urogenital Distress Inventory, short-form (UDI-6) and Patient Global Impression of Improvement (PGI-I) were collected. In the original trial, a total of 139 participants in each arm were needed to detect a 0.3 effect size (alpha = 0.05, power 0.8, one-tailed t test) in the difference in UDI-6 scores. A total of 231 participants returned 24-month data. Mean age at 24 months was 51.7 ± 14.5 years, and mean BMI was 31.8 ± 7.4 kg/m2. Mean change in UDI-6 scores from baseline to 24 months was greater in the intervention group than the control group (−21.1 ± 24.5 vs −14.8 ± 19.4, p = 0.04). Reported improvement using PGI-I was greater in the intervention group than in the control group at 24 months (35

Patients with increased surgical preparedness report better outcomes, postoperative satisfaction, and are less likely to report complications. However, minimal data exist on how to increase surgical preparedness.

Pelvic organ prolapse is a common diagnosis especially within the older female population. There are many options for treatment; this article provides a comprehensive review of new and contributory literature on obliterative surgeries as well as a review of their unique advantages and disadvantages compared to non-surgical options and other reconstructive surgeries. Recent literature on obliterative surgeries for pelvic organ prolapse provides further information on body image, post-operative regret, and sexual function after obliterative surgery. In addition, a unique post-operative complication of de novo rectal prolapse is highlighted. Obliterative surgery is a valuable option for an older woman with pelvic organ prolapse who may benefit from a shorter and safer surgery that provides a durable repair. These patients must be appropriately screened and informed of the loss of ability to have penetrative vaginal intercourse, possible intraoperative complications, the impact on body image, as well as the risk de novo rectal prolapse.

Urinary incontinence (UI) is a highly prevalent condition among women worldwide. Although effective nonsurgical treatments exist, including pharmacological, behavioral, and physical therapies, many women with the condition are never diagnosed because of a lack of information, stigma, and the absence of regular screening in primary care, and those who are diagnosed might not receive or adhere to treatment. In this study, the authors present an environmental scan of studies published from 2012 through 2022 that assess the dissemination and implementation of nonsurgical UI treatment-including screening, management, and referral strategies-for women in primary care. The scan was conducted as part of the RAND's support and evaluation contract for the Agency for Healthcare Research and Quality's Managing Urinary Incontinence initiative. The initiative, which builds on the agency's EvidenceNOW model, funds five grant projects to disseminate and implement improved nonsurgical treatment of UI for women within primary care practices in separate regions of the United States.

