Completed Studies

ABC

Anticholinergics versus Botox Comparison in Women with Urge Incontinence

The ABC study was designed to compare treatment with an anticholinergic medication (Solifenacin or Trospium) to a single Botox A® injection into the bladder. Half of the women in the study received the Botox A® injection and also took a daily placebo (no active medication) pill. The other half had an injection of a simple salt solution into the bladder and took a pill of Solifenacin or Trospium daily. Neither the women in the study nor their doctors or nurses knew which active treatment that they had received.

ATLAS

Ambulatory Treatments for Leakage Associated with Stress

The Ambulatory Treatments for Leakage Associated with Stress Incontinence (ATLAS) Trial was a study comparing 3 non-surgical approaches to the management of stress urinary incontinence, which is involuntary urine leakage with activities such as running, coughing and sneezing.

CAPS

Childbirth and Pelvic Symptoms

The Childbirth and Pelvic Symptoms (CAPS) study was a prospective cohort study performed by the Pelvic Floor Disorders Network to study postpartum fecal and urinary incontinence in primiparous women. The primary goal of the study was to estimate and compare the prevalence and incidence of postpartum urinary and fecal incontinence (UI and FI, respectively) in 3 cohorts of primiparous women: (1) those who had anal sphincter disruption during vaginal delivery; (2) a control group of women without clinically apparent anal sphincter disruption during delivery; and (3) a second control group who underwent a cesarean delivery without labor.

ESTEEM

Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence

The ESTEEM study was designed to study whether combining surgery and behavioral/pelvic floor therapy works better for treating MUI compared to having a sling alone.

ESTEEM-HMS

Human Microbiome Study for ESTEEM

The HMS-ESTEEM study will compare the bacterial environments of the bladder and vagina in women with mixed urinary incontinence who are enrolled in the ESTEEM trial with women (controls) who report that they do not experience urgency or stress incontinence.

MUSA

Mixed Urinary Incontinence: Mid-urethral Sling vs.
Botox A

The primary objective was to estimate the effect of intradetrusor injections Botulinum toxin A (Botox A ®) compared to mid-urethral sling for treatment of MUI in 146 women 6 months after treatment. The change in severity of MUI symptoms will be measured using the Urogenital Distress Inventory.
Secondary objectives include identifying predictors of treatment failure and cost-effectiveness of treatments in this MUI population.

MUSA-PRoMISe

Proteomics and Pathway Analysis of Women With Mixed Urinary Incontinence-MUSA Supplementary

The primary aim of the PRoMISe study is to characterize baseline putative proteins/protein pathways in women with MUI associated with change in UDI after treatment with MUS or onabotulinum toxin A (i.e., MUSA Trial original subjects, N=110).

ROSETTA

Refractory Overactive Bladder: Sacral Neuromodulation v. Botulinum Toxin Assessment

The ROSETTA study is a formal comparison of two treatments for urge urinary incontinence.The ROSETTA study compares the use of Botox A® (onabotulinumtoxin A) with sacral neuromodulation (also called InterStim® therapy).

RUBI

Refractory Idiopathic Urge Urinary Incontinence and Botulinum A Injection

For this study, the PFDN compared 200 U intradetrusor botulinum toxin A vs placebo in women with refractory idiopathic urge incontinence.

RUM

ROSETTA Urinary Marker

The purpose of this study is to characterize and evaluate the impact of 2 different treatment modalities (Interstim® and Botox A®) for refractory urgency urinary incontinence (UUI) on bladder inflammation and tissue remodeling manifested via biomarkers present in urine.

UUI-GWAS

Prevalent Urgency Urinary Incontinence Genome Wide Association

The purpose of this study is to perform a genome-wide association study in a well characterized cohort of post-reproductive women to identify genetic variants that are associated with prevalent urgency urinary incontinence.

ABBI

Adaptive Behaviors in Women with Bowel Incontinence

The Adaptive Behaviors in Women with Bowel Incontinence (ABBI) study was a multi-center observational study conducted at 7 centers within the Pelvic Floor Disorders Network. The goals of this protocol are to describe the use of adaptive behaviors among women presenting with fecal incontinence as the subject’s primary complaint and to validate the PFDN Adaptation Index as a measure of such behaviors in women with fecal continence.

AIMS

Anal Incontinence Measurement Scale

The investigators of the PFDN are designing a treatment trial for women with fecal incontinence, and recognized that there really isn’t a good questionnaire for women that they could use to measure differences before and after treatment. Although many questionnaires might exist, they are either not appropriate for these women, or they do not truly explore the symptoms that the investigators think are important to women struggling with accidental bowel leakage.

BOOST

Behavioral Therapy Of Obstetric Sphincter Tears

The Behavioral Therapy versus Usual Care in Primiparous Women with Anal Sphincter Tears and Fecal Incontinence Study, a collaborative cohort study with 8 site locations is designed to determine the postpartum incidence of fecal incontinence (FI) symptoms in primiparous women sustaining an obstetric anal sphincter injury (OASI). The recruitment for this study was completed in June 2011, and the participants are currently in a follow-up phase.

CAPABLe

Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide

The goal of the CAPABLe study is to learn more about the two specific treatments: medications and pelvic muscle training. Specifically, this study will compare the following treatments for fecal incontinence to see if one treatment or both together are better than usual care at improving fecal incontinence: Loperamide only, Pelvic muscle training only, Loperamide and pelvic muscle training together, or Usual care.

