Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial.

Background: Well designed, large comparative effectiveness trials assessing the efficacy of primary interventions for faecal incontinence are few in number. The objectives of this study were to compare different combinations of anorectal manometry-assisted biofeedback, loperamide, education, and oral placebo.

Methods: In this randomised factorial trial, participants were recruited from eight clinical sites in the USA.

Models for Predicting Recurrence, Complications, and Health Status in Women After Pelvic Organ Prolapse Surgery.

Objective: To develop statistical models predicting recurrent pelvic organ prolapse, surgical complications, and change in health status 12 months after apical prolapse surgery.

Methods: Logistic regression models were developed using a combined cohort from three randomized trials and two prospective cohort studies from 1,301 participants enrolled in surgical studies conducted by the Pelvic Floor Disorders Network. Composite recurrent prolapse was defined as prolapse beyond the hymen; the presence of bothersome bulge symptoms; or prolapse reoperation or retreatment within 12 months after surgery.

Open sacrocolpopexy and vaginal apical repair: retrospective comparison of success and serious complications.

Introduction And Hypothesis: We compared treatment success and adverse events between women undergoing open abdominal sacrocolpopexy (ASC) vs vaginal repair (VAR) using data from women enrolled in one of three multicenter trials. We hypothesized that ASC would result in better outcomes than VAR.

Methods: Participants underwent apical repair of stage 2-4 prolapse.

Concomitant Anterior Repair, Preoperative Prolapse Severity, and Anatomic Prolapse Outcomes After Vaginal Apical Procedures.

Objective: The aim of the study was to compare anterior and overall prolapse prevalence at 1 year in surgical participants with or without concomitant anterior repair (AR) at the time of sacrospinous ligament fixation (SSLF) or uterosacral ligament suspension (ULS).

Methods: This is a secondary analysis of two surgical trials; concomitant AR was performed at surgeon's discretion. Anterior anatomic success was defined as pelvic organ prolapse quantification of prolapse point Ba ≤0 and overall success was defined as pelvic organ prolapse quantification points Ba, Bp, and C ≤0 at 12 months.

OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.

Importance: Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information.

Objective: To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence.

Design, Setting, And Participants: Multicenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence.

Cost-Effectiveness Analysis of Anticholinergics Versus Botox for Urgency Urinary Incontinence: Results From the Anticholinergic Versus Botox Comparison Randomized Trial.

Objectives: This study aimed to compare the cost-effectiveness of Botox and anticholinergic (AC) medications for the management of urgency urinary incontinence (UUI).

Methods: Cost and effectiveness data were analyzed from participants in the Anticholinergic versus Botox Comparison randomized trial of daily AC medication versus 100 U of intradetrusor Botox injection. Societal costs included the following: treatment costs, patient costs, and medical and nonmedical utilization during the 6-month trial.

The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial).

Objectives: We present the rationale for and design of a randomized controlled superiority trial comparing 2 vaginal surgical approaches for the treatment of uterovaginal prolapse. The Study of Uterine Prolapse Procedures Randomized Trial (SUPeR) trial compares the efficacy and safety of native tissue repair with vaginal hysterectomy and suture apical suspension versus uterine conservation with mesh hysteropexy through 36 to 60 months postoperatively for primary repair of uterovaginal prolapse.

Methods: The selection of the primary outcome measure, timing of randomization, patient and evaluator masking to surgical intervention, collection and adjudication of adverse events, cost effectiveness evaluations, partnering with industry, and surgeon certification of competency to perform the 2 procedures is described.

Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.

The goals of this trial are to determine the efficacy and safety of two treatments for women experiencing fecal incontinence. First, we aim to compare the use of loperamide to placebo and second, to compare the use of anal sphincter exercises with biofeedback to usual care. The primary outcome is the change from baseline in the St.

The female urinary microbiome in urgency urinary incontinence.

Objective: The purpose of this study was to characterize the urinary microbiota in women who are planning treatment for urgency urinary incontinence and to describe clinical associations with urinary symptoms, urinary tract infection, and treatment outcomes.

Study Design: Catheterized urine samples were collected from multisite randomized trial participants who had no clinical evidence of urinary tract infection; 16S ribosomal RNA gene sequencing was used to dichotomize participants as either DNA sequence-positive or sequence-negative. Associations with demographics, urinary symptoms, urinary tract infection risk, and treatment outcomes were determined.

Incidence and Predictors of Anal Incontinence After Obstetric Anal Sphincter Injury in Primiparous Women.

Objective: This study aimed to describe the incidence of fecal incontinence (FI) at 6, 12, and 24 weeks postpartum; anal incontinence (AI) and fecal urgency at 24 weeks; and identify predictors of AI in women with obstetric anal sphincter injury (OASI).

Methods: Primiparous women sustaining OASIs were identified at 8 clinical sites. Third-degree OASIs were characterized using World Health Organization criteria, 3a (<50%) or 3b (>50%) tear through the sphincter.

Symptom outcomes important to women with anal incontinence: a conceptual framework.

Objective: To develop a framework that describes the most important symptom outcomes for anal incontinence treatment from the patient perspective.

Methods: A conceptual framework was developed by the Pelvic Floor Disorders Network based on four semistructured focus groups and confirmed in two sets of 10 cognitive interviews including women with anal incontinence. We explored: 1) patient-preferred terminology for describing anal incontinence symptoms; 2) patient definitions of treatment "success"; 3) importance of symptoms and outcomes in the framework; and 4) conceptual gaps (defined as outcomes not previously identified as important).

Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial.

Importance: More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery.

A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery.

Objective: To construct and validate a prediction model for estimating the risk of de novo stress urinary incontinence (SUI) after vaginal pelvic organ prolapse (POP) surgery and compare it with predictions using preoperative urinary stress testing and expert surgeons' predictions.

Materials And Methods: Using the data set (n=457) from the Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial, a model using 12 clinical preoperative predictors of de novo SUI was constructed. De novo SUI was determined by Pelvic Floor Distress Inventory responses through 12 months postoperatively.

Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence.

Background: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed.

Methods: We performed a double-blind, double-placebo-controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo.

A midurethral sling to reduce incontinence after vaginal prolapse repair.

Background: Women without stress urinary incontinence undergoing vaginal surgery for pelvic-organ prolapse are at risk for postoperative urinary incontinence. A midurethral sling may be placed at the time of prolapse repair to reduce this risk.

Methods: We performed a multicenter trial involving women without symptoms of stress incontinence and with anterior prolapse (of stage 2 or higher on a Pelvic Organ Prolapse Quantification system examination) who were planning to undergo vaginal prolapse surgery.

Complications of common gynecologic surgeries among HIV-infected women in the United States.

Objective: To compare frequencies of complications among HIV-infected and-uninfected women undergoing common gynecological surgical procedures in inpatient settings.

Methods: We used 1994-2007 data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project, a nationally representative sample of inpatient hospitalizations. Our analysis included discharge records of women aged ≥15 undergoing hysterectomy, oophorectomy, salpingectomy for ectopic pregnancy, bilateral tubal sterilization, or dilation and curettage.

Pelvic floor disorders clinical trials: participant recruitment and retention.

Introduction And Hypothesis: We used a focus-group methodology to gather information about women's knowledge and attitudes regarding research participation.

Methods: Two in-person focus groups at seven clinical sites were conducted in women with pelvic floor disorder (PFD): one of women with clinical trial study experience and the other without such experience. One Web-based focus group combining both groups was also conducted.

Poisoning hospitalisations among reproductive-aged women in the USA, 1998-2006.

Objective: To describe poisoning hospitalisations among reproductive-aged women from 1998 to 2006.

Methods: 1998-2006 data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilisation Project were used to identify hospitalisations for poisonings among US women aged 15-44 years. Differences in hospitalisation characteristics were compared by intent using χ(2) statistics.

Maternal and fetal outcomes among women with depression.

Objective: To compare maternal and fetal outcomes among women with and without diagnosed depression at the time of delivery.

Methods: Hospital discharge data from the 1998-2005 Nationwide Inpatient Sample (NIS) were used to examine delivery-related hospitalizations for select maternal and fetal outcomes by depression diagnosis.

Results: The rate of depression per 1000 deliveries increased significantly from 2.

Severe obstetric morbidity in the United States: 1998-2005.

Objective: To examine trends in the rates of severe obstetric complications and the potential contribution of changes in delivery mode and maternal characteristics to these trends.

Methods: We performed a cross-sectional study of severe obstetric complications identified from the 1998-2005 Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project. Logistic regression was used to examine the effect of changes in delivery mode and maternal characteristics on rates of severe obstetric complications.

An enhanced method for identifying obstetric deliveries: implications for estimating maternal morbidity.

Objectives: The accuracy of maternal morbidity estimates from hospital discharge data may be influenced by incomplete identification of deliveries. In maternal/infant health studies, obstetric deliveries are often identified only by the maternal outcome of delivery code (International Classification of Diseases code = V27). We developed an enhanced delivery identification method based on additional delivery-related codes and compared the performance of the enhanced method with the V27 method in identifying estimates of deliveries as well as estimates of maternal morbidity.

Children with sickle cell disease and human immunodeficiency virus-1 infection: use of inpatient care services in the United States.

Background: The purpose of this study was to describe hospital use patterns of children with sickle cell disease (SCD) and human immunodeficiency virus type-1 (HIV) infection in the United States.

Methods: Hospital discharges of children with 1 or both of the 2 conditions (SCD and HIV infection) were analyzed using nationally weighted data from the 1994 to 2003 Nationwide Inpatient Databases of the Healthcare Cost and Utilization Project. Demographic and hospital characteristics, length of stay, charges and the most frequent diagnoses and procedures performed during the hospitalization were compared.

Injury hospitalizations of pregnant women in the United States, 2002.

Objective: To estimate the number of injury-related hospitalizations of pregnant women in the United States and to identify injury mechanisms associated with hospitalizations that end in delivery.

Study Design: Using data on injury hospitalizations of pregnant women from the 2002 Healthcare Cost and Utilization Project Nationwide Inpatient Sample, we compared the mechanism of injuries of nondelivery hospitalizations with those of delivery hospitalizations.

Results: Of an estimated 16,982 injury hospitalizations involving pregnant women in 2002, a delivery occurred in 37.

Incidence and determinants of peripartum hysterectomy.

Objective: Most studies of peripartum hysterectomy are conducted in single institutions, limiting the ability to provide national incidence estimates and examine risk factors. The objective of this study was to provide a national estimate of the incidence of peripartum hysterectomy and to examine factors associated with the procedure.

Methods: We used data for 1998-2003 from the Healthcare Cost and Utilization Project Nationwide Inpatient Sample, an annual nationally representative survey of inpatient hospitalizations.