Women's health research is woefully underfunded. A 2021 study found that in disease states that unequally affect one gender, a disproportionate amount of funding from the National Institutes of Health (NIH) went to male-dominated areas. The authors found that in approximately 75% of cases, the funding was provided to male-dominated diseases.1 In addition to the disproportionately smaller amount of NIH research funding that is allocated to women's health, the majority goes to research involving reproductive-aged women and is often allocated specifically to pregnancy and maternity issues.2 The Office of Research of Women's Health noted that of the proportion of the overall NIH research spending by disease, condition, and special initiative from fiscal year 2017 to 2019, only 10% was allocated to women's health research; however, in that same year, the proportion of that money spent on contraception and pregnancy was 78.6% of the total, despite the fact that women spend the minority of their lives bearing children.2 Women's health care should encompass the full life span of women, including conditions affecting postreproductive and geriatric women, the fastest-growing segment of the U.S. population. Pelvic floor disorders (PFDs) are common conditions that can significantly affect a woman's quality of life. Approximately 25% of women experience at least 1 PFD, and this percentage is likely higher in women older than 65 years, as it is well established that all PFDs increase after menopause.3,4 PURPOSE The American Urogynecologic Society (AUGS) recognizes the importance of evaluating the conditions women face throughout their lives, including conditions that become more prevalent in the postreproductive years. Furthermore, the mission of AUGS is to drive excellence in comprehensive care for women with PFDs. Aligning the mission of AUGS with the need to increase the amount of research funding directed toward women's health beyond maternity and reproductive care identified an opportunity to develop a National Urogynecology Research Agenda focused on research funding for PFDs. At the direction of the AUGS Board of Directors, the AUGS Scientific Committee was charged with the task of creating a Research Agenda that would serve the urogynecology research community by synthesizing and presenting key gaps and research priorities for a variety of PFDs. Six conditions were prioritized for inclusion in the Research Agenda, including pelvic organ prolapse (POP), lower urinary tract symptoms, recurrent urinary tract infections (rUTIs), bladder pain syndrome/interstitial cystitis (BPS/IC) and myofascial pelvic pain (MFPP), female sexual health, and fecal incontinence (FI). Once the working group generated a manuscript and the internal revisions were complete, the Research Agenda was reviewed and edited by 9 external reviewers and then subsequently by the AUGS Publications Committee and the AUGS Board of Directors. Edits were considered, and revisions made accordingly to create the final Research Agenda (https://www.augs.org/research-agenda/). RESULTS The following is a summary of the 6 topics of interest identified for the National Urogynecology Research Agenda. Lower Urinary Tract Symptoms/Urinary Incontinence Stress urinary incontinence (SUI) affects 14%–41% of biologic female patients between the ages of 30 and 60 years.5,6 Overactive bladder in women has been estimated to affect millions with its greatest prevalence (>50%) in adults 60 years or older.7 Numerous studies have demonstrated the negative impact of overactive bladder and SUI on independence, self-esteem, mental health conditions, and interpersonal relationships.8–11 Voiding dysfunction is described using a variety of symptoms that depart from normal voiding sensation and function.7 A large international survey study of a cohort of women older than 40 years reported 5.2% experienced voiding symptoms and 14.9% experienced coexisting voiding and storage symptoms.12,13 The etiologies of voiding dysfunction in women are not well understood. Further, the understanding of the impact of voiding dysfunction on quality of life is limited in part due to the historic lack of validated questionnaires for female voiding dysfunction. The following categories were identified as outstanding knowledge gaps for conditions of lower urinary tract symptoms: clinical phenotyping; combined therapies; voiding dysfunction; health disparities; central nervous system control mechanisms, neuromodulation, and electrostimulation outcomes; biomaterials for SUI treatment; impact of pregnancy/childbirth on lower urinary tract symptoms management; and the impact of anticholinergic medications on cognition. Pelvic Organ Prolapse Pelvic organ prolapse is the descent of 1 or more of the anterior, posterior, or apical pelvic floor compartments, which affects up to 50% of all women.14 This condition can severely affect quality of life, prompting 1 in 7 women in the United States to undergo surgical correction of POP.15,16 Worsening POP has also been associated with deteriorating physical function, anxiety, depression, fatigue, sleep disturbance, and lower satisfaction with participation in social roles.17 Overall, the pathophysiologic mechanisms underlying the development, progression, and severity of POP are inadequately understood. No effective preventive strategies exist against POP, and current treatment modalities are delayed and compensatory. Identified themes within POP that require further exploration in well-designed studies are the following: normal and abnormal functional anatomy and biomechanics; molecular, cellular, genetic, and biomechanical factors; therapies for prevention; treatment, treatment failure and recurrence; health disparities; and societal impact and financial burden of treatment modalities. Fecal Incontinence Fecal incontinence, or accidental bowel leakage, defined as unintentional leakage of mucous, liquid, or solid stool, is a prevalent condition, affecting up to 24% of women.18 Fecal incontinence has a profound negative impact on women's quality of life, as well as a substantial economic burden both at the individual and health care system levels. As a result of the associated stigma, women with FI often suffer in silence. As the prevalence increases with age, paralleling the rapidly growing aging population, the impact of FI on society will continue to expand. Research gaps were identified, and recommendations were provided for the following categories: pathogenesis; classifications of FI types; treatments and prevention; reporting/validated measures; psychosocial consequences and providing support; and research inclusion/diversity. Recurrent UTIs Urinary tract infections are some of the most common bacterial and fungal infections, and they disproportionately affect women. More than one half of women have 1 UTI in their lifetimes, and approximately one third develop rUTI. Women suffering from rUTIs experience burdens related to symptoms and treatment, including adverse effects from antibiotics and risks posed by multidrug- and azole-resistant bacteria. Despite the substantial impact of rUTI, there is a paucity of evidence upon which to base accurate diagnosis, treatment, and prevention. The rUTI working group identified the following research categories: characterization of host-microbial interaction in the female bladder and with neighboring microbial niches, biomarker rapid detection, and patient-centered outcomes and care equity. Recommendations around these categories generally focused on large, multicenter, socioeconomically diverse studies that explore patient-centered outcomes and the impact of rUTI in diverse communities. Sexual Health in Women With PFDs Patients with PFD have a high prevalence of sexual dysfunction, and lack of improvement in sexual function after pelvic reconstructive surgery is viewed by patients as a serious complication. Patients may be embarrassed by urine loss during sexual activity and how their genitalia appear and/or express concerns that their prolapse may prohibit sexual activity.19,20 The societal and economic burden of sexual dysfunction in women with PFDs is high. A more thorough understanding of the prevalence of sexual dysfunction among each of the individual PFDs is essential. There is an urgent need to raise awareness of the importance of sexual function in women with PFDs and to investigate treatments and solutions rather than simply defining the conditions.21,22 Knowledge gaps included the need to improve overall understanding of basic anatomy and physiology and how they relate to sexual function; standardization in terminology, screening, and reporting; patient-centered counseling and changes with PFD surgery on sexual function; and explore sexual health and dysfunction in understudied populations with PFDs. Bladder Pain Syndrome/Interstitial Cystitis and Myofascial Pelvic Pain Bladder pain syndrome/interstitial cystitis and MFPP are 2 chronic pain conditions that are commonly assessed and treated by urogynecologists. Bladder pain syndrome/interstitial cystitis is characterized by bladder pain with associated urinary urgency, frequency, and nocturia lasting greater than 6 weeks in the absence of other identifiable causes.23 Bladder pain syndrome/interstitial cystitis symptoms are common; yet, the condition is often underdiagnosed with a lack of understanding the disease pathogenesis. The etiology of BPS/IC is multifactorial with interactions between autoimmune, neuroendocrine, allergic, and infectious pathways.24,25 Myofascial pelvic pain can be acute; however, the chronic syndrome is characterized by pain originating from the pelvic floor muscles.26 Myofascial pelvic pain is persistent or episodic and occurs in the absence of a local pathological condition with symptoms suggestive of lower urinary tract, sexual, bowel, or gynecological dysfunction.27–31 The etiology of MFPP is also not well understood and is likely multifactorial. Several theories have been suggested, including metabolic imbalance at the motor end plate in peripheral tissue, central sensitization of pain, and neuromuscular microtrauma.32–35 For BPS/IC, 4 categories were identified: diagnosis, disease phenotypes, current treatments, and treatments on the horizon. For MFPP, the following categories were included: prevalence, etiology, diagnosis, and treatment. For each of these categories, knowledge gaps/research priorities were elaborated on with recommendations given for each in the final Research Agenda. CONCLUSION There are extensive areas to be explored in women's health research, especially for conditions women face throughout their lives, including conditions such as PFDs that become more prevalent in the postreproductive years. The main goal of the Research Agenda is to synthesize and present key gaps and research priorities for a variety of PFDs. There is a clear need to increase funding to investigate these crucial topics. The intention is that this agenda will serve as a living document to be updated as knowledge advances and research priorities evolve. This document will also help to guide researchers when putting forth funding applications and should be used by PFD advocates when championing research dollars that can be directed toward women's health care beyond reproduction.