CAPS

Childbirth and Pelvic Symptoms

The Childbirth and Pelvic Symptoms (CAPS) study was a prospective cohort study performed by the Pelvic Floor Disorders Network to study postpartum fecal and urinary incontinence in primiparous women. The primary goal of the study was to estimate and compare the prevalence and incidence of postpartum urinary and fecal incontinence (UI and FI, respectively) in 3 cohorts of primiparous women: (1) those who had anal sphincter disruption during vaginal delivery; (2) a control group of women without clinically apparent anal sphincter disruption during delivery; and (3) a second control group who underwent a cesarean delivery without labor.

CAPS Imaging

Anatomic Characterization of the External/Internal Anal Sphincter at Six Months Postpartum

The purpose of the CAPS Imaging study was to determine if ultrasound can be used to identify more gaps or damage 6-12 months after vaginal delivery in women that had a sphincter tear at the time of delivery of their first baby than in women who did not have a sphincter tear. We also wished to see if these ultrasound findings were associated with fecal incontinence and its severity.

NOTABLE

Neuromodulation for Accidental Bowel Leakage

The NOTABLE study is part of the PFDN portfolio of clinical studies aimed at providing insights into treatment of fecal incontinence (FI) also referred to as accidental bowel leakage (ABL).

SMM-CAPABLe

Stool Metabolome and Microbiome in Women with Fecal Incontinence in CAPABLe

This study will investigate if in the stool microbiome and stool metabolome in women who experience bothersome bowel leakage is different from those in women who do not report this problem. We will also investigate if the amount of certain bacteria in the stool contributes to accidental bowel leakage or impacts the effectiveness of treatment.

ASPIRe

Apical Suspension Repair for Vault Prolapse

The purpose of the “ASPIRe” study was to find out how the results of the surgical procedures compare to each other as well as the advantages and/or disadvantages, risks and benefits, and the effect on quality of life of each surgery when used to repair vaginal vault (apical) prolapse. Physicians were able to choose from these different types of surgeries to repair vaginal vault (apical) prolapse, but there is not enough information or evidence that demonstrates which surgery provides the best symptom relief and durability while causing the fewest risks.

CARE

Colpopexy and Urinary Reduction Efforts

The Colpopexy and Urinary Reduction Efforts (CARE) study was designed to assess whether the addition of standardized Burch colposuspension to abdominal sacrocolpopexy for the treatment of pelvic-organ prolapse decreases postoperative stress urinary incontinence (SUI) in women without preoperative symptoms of stress incontinence.

Colpocleisis

Pelvic Symptoms and Patient Satisfaction After Colpocleisis

The Pelvic Symptoms and Patient Satisfaction After Colpocleisis (Colpocleisis) study was conducted to study the effect of colpocleisis on pelvic support, symptoms and quality of life (QOL) and report associated morbidity and postoperative satisfaction.

DEMAND

Defining Mechanisms of Anterior Vaginal Wall Descent

In this study, we will learn more about how surgery impacts the position of the vagina, bladder and bowel in the years following a SUPeR surgery. We will also learn about the durability of the SUPeR surgeries.

E-CARE

Extended Colpopexy and Urinary Reduction Efforts

The purpose of this study is to extend the follow up of women in the Colpopexy and Urinary Reduction Effort (CARE) study for up to 10 years from the time of their surgery. In this way, we will learn more about how prolapse repair surgery affects women over a long period of time.

E-OPTIMAL

Extended Follow-up of Patients Enrolled in OPTIMAL

The purpose of this study is to extend the follow-up of women in the OPTIMAL study up to 5 years from the time of surgery to compare the success and complication rates of the two surgical treatment groups over this extended time period.

FASt

Frailty ASPIRe Study

The purpose of the FASt study is to determine the impact of preoperative frailty and mobility on surgical treatment outcomes and postoperative complications of older women following surgical correction of apical pelvic organ prolapse (POP).

OPTIMAL

Operations and Pelvic Muscle Training in the Management of Apical Support Loss

The OPTIMAL study was designed to compare two commonly performed vaginal surgeries for pelvic organ prolapse. One is the sacrospinous ligament fixation, called SSLF for short. The other is the uterosacral ligament suspension, called ULS.

OPUS

Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling

The objective of the OPUS trial is to determine whether doing a vaginal anti-incontinence surgery at the time of vaginal prolapse surgery helps to cut down on urinary incontinence in women without stress urinary incontinence before surgery.

SUPeR

Study of Uterine Prolapse Procedures

The investigators of the Pelvic Floor Disorders Network have been very interested in comparing various treatments for prolapse in order to provide information that will help doctors develop the best treatment plan for their patients. The primary aim of SUPeR was to determine whether treatment success in women with symptomatic uterovaginal prolapse undergoing transvaginal mesh augmented hysteropexy differs in women undergoing vaginal hysterectomy and native tissue cuff suspension at time points through 3 years. The SUPeR participant population represents a unique opportunity to understand the longer term efficacy and safety outcomes of a native tissue repair and a mesh hysteropexy.

Voiding

Voiding Function in Women with Pelvic Organ Prolapse and Urinary Incontinence

The purpose of the Voiding study was to determine how pelvic organ prolapse impacts bladder and urethral function.

FOCUS

Participant Recruitment and Retention Focus Group

In FOCUS, the PFDN used a focus-group methodology to gather information about women's knowledge and attitudes regarding research participation.

PaPPR

Patient Perception of Postoperative Recovery

PaPPR is a supplemental study to characterize a patient’s assessment of postoperative recovery and to determine the optimal outcome measure to capture a patient’s quantitative assessment of postoperative recovery following minimally invasive surgery for apical prolapse via an individual virtual cognitive interview.

PASEo

The Patient Perspective on Adverse Surgical Events

The objective of this qualitative study was to describe patient perceptions on adverse events following surgery for pelvic floor disorders.