Joseph Schaffer | University of Texas Southwestern Medical Center at Dallas (original) (raw)

Papers by Joseph Schaffer

International urogynecology journal, Aug 25, 2018

We compared treatment success and adverse events between women undergoing open abdominal sacrocol... more 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. Participants underwent apical repair of stage 2-4 prolapse. Vaginal repair included uterosacral, sacrospinous, and iliococcygeal suspensions; sacrocolpopexies were via laparotomy. Success was defined as no bothersome bulge symptoms, no prolapse beyond the hymen, and no retreatment up to 24 months. Adverse events were collected at multiple time points. Outcomes were analyzed using longitudinal mixed-effects models to obtain valid outcome estimates at specific visit times, accounting for data missing at random. Comparisons were controlled for center, age, body mass index (BMI), initial Pelvic Organ Prolapse Quantification (POP-Q) stage, baseline scores, prior prolapse repair, and concurrent repairs. Of women who met inclu...

American Journal of Obstetrics and Gynecology, 2021

BACKGROUND The ideal measure of success after surgery for pelvic organ prolapse (POP) has long be... more BACKGROUND The ideal measure of success after surgery for pelvic organ prolapse (POP) has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes are equally or more important when comparing the success of various prolapse surgeries. Understanding the limitations of existing outcome definitions will guide surgical outcome reporting and comparisons of POP surgeries. OBJECTIVES To describe the relationships and overlap between participants who met anatomic, subjective, and retreatment definitions of success or failure after POP surgery; demonstrate rates of transition between success and failure over time; and compare scores from the Pelvic Organ Prolapse Distress Inventory (POPDI), Short-Form Six-Dimension health index (SF-6D), and quality-adjusted life years (QALYs) between these definitions. STUDY DESIGN Definitions of surgical success were evaluated at 3 or 6, 12, 24, 36, 48, and 60 months after surgery for ≥ stage II POP in a cohort of women (N=1,250) from four randomized clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical failure was defined by composite measure requiring: 1) anatomic failure (POPQ Ba, Bp or C > 0); 2) subjective failure (presence of bothersome vaginal bulge symptoms); or 3) pessary or surgical retreatment for POP. POPDI, SF-6D and QALYs were compared between participants who met a variety of definitions of success and failure including novel "intermittent" success/failure over time. RESULTS Among the 433/1,250 (34.6%) women who had surgical failure outcomes at ≥1 timepoint, 85.5% (370/433) met only one component of the composite outcome at assessment of initial failure (anatomic failure = 46.7%, 202/433; subjective failure = 36.7%, 159/433; retreatment = 2.1%, 9/433). Only 12.9% (56/433) met criteria for both for anatomic and subjective failure. Despite meeting the criteria for failure in primary study reporting, 24.2% (105/433) of these transitioned between success and failure during follow-up, and 83.8% (88/105) of these intermittent success/failures met criteria for success at their last follow-up. There were significant associations between success/failure group and the 1- and 2- year QALYs as well as a time-varying group effect on POPDI and SF-6D scores. CONCLUSIONS True failure rates after prolapse surgery may be overestimated in the current literature. Only 13% of clinical trial subjects initially met both subjective and objective criteria for failure. Approximately one-quarter of failures were intermittent and transitioned between success and failure over time, with the majority of intermittent failures being in a state of 'surgical success' at their last follow-up. Current composite definitions of success or failure may result in overestimation of surgical failure rates, potentially explaining, in part, the discordance with low retreatment rates after POP surgery.

International Urogynecology …, 2004

The suburethral sling with tension-free vaginal tape (TVT) has become a popular treatment for str... more The suburethral sling with tension-free vaginal tape (TVT) has become a popular treatment for stress urinary incontinence. Erosion of the mesh into the urethra is rare, usually presenting with hematuria, pain, voiding dysfunction or urge incontinence. A patient with stress incontinence was treated with a TVT suburethral sling. One month later, symptoms of recurrent stress incontinence developed. Cystourethroscopy revealed urethral mesh erosion. Surgical removal involved cystourethroscopic-assisted transurethral resection of the mesh, followed by vaginal dissection and periurethral withdrawal. Urethral mesh erosion should be considered in a patient who presents with atypical symptoms after being treated with a suburethral sling. It is important to obtain a detailed history and have a high clinical index of suspicion for erosion. Careful and comprehensive urethroscopy, in addition to cystoscopy, should be a mandatory part of the TVT procedure. Further study is needed to determine the optimal technique for mesh removal.