OBJECTIVE: To evaluate the long-term efficacy of an 8-week regimen of pelvic floor muscle training guided by a motion-based digital therapeutic device compared with a standard home program in the treatment of stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI). METHODS: The primary virtual trial was conducted from October 2020 to March 2021; 363 women with SUI or stress-predominant MUI were randomized to complete pelvic floor muscle training using the device (intervention group) or a standard home pelvic floor muscle training program (control group) for 8 weeks. Primary outcomes included change in UDI-6 (Urogenital Distress Inventory, Short Form) score and SUI episodes on a 3-day bladder diary. The PGI-I (Patient Global Impression of Improvement) was also assessed, with "much better " and "very much better " responses considered as improvement. In this planned secondary analysis, symptom and adherence data were collected in follow-up at 6 and 12 months. A modified intention-to-treat analysis was performed using Student's t tests and chi(2) tests as appropriate. RESULTS: Of 299 participants analyzed at 8 weeks, 286 (95.7%) returned 6- and 12-month data (151 in the control group, 135 in the intervention group). Mean age was 51.9 +/- 12.8 years, and mean body mass index (BMI) was 31.8 +/- 7.4; 84.6% of participants were parous, and 54.9% were postmenopausal. Mean change in UDI-6 score from baseline to 6 and 12 months was significantly greater in the intervention group than in the control group (20.2 +/- 20.9 vs 14.8 +/- 19.5, P=.03 and 22.7 +/- 23.3 vs 15.9 +/- 20.3, P=.01, respectively). Participants in the intervention group had more than twice the odds of reporting improvement on the PGI-I compared with participants in the control group (OR 2.45, 95% CI 1.49-4.00). CONCLUSION: Pelvic floor muscle training guided by a motion-based digital therapeutic device yielded significantly greater urinary incontinence symptom improvement compared with a standard home pelvic floor muscle training program at 6 and 12 months, although continued improvement waned over time. This technology may facilitate pelvic floor muscle training access and adherence for women with SUI and stress-predominant MUI and represents an effective modality for scaling first-line care. FUNDING SOURCE: Renovia Inc.

