Publications by authors named "Charles Rardin"

Importance: Limited evidence exists on the effect of combined native tissue vaginal prolapse repair with midurethral sling on urgency urinary incontinence (UUI) symptoms.

Objectives: This study aimed to evaluate the effect of combined native tissue vaginal prolapse repair with midurethral sling on UUI symptoms at 12 months postoperatively and identify risk factors for persistent UUI.

Study Design: This secondary analysis utilized data from a randomized trial comparing retropubic versus single-incision slings in women undergoing treatment of stress incontinence and vaginal prolapse with native tissue vaginal repair and midurethral sling.

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Importance: There is limited evidence guiding surgeons in how much mesh to resect when treating mesh complications.

Objective: The aim of the study was to compare rates of recurrent prolapse after mesh excisional surgical procedures for prolapse mesh complications.

Study Design: This multicenter, retrospective cohort study included patients, identified by Current Procedural Terminology codes, who were treated surgically for prolapse mesh complications at 8 institutions between 2010 and 2019.

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Importance: Understanding the diagnostic accuracy of postoperative trial of void (TOV) parameters is important for decision making related to postoperative catheterization.

Objective: The aim of the study was to compare the diagnostic accuracies of common postoperative TOV parameters.

Design: The study population comprised a prospective cohort undergoing outpatient urogynecologic procedures at a tertiary referral center from September 2018 to June 2021.

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Introduction And Objectives: Relevant, meaningful, and achievable data points are critical in objectively assessing quality, utility, and outcomes in female stress urinary incontinence (SUI) surgery. A minimum data set female SUI surgery studies was proposed by the first American Urological Association guidelines on the surgical management of female SUI in 1997, but recommendation adherence has been suboptimal. The Female Stress Urinary Incontinence Surgical Publication Working Group (WG) was created from members of several prominent organizations to formulate a recommended standard of study structure, description, and minimum outcome data set to be utilized in designing and publishing future SUI studies.

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Introduction And Objectives: Relevant, meaningful, and achievable data points are critical in objectively assessing quality, utility, and outcomes in female stress urinary incontinence (SUI) surgery. A minimum data set female SUI surgery studies was proposed by the first American Urological Association guidelines on the surgical management of female SUI in 1997, but recommendation adherence has been suboptimal. The Female Stress Urinary Incontinence Surgical Publication Working Group (WG) was created from members of several prominent organizations to formulate a recommended standard of study structure, description, and minimum outcome data set to be utilized in designing and publishing future SUI studies.

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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.

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Background: The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse.

Objective: The primary aim was to determine if the single-incision sling is noninferior to retropubic sling for the management of stress urinary incontinence among patients undergoing reconstructive or obliterative native tissue vaginal repair. The secondary aims were to compare adverse events and surgeon ease of use with sling assignment.

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Objective: To identify vaginal morphology and position factors associated with prolapse recurrence following vaginal surgery.

Design: Secondary analysis of magnetic resonance images (MRI) of the Defining Mechanisms of Anterior Vaginal Wall Descent cross-sectional study.

Setting: Eight clinical sites in the US Pelvic Floor Disorders Network.

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Importance: Indwelling catheters are a known source of dissatisfaction for postoperative patients. There is a paucity of data describing patient-perceived outcomes associated with the alternative of intermittent self-catheterization (ISC).

Objectives: The aim of this study was to describe patient satisfaction and outcomes associated with ISC after outpatient female pelvic reconstructive surgery.

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Objectives: Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs).

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Background: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the Vaginal hysterectomy with Native Tissue Vault Suspension vs Sacrospinous Hysteropexy with Graft Suspension (Study for Uterine Prolapse Procedures Randomized Trial) trial, sacrospinous hysteropexy with graft (hysteropexy) resulted in a lower composite surgical failure rate than vaginal hysterectomy with uterosacral suspension over 5 years.

Objective: This study aimed to identify factors associated with the rate of surgical failure over 5 years among women undergoing sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral suspension for uterovaginal prolapse.

Study Design: This planned secondary analysis of a comparative effectiveness trial of 2 transvaginal apical suspensions (NCT01802281) defined surgical failure as either retreatment of prolapse, recurrence of prolapse beyond the hymen, or bothersome prolapse symptoms.

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Importance: Data on long-term mesh hysteropexy outcomes are limited. This study provides 7-year data from the original VAULT (Vaginal and Laparoscopic Mesh Hysteropexy for Uterovaginal Prolapse Trial) study.

Objective: The aim of this study was to compare long-term outcomes and success for laparoscopic sacral hysteropexy (LSHP) and vaginal mesh hysteropexy (VMHP).

