Association of COMT genetic polymorphism with neuromodulation treatment response in women with fecal or urinary incontinence.

Background: Prior studies have failed to demonstrate clinical or statistical difference in fecal incontinence (FI) symptom improvement with neuromodulation by percutaneous tibial nerve stimulation (PTNS) vs sham. The results of these studies may be indicative of a placebo or sham effect and led us to investigate possible genetic biomarkers of placebo response among women with FI.

Objective: To evaluate the relationship between response to PTNS or sham and genetic polymorphisms associated with placebo response in women with FI.

The Pelvic Floor Disorders Network: Evolution Over Two Decades of Female Pelvic Floor Research.

Importance: This review aimed to describe research initiatives, evolution, and processes of the Eunice Kennedy Shriver National Institute of Child Health and Human Development-supported Pelvic Floor Disorders Network (PFDN). This may be of interest and inform researchers wishing to conduct multisite coordinated research initiatives as well as to provide perspective to all urogynecologists regarding how the PFDN has evolved and functions.

Study Design: Principal investigators of several PFDN clinical sites and Data Coordinating Center describe more than 20 years of development and maturation of the PFDN.

Racial differences in the levator ani muscle and levator hiatus in individuals of reproductive age.

Background: Most studies on pelvic floor muscle morphology (dimensions, shape) and its relationship with patient characteristic risk factors of pelvic floor dysfunction (demographics, medical history) have largely pertained to White individuals with vaginas. There is a need to establish normative data on pelvic floor muscle anatomy and identify morphological differences in racially diverse cohorts that may play a role in racial differences in the prevalence and pathophysiology of pelvic floor dysfunction.

Objective: This study aimed to compare levator ani muscle thickness and levator hiatal morphology and their association with patient characteristics, between asymptomatic Black and White women-identifying individuals with a vagina of reproductive age.

Vaginal Orthosis After Native Tissue Reconstructive Surgery: Design and Phase 0.

Importance: Pelvic organ prolapse recurrence following native tissue repair occurs with composite failure rates of 9-19% within 12 months, predominantly involving apical/anterior compartments. Objective The objective of this study was to develop a novel vaginal orthosis (NVO) device prototype through an iterative design process based on investigator and user feedback.

Study Design: The NVO was designed based on pelvic floor biomechanical principles to mitigate unopposed intra-abdominal pressure of the anterior vagina by absorbing and redirecting intra-abdominal forces to the levator ani and tailored to accommodate postoperative vaginal caliber and axis.

Obstetric Anal Sphincter Injury Care Bundle: A Quality Improvement Initiative.

Introduction And Hypothesis: The objective was to implement an evidence-based peri-partum care bundle for women sustaining obstetric anal sphincter injuries and to evaluate compliance with recommendations for antibiotics use, repair in the operating room, and follow-up before and after implementation.

Methods: This project was reviewed by the Institutional Review Board and determined to be exempt. A clinical care bundle containing education and standardized orders in the electronic medical record was implemented.

Posterior Tibial Nerve Stimulation With versus Without Mirabegron: A Randomized Controlled Trial.

Introduction And Hypothesis: To compare change in urgency urinary incontinence episodes (UUIEs) in women undergoing posterior tibial nerve stimulation (PTNS) plus mirabegron versus PTNS plus placebo for the treatment of refractory urgency urinary incontinence (UUI). The primary hypothesis was that combination therapy is superior to monotherapy.

Methods: A randomized controlled trial was performed in individuals identifying as female aged ≥ 18 years with UUI symptoms refractory to second-line treatment or who could not tolerate antimuscarinic medications.

Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial.

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.

Effectiveness and safety of a novel, collapsible pessary for management of pelvic organ prolapse.

Background: Pessaries are an effective treatment for pelvic organ prolapse, yet currently available pessaries can cause discomfort during removal and insertion. An early feasibility trial of an investigational, collapsible pessary previously demonstrated mechanical feasibility during a brief 15-minute office trial. Longer-term, patient-centered safety and efficacy data are needed.

Three-year outcomes of a randomized clinical trial of perioperative vaginal estrogen as adjunct to native tissue vaginal apical prolapse repair.

Background: As the muscular and connective tissue components of the vagina are estrogen responsive, clinicians may recommend vaginal estrogen to optimize tissues preoperatively and as a possible means to reduce prolapse recurrence, but long-term effects of perioperative intravaginal estrogen on surgical prolapse management are uncertain.

Objective: This study aimed to compare the efficacy of perioperative vaginal estrogen vs placebo cream in reducing composite surgical treatment failure 36 months after native tissue transvaginal prolapse repair.

Study Design: This was an extended follow-up of a randomized superiority trial conducted at 3 tertiary US sites.

Patient perspectives in adverse event reporting after vaginal apical prolapse surgery.

Background: Many clinical trials use systematic methodology to monitor adverse events and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspectives are often not included in this process.

Objective: This study aimed to compare clinician vs patient grading of adverse event severity in a urogynecologic surgical trial.

Dietary Intake and Symptom Severity in Women with Fecal Incontinence.

Introduction And Hypothesis: The goal of this study was to determine whether dietary fat/fiber intake was associated with fecal incontinence (FI) severity.

Methods: Planned supplemental analysis of a randomized clinical trial evaluating the impact of 12-week treatment with percutaneous tibial nerve stimulation versus sham in reducing FI severity in women. All subjects completed a food screener questionnaire at baseline.