Women over 65 years of age have an increased incidence of low health literacy and represent a cohort with unique surgical preparedness needs. Our objective was to qualitatively describe preoperative counseling experiences in women >65 years of age undergoing urogynecologic surgery. This was an IRB approved qualitative study. Women >65 years of age that spoke English and underwent urogynecologic surgery from January - May 2022 were recruited. Semi-structured, one-to-one interviews were conducted using a standardized interview guide until thematic saturation was reached, with no new information brought forth. We examined topics such as preoperative education, the counseling process, and methods to improve surgical preparedness. Interviews were recorded, de-identified, transcribed, and coded by two independent researchers. Analysis was performed utilizing Dedoose software. A team-based approach was used to identify themes and emerging concepts. Twenty-two participants were interviewed. The mean age was 71 ± 4 years, and most were White, Non-Hispanic (86%) women who underwent varied urogynecologic surgeries (46% apical prolapse repair, 50% anti-incontinence surgery). Four domains were identified: Tailored Counseling, Literacy, Post-Counseling Contact, and Relationship with Healthcare Team. Women expressed varying expectations of their preoperative experience, use of educational material, and age-specific concerns. There was a desire for patient engagement throughout the counseling experience, including teach-back and the use of educational prompts. Women expressed that the patient-provider relationship and transparent communication was key in understanding and preparedness. The patient-provider relationship also stablished a level of trust that influenced several aspects of preparedness. Women expressed struggling with medical jargon. However, they perceived that they comprehended more material during their visit and realized lack of understanding on some topics once revisiting surgical details at home. Post-counseling contact was desired in varied forms including online resources, notes, peer counseling and/or a telephone call. Preoperative counseling experiences in women >65 years of age undergoing urogynecologic surgery were generally positive and influenced by the patient-provider relationship. Several opportunities exist in this group to improve health literacy and increase surgical preparedness.

OBJECTIVE:To compare quality of life (QOL) among patients with endometrial intraepithelial neoplasia or early-stage endometrial cancer and stress urinary incontinence (SUI) who chose to have concomitant surgery with cancer surgery alone.METHODS:A multicenter, prospective cohort study was conducted across eight U.S. sites. Potentially eligible patients were screened for SUI symptoms. Those who screened positive were offered referral to urogynecology and incontinence treatment, including concomitant surgery. Participants were categorized into two groups: 1) concomitant cancer and SUI surgery or 2) cancer surgery alone. The primary outcome was cancer-related QOL as measured by the FACT-En (Functional Assessment of Cancer Therapy-Endometrial) (range 0-100; higher score indicates better QOL). The FACT-En and questionnaires assessing urinary symptom-specific severity and effects were assessed before surgery and 6 weeks, 6 months, and 12 months after surgery. Adjusted median regression accounting for clustering was used to examine the relationship between SUI treatment group and FACT-En scores.RESULTS:Of 1,322 (53.1%) patients, 702 screened positive for SUI with 532 analyzed; 110 (21%) chose concomitant cancer and SUI surgery, and 422 (79%) chose cancer surgery alone. FACT-En scores increased for both the concomitant SUI surgery and cancer surgery-only groups from the preoperative to the postoperative period. After adjustment for timepoint and preoperative covariates, the median change in FACT-En score (postoperative-preoperative) was 1.2 points higher (95% CI -1.3 to 3.6) for the concomitant SUI surgery group compared with the cancer surgery-only group across the postoperative period. Median time until surgery (22 days vs 16 days; P <.001), estimated blood loss (150 mL vs 72.5 mL; P <.001), and operative time (185.5 minutes vs 152 minutes; P <.001) were all greater for the concomitant cancer and SUI surgery group compared with the cancer-only group, respectively.CONCLUSION:Concomitant surgery did not result in improved QOL compared with cancer surgery alone for endometrial intraepithelial neoplasia and patients with early-stage endometrial cancer with SUI. However, FACT-En scores were improved in both groups.