Female Pelvic Medicine & Reconstructive Surgery, 2011

OBJECTIVES: (1) to describe sexual function in women seeking treatment of stress urinary incontin... more OBJECTIVES: (1) to describe sexual function in women seeking treatment of stress urinary incontinence (SUI); (2) to compare the impact on sexual function of three SUI treatments; and (3) to investigate whether non-surgical treatment of SUI is associated with improved sexual function. METHODS: Women with SUI were randomized to continence pessary, behavioral therapy (pelvic floor muscle training and continence strategies), or combination therapy. Sexual function was assessed at baseline and 3-months using short forms of the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-12) and the Personal Experiences Questionnaire (SPEQ). Successful treatment of SUI was assessed with a patient global impression of improvement. ANOVA was used to compare scores between groups. RESULTS: At baseline, sexual function was worse among women with mixed incontinence compared to those with pure SUI. After therapy, successful treatment of SUI was associated with greater improvement in PISQ-12 score (2.26 ± 3.24 versus 0.48 ± 3.76, p=0.0007), greater improvement in incontinence with sexual activity (0.45 ± 0.84 versus 0.01 ± 0.71, p=0.0002), and greater reduction in restriction in sexual activity related to fear of incontinence (0.32 ± 0.76 versus -0.06 ± 0.78, p=0.0008). Among those successfully treated for SUI, improvement in continence during sexual activity was greater in both the combined therapy group (p=0.019) and the behavioral group (p=0.02) compared to the pessary group. CONCLUSIONS: Successful non-surgical treatment of SUI is associated with improvements in incontinence-specific measures of sexual function. Behavioral therapy may be preferred to pessary for treatment of SUI among women whose incontinence interferes with sexual function.

The New England journal of medicine, Jan 3, 2010

Midurethral slings are increasingly used for the treatment of stress incontinence, but there are ... more Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rat...

Obstetrics and gynecology, 2012

To identify factors that may predict success and satisfaction in women undergoing nonsurgical the... more To identify factors that may predict success and satisfaction in women undergoing nonsurgical therapy for stress urinary incontinence. Baseline demographic and clinical characteristics of women participating in a multicenter randomized trial of pessary, behavioral, or combined therapy for stress urinary incontinence were evaluated for potential predictors of success and satisfaction. Success and satisfaction outcomes were assessed at 3 months and included the Patient Global Impression of Improvement, stress incontinence subscale of the Pelvic Floor Distress Inventory, and Patient Satisfaction Questionnaire. Logistic regression was performed to identify predictors, adjusting for treatment and other important clinical covariates. Adjusted odds ratios (ORs), 95% confidence intervals (CIs), and associated P values are presented. Four hundred forty-six women were randomized. College education or more and no previous urinary incontinence surgery predicted success based on the stress subsc...

JAMA, Jan 12, 2014

More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse... more 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. To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. Multicenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%. The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 18...

New England Journal of Medicine, 2012

Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence... more Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. 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. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001). Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; ClinicalTrials.gov number, NCT01166438.).

New England Journal of Medicine, 2010

Journal of Minimally Invasive Gynecology, 2014

The Society of Gynecologic Surgeons Systematic Review Group performed a systematic review of both... more The Society of Gynecologic Surgeons Systematic Review Group performed a systematic review of both randomized and observational studies to compare robotic vs nonrobotic surgical approaches (laparoscopic, abdominal, and vaginal) for treatment of both benign and malignant gynecologic indications to compare surgical and patient-centered outcomes, costs, and adverse events associated with the various surgical approaches. MEDLINE and the Cochrane Central Register of Controlled Trials were searched from inception to May 15, 2012, for English-language studies with terms related to robotic surgery and gynecology. Studies of any design that included at least 30 women who had undergone robotic-assisted laparoscopic gynecologic surgery were included for review. The literature yielded 1213 citations, of which 97 full-text articles were reviewed. Forty-four studies (30 comparative and 14 noncomparative) met eligibility criteria. Study data were extracted into structured electronic forms and reconciled by a second, independent reviewer. Our analysis revealed that, compared with open surgery, robotic surgery consistently confers shorter hospital stay. The proficiency plateau seems to be lower for robotic surgery than for conventional laparoscopy. Of the various gynecologic applications, there seems to be evidence that renders robotic techniques advantageous over traditional open surgery for management of endometrial cancer. However, insofar as superiority, conflicting data are obtained when comparing robotics vs laparoscopic techniques. Therefore, the specific method of minimally invasive surgery, whether conventional laparoscopy or robotic surgery, should be tailored to patient selection, surgeon ability, and equipment availability.

Journal of Clinical Epidemiology, 2011

Objectives-(1) To systematically collect and organize into clinical categories all outcomes repor... more Objectives-(1) To systematically collect and organize into clinical categories all outcomes reported in trials for abnormal uterine bleeding (AUB); (2) to rank the importance of outcomes for patient decision making; and (3) to improve future comparisons of effects in trials of AUB interventions.

JAMA, 2008

Context Pelvic floor disorders (urinary incontinence, fecal incontinence, and pelvic organ prolap... more Context Pelvic floor disorders (urinary incontinence, fecal incontinence, and pelvic organ prolapse) affect many women. No national prevalence estimates derived from the same population-based sample exists for multiple pelvic floor disorders in women in the United States.

International Urogynecology Journal, 2009

Introduction and hypothesis The purpose of this study is to validate Spanish versions of the Pelv... more Introduction and hypothesis The purpose of this study is to validate Spanish versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Methods Spanish versions were developed using back translation and validation was performed by randomizing bilingual women to complete the Spanish or English versions of the questionnaires first. Weighted kappa statistics assessed agreement for individual questions; interclass correlation coefficients (ICC) compared primary and subscale scores. Cronbach's alpha assessed internal consistency of Spanish versions. To detect a 2.7 point difference in scores with 80% power and alpha of 0.05, 44 bilingual subjects were required. Results Individual questions showed good to excellent agreement (kappa>0.6) for all but eight questions on the PFIQ. ICCs of primary and subscale scores for both questionnaires showed excellent agreement. (All ICC> 0.79). All Cronbach's alpha values were excellent (>0.84) for the primary scales of both questionnaires. Conclusions Valid and reliable Spanish versions of the PFIQ and PFDI have been developed.

International Urogynecology Journal, 2014

Urinary bacteria in adult women with urgency urinary incontinence so. The median qPCR level for q... more Urinary bacteria in adult women with urgency urinary incontinence so. The median qPCR level for qPCR-positive samples did not differ significantly by UTI status (UTI 2.58×10 5 vs no UTI 1.35×10 5 copies/mL, p=0.6). Conclusions These results may indicate a urinary bacterial contribution to both baseline UUI and the risk of posttreatment UTI.

Contemporary Clinical Trials, 2009

The primary aims of this trial are: 1) to compare surgical outcomes following sacrospinous ligame... more The primary aims of this trial are: 1) to compare surgical outcomes following sacrospinous ligament fixation to uterosacral vaginal vault suspension in women undergoing vaginal surgery for apical or uterine pelvic organ prolapse and stress urinary incontinence and 2) to examine the effects of a structured perioperative program consisting of behavioral techniques and pelvic floor muscle training compared to usual care. This trial is performed through the Pelvic Floor Disorders Network (PFDN), which is funded by National Institute of Child Health and Human Development. Subjects will be enrolled from hospitals associated with seven PFDN clinical centers across the United States. A centralized biostatistical coordinating center will oversee data collection and analysis. Two approaches will be investigated simultaneously using a 2×2 randomized factorial design: a surgical intervention (sacrospinous ligament fixation versus uterosacral vaginal vault suspension) and a perioperative behavioral intervention (behavioral and pelvic floor muscle training versus usual care). Surgeons have standardized essential components of each surgical procedure and have met specific standards of expertise. Providers of the behavioral intervention have undergone standardized training. Anatomic, functional, and health-related quality of life outcomes will be assessed using validated measures by researchers blinded to all randomization assignments. Cost-effectiveness analysis will be performed using prospectively collected data on health care costs and resource utilization. The primary surgical endpoint is a composite outcome defined by anatomic recurrence, recurrence of bothersome vaginal prolapse symptoms and/or retreatment and will be assessed 2 years after the index surgery. Endpoints for the behavioral intervention include both short-term (6-month) improvement in urinary symptoms and long-term (2-year) improvement in anatomic outcomes and prolapse symptoms. This article describes the rationale and design of this randomized trial, focusing on several key design features of potential interest to researchers in the field of female pelvic floor disorders and others conducting randomized surgical trials.

Contemporary Clinical Trials, 2012

This trial compares the change in urgency urinary incontinence episodes over 6 months, tolerabili... more This trial compares the change in urgency urinary incontinence episodes over 6 months, tolerability and cost effectiveness between women receiving daily anticholinergic therapy plus a single intra-detrusor injection of saline versus a single intra-detrusor injection of 100 unit of botulinum toxin A plus daily oral placebo tablets. We present the rationale and design of a randomized controlled trial, Anticholinergic versus Botulinum Toxin, Comparison Trial for the Treatment of Bothersome Urge Urinary Incontinence: ABC Trial, conducted by the NICHD-funded Pelvic Floor Disorders Network. We discuss the innovative nature of this trial and the challenges related to choice of patient population, maintaining masking, cost-effectiveness, ethical considerations, measuring adherence, and placebo development and testing. Enrollment began in April, 2010. 242 participants will be randomized and primary outcome data analysis is anticipated to begin in mid 2012. Several challenges in the trial design are discussed. Randomization to placebo intradetrusor injections may limit recruitment, potentially impacting generalizability. Other challenges included the heavy marketing of drugs for overactive bladder which could impact recruitment of drug naïve women. In addition, anticholinergic medications often cause dry mouth, making masking difficult. Finally, adverse reporting of transient urinary retention is challenging as there is no standardized definition; yet this