Inhibition of NFAT promotes loss of tissue resident uterine natural killer cells and attendant pregnancy complications in humans.

Unlabelled: Uterine natural killer cells (uNKs) are a tissue resident lymphocyte population that are critical for pregnancy success. Although mouse models have demonstrated that NK deficiency results in abnormal placentation and poor pregnancy outcomes, the generalizability of this knowledge to humans remains unclear. Here we identify uterus transplant (UTx) recipients as a human population with reduced uNK cells and altered pregnancy phenotypes.

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

Importance: The associated effect of duration of the second stage of labor (SSL) on pelvic floor symptoms development is not well studied.

Objective: This study aimed to examine the association between duration of SSL and pelvic floor symptoms at 6 months postpartum among primiparous women.

Study Design: A planned secondary analysis of a multicenter randomized trial evaluating the impact of immediate versus delayed pushing on vaginal delivery rates, maternal morbidity, and neonatal outcomes was conducted between 2014 and 2018.

Treatment of Cervical Cancer Complicated by Advanced Pelvic Organ Prolapse: A Case Report.

Concurrent cervical cancer with advanced pelvic organ prolapse is rare: there are no well-established treatment recommendations. It is hypothesized that chronic irritation, as with long-standing pelvic organ prolapse, may lead to dysplasia and human papillomavirus-independent carcinoma, which represents only 5% of cervical cancers. Two patients with complete uterine procidentia were referred to gynecologic oncology with cervical squamous cell carcinoma; both were clinically staged as International Federation of Gynaecology and Obstetrics IB3.

Characteristics Associated With Recurrent Urinary Tract Infections: A Case-Control Study.

Importance: Recurrent urinary tract infections (rUTIs) affect 2-10% of adult women and are associated with a significant effect on quality of life, daily activities, and mental health.

Objective: The aim of this study was to identify clinical characteristics associated with rUTIs among women seeking care for pelvic floor disorders at an academic tertiary urogynecology clinic.

Study Design: A retrospective case-control study of women presenting to an academic tertiary urogynecology clinic was conducted.

First and Second Stage Risk Factors Associated with Perineal Lacerations.

Objective: To determine intrapartum factors associated with perineal laceration at delivery.

Methods: This was a planned secondary analysis of a multicenter randomized clinical trial of delayed versus immediate pushing among term nulliparous women in labor with neuraxial analgesia conducted in the United States. Intrapartum characteristics were extracted from the medical charts.

A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months.

Introduction And Hypothesis: 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.

Methods: 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).

Trial Design for Mixed Urinary Incontinence: Midurethral Sling Versus Botulinum Toxin A.

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

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

Characteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair.

Objective: To identify clinical and demographic characteristics associated with prolapse recurrence by 12 months after native tissue transvaginal repair.

Methods: This was a planned secondary analysis of a randomized trial including postmenopausal participants with stage 2 or greater apical or anterior vaginal prolapse scheduled for surgical repair at three U.S.

Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair: A Randomized Clinical Trial.

Importance: Surgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a hysterectomy. Clinicians may recommend vaginal estrogen in an effort to reduce prolapse recurrence, but the effects of intravaginal estrogen on surgical prolapse management are uncertain.

Objective: To compare the efficacy of perioperative vaginal estrogen vs placebo cream on prolapse recurrence following native tissue surgical prolapse repair.

Effects of preoperative intravaginal estrogen on pelvic floor disorder symptoms in postmenopausal women with pelvic organ prolapse.

Background: Menopause and the decline in systemic estrogen are associated with the development of pelvic floor disorders, such as prolapse, urinary incontinence, overactive bladder, and vulvovaginal atrophy symptoms. Past evidence suggests that postmenopausal women with symptomatic prolapse gain benefit from the preoperative application of intravaginal estrogen, but it is unknown whether they would experience improvement in other pelvic floor symptoms when treated with intravaginal estrogen.

Objective: This study aimed to determine the effects of intravaginal estrogen (compared with placebo) on stress and urgency urinary incontinence, urinary frequency, sexual function and dyspareunia, and vaginal atrophy symptoms and signs in postmenopausal women with symptomatic prolapse.

Pain Catastrophizing and Impact on Pelvic Floor Surgery Experience.

Importance: Understanding patients' perceptions of symptoms and outcomes of urogynecologic surgery is essential for providing high-quality care.

Objective: The aim of the study was to assess association of pain catastrophizing with pelvic floor symptom distress and impact, postoperative pain, and voiding trial in patients undergoing urogynecologic surgery.

Study Design: Individuals whose self-identified gender was female and were undergoing surgery March 2020-December 2021 were included.

Five-year surgical outcomes of transvaginal apical approaches in women with advanced pelvic organ prolapse.

Introduction And Hypothesis: In women with advanced prolapse, differences in vaginal apex anchoring sites may impact surgical outcomes over time. The primary aim was to compare 5-year surgical outcomes of uterosacral ligament suspension (ULS) versus sacrospinous ligament fixation (SSLF) in women with advanced (stage III-IV) prolapse.

Methods: A secondary analysis was conducted in a subset of women with advanced prolapse from a multicenter randomized trial comparing ULS versus SSLF and its extended follow-up, using publicly accessible de-identified datasets.