Study ObjectiveFemale patients with chronic pelvic pain (CPP) face complicated healthcare journeys, but narrative perspectives on CPP treatment are lacking.DesignWe collected data in English and Spanish from discussion groups and individual interviews with stakeholders around female CPP.SettingA tertiary care center for gynecologic care.PatientsPatients with CPP who self-identified as women/female, community healthcare workers, and providers who care for women with CPP.InterventionsWe conducted discussion groups with all 3 types of stakeholders and individual interviews with female patients who have CPP.Measurements and Main ResultsPatient participants completed condition specific validated questionnaires. De-identified transcripts were coded with NVivo software. We contrasted patient characteristics and codes between patients with CPP who did and did not report opioid use in the last 90 days. The mean pain score of patient participants was 6/10 ± 2/10, and 14 of 47 (28%) reported recent opioid use, without significant differences between patients with and without recent opioid use. Thematic saturation was achieved. Five main themes emerged: the debilitating nature of CPP, emotional impacts of CPP, challenges in CPP healthcare interactions, treatment for CPP, and the value of not feeling alone. Common threads voiced by stakeholders included difficulty discussing chronic pain with others, a sense of inertia in treatment, interest in alternative and less invasive treatments before more involved treatments, and the need for individualized, stepwise, integrated treatment plans. Participants agreed that opioids should be used when other treatments fail, but women recently using opioids voiced fewer concerns about addiction and positive experiences with opioid efficacy.ConclusionsThese findings among female patients with CPP and also among community healthcare workers and providers advocate for a move toward patient-centered care, particularly the acknowledgment that every woman experiences pain in a singular way. Furthermore, stakeholders voice a deep need for development of individualized treatment plans.

Objectives The objectives of this study are (1) to estimate the incidence of midurethral sling revision/removal in women with preexisting pain diagnoses versus those without these diagnoses and (2) to describe associations between numbers and type of pain diagnoses with revision/removal. Methods Women who underwent midurethral sling surgery between 2009 through 2014 were identified in the MarketScan database and tracked and December 31, 2014. Patients with preoperative chronic pain diagnoses (fibromyalgia, endometriosis, irritable bowel, dyspareunia, low back pain, temporomandibular joint syndrome, interstitial cystitis, pelvic/perineal pain) were compared with controls (those without these diagnoses) regarding mesh sling revision/removal. Logistic regression identified variables associated with mesh revision/removal, and survival analysis compared timing of mesh removal/revision. Results There were 161,459 women who underwent midurethral sling surgery (pain, 83,484; nonpain, 77,975). Pain and nonpain groups differed in age (52.1 vs 53.5 years, P < 0.01) and insurance status (P < 0.01), with the pain group more commonly living in the South or West. Mean follow-up was 42.3 months. Cumulative risk for sling revision/removal was higher in patients with 1 pain diagnosis relative to controls (relative risk, 1.54; 95% confidence interval [CI], 1.41–1.54). Risks increased with increased pain diagnoses (≥4 diagnoses; relative risk, 3.13; 95% CI, 2.81–3.47). Pelvic pain conditions had greatest odds of mesh revision/removal (dyspareunia adjusted odds ratio [aOR], 2.44; 95% CI, 2.23–2.63; interstitial cystitis aOR, 1.46; 95% CI, 1.27–1.66; pelvic/perineal pain aOR, 1.41; 95% CI, 1.33–1.48). Co-occurrence of dyspareunia and interstitial cystitis or pelvic/perineal pain had 12.7% cumulative incidence of sling revision/removal. Cox proportional hazards revealed greatest risk for those with pelvic pain conditions (hazard ratio, 2.40; 95% CI, 2.13–2.70). Conclusions Chronic pain diagnoses increased risk of midurethral sling revision/removal; pelvic pain and numbers of diagnoses increased this risk.