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Importance: Pessaries are an important conservative therapy for stress urinary incontinence (SUI), but few studies have comprehensively evaluated their utility.

Objective: The objective of this study is to evaluate the existing evidence on the efficacy and safety of pessaries for the treatment of SUI.

Study Design: We searched for the terms "stress urinary incontinence" and "pessar/y/ies/ium" in PubMed, Embase, and Cinhal on June 10, 2020.

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Objective: To develop and perform a usability testing of a mobile application (app) with representative users of surgeons and female patients undergoing stress urinary incontinence (SUI) surgery.

Methods: A mobile app was developed with the Medical Device Epidemiology Network (MDEpiNet) High-Performance Integrated Virtual Environment (HIVE) to streamline the collection of patient-reported outcomes following SUI surgery using validated questionnaires. It was designed as a collaborative effort with the Women's Health Initiative (WHI), including patient and surgeon involvement.

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Study Objective: To determine the incidence of perioperative coronavirus disease (COVID-19) in women undergoing benign gynecologic surgery and to evaluate perioperative complication rates in patients with active, previous, or no previous severe acute respiratory syndrome coronavirus 2 infection.

Design: A multicenter prospective cohort study.

Setting: Ten institutions in the United States.

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Background: Prolapse recurrence after transvaginal surgical repair is common; however, its mechanisms are ill-defined. A thorough understanding of how and why prolapse repairs fail is needed to address their high rate of anatomic recurrence and to develop novel therapies to overcome defined deficiencies.

Objective: This study aimed to identify mechanisms and contributors of anatomic recurrence after vaginal hysterectomy with uterosacral ligament suspension (native tissue repair) vs transvaginal mesh (VM) hysteropexy surgery for uterovaginal prolapse.

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Background: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market.

Objective: Our objective was to compare the efficacy and adverse events of these 2 procedures.

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Objective: To assess whether resting genital hiatus, perineal body, and total vaginal length measured intraoperatively at the conclusion of surgery are associated with prolapse recurrence 2 years after native tissue pelvic organ prolapse reconstruction.

Methods: This ancillary analysis of the OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) trial included women who had an immediate postoperative pelvic organ prolapse quantification (POP-Q) examination and 2-year follow-up. Primary outcome was bothersome bulge symptoms.

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Introduction And Hypothesis: The protocol and analysis methods for the Defining Mechanisms of Anterior Vaginal Wall Descent (DEMAND) study are presented. DEMAND was designed to identify mechanisms and contributors of prolapse recurrence after two transvaginal apical suspension procedures for uterovaginal prolapse.

Methods: DEMAND is a supplementary cohort study of a clinical trial in which women with uterovaginal prolapse randomized to (1) vaginal hysterectomy with uterosacral ligament suspension or (2) vaginal mesh hysteropexy underwent pelvic magnetic resonance imaging (MRI) at 30-42 months post-surgery.

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Objective: To evaluate the longer-term safety and reintervention outcomes of mesh implants in pelvic organ prolapse (POP) repairs.

Methods: We conducted a population-based cohort study of women undergoing POP repairs in inpatient and outpatient surgical settings between 2008 and 2016 in New York State. Multivariable logistic regression was used based on patient and procedural characteristics and hospital volume between mesh and nonmesh groups to obtain propensity scores for each individual.

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Objective: The aim of the study was to compare 6-month efficacy and safety for treatment of vaginal dryness/genitourinary syndrome of menopause in women undergoing fractionated CO2 vaginal laser therapy to women using estrogen vaginal cream.

Methods: This multicenter, randomized trial compared fractionated CO2 laser to estrogen cream at 6 institutions. We included menopausal women with significant vaginal atrophy symptoms and we excluded women with prolapse below stage 2, recent pelvic surgery, prior mesh surgery, active genital infection, history of estrogen sensitive malignancy, and other autoimmune conditions.

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Importance: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option.

Objective: To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy.

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Background: Posterior repairs and perineorrhaphies are often performed in prolapse surgery to reduce the size of the genital hiatus. The benefit of an adjuvant posterior repair at the time of sacrospinous ligament fixation or uterosacral ligament suspension is unknown.

Objective: We aimed to determine whether an adjuvant posterior repair at transvaginal apical suspension is associated with improved surgical success.

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Objective: The aim of this study was to characterize clinical success, impact on quality of life, and durability up to 1 year in women with fecal incontinence (FI) responsive to an initial test period with a trial vaginal bowel control system.

Methods: This was a prospective open-label study in subjects with FI and successfully fit who underwent an initial 2-week trial period. Those achieving 50% or greater reduction in FI episodes were provided the long-term system.

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