(Abstracted from Obstet Gynecol 2022;139:606–615) As many as 50% of women are affected by urinary incontinence (UI) throughout their lifetimes. Over time, related quality of life and symptom severity tend to worsen and can be improved with therapy.

OBJECTIVE: To evaluate whether pelvic floor muscle training using a motion-based digital intravaginal device is more effective than home pelvic floor muscle training for treatment of stress or stress-predominant mixed urinary incontinence (UI). METHODS: In a remote, virtually executed 8-week prospective randomized controlled superiority trial, women with stress or stress-predominant mixed UI were randomized to pelvic floor muscle training using a motion-based digital therapeutic device or a home training program using written and narrated instructions. Primary outcomes were change in UDI-6 (Urogenital Distress Inventory, Short Form) score and stress urinary incontinence (SUI) episodes on a 3-day bladder diary. A sample size of 139 per group (n=278) was planned to meet the power analysis requirements for the UDI-6 score (n=278) and the bladder diary (n=78). Prespecified secondary outcomes included quality-of-life surveys and adherence reporting. RESULTS: From September 2020 to March 2021, 5,353 participants were screened, and 363 were randomized: 182 in the intervention and 181 in the control group. There were no baseline clinicodemographic differences between groups. The mean change in UDI-6 score was significantly greater for the intervention group compared with the control group (18.8 vs 14.7, P =.01). The median (interquartile range) number of SUI episodes on the 3-day bladder diary was significantly reduced from 5 (3–8) and 5 (3–8) episodes to 1 (0–3) and 2 (1–4) ( P =.005) in the intervention group compared with control group, respectively. A significantly greater number of participants in the intervention group than in the control group reported they were “much improved” or “very much improved” on the PGI-I (Patient Global Impression of Improvement) (63/143 [44.1% vs 45/156 [28.8%], odds ratio 1.94, 95% CI 1.21–3.15). There were no device-related severe adverse events. CONCLUSION: In this all-remote, virtually conducted trial, pelvic floor muscle training guided by a motion-based digital therapeutic device resulted in significantly improved UI symptoms and reduction of UI episodes compared with a home training program. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04508153. FUNDING SOURCE: Renovia Inc.

Pelvic floor muscle training for the treatment of urinary incontinence using a digital therapeutic device shows long-term superior efficacy compared with home pelvic floor muscle training. OBJECTIVE: To evaluate the long-term efficacy of an 8-week regimen of pelvic floor muscle training guided by a motion-based digital therapeutic device compared with a standard home program in the treatment of stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI). METHODS: The primary virtual trial was conducted from October 2020 to March 2021; 363 women with SUI or stress-predominant MUI were randomized to complete pelvic floor muscle training using the device (intervention group) or a standard home pelvic floor muscle training program (control group) for 8 weeks. Primary outcomes included change in UDI-6 (Urogenital Distress Inventory, Short Form) score and SUI episodes on a 3-day bladder diary. The PGI-I (Patient Global Impression of Improvement) was also assessed, with “much better” and “very much better” responses considered as improvement. In this planned secondary analysis, symptom and adherence data were collected in follow-up at 6 and 12 months. A modified intention-to-treat analysis was performed using Student's t tests and χ2 tests as appropriate. RESULTS: Of 299 participants analyzed at 8 weeks, 286 (95.7%) returned 6- and 12-month data (151 in the control group, 135 in the intervention group). Mean age was 51.9±12.8 years, and mean body mass index (BMI) was 31.8±7.4; 84.6% of participants were parous, and 54.9% were postmenopausal. Mean change in UDI-6 score from baseline to 6 and 12 months was significantly greater in the intervention group than in the control group (20.2±20.9 vs 14.8±19.5, P=.03 and 22.7±23.3 vs 15.9±20.3, P=.01, respectively). Participants in the intervention group had more than twice the odds of reporting improvement on the PGI-I compared with participants in the control group (OR 2.45, 95% CI 1.49–4.00). CONCLUSION: Pelvic floor muscle training guided by a motion-based digital therapeutic device yielded significantly greater urinary incontinence symptom improvement compared with a standard home pelvic floor muscle training program at 6 and 12 months, although continued improvement waned over time. This technology may facilitate pelvic floor muscle training access and adherence for women with SUI and stress-predominant MUI and represents an effective modality for scaling first-line care. FUNDING SOURCE: Renovia Inc. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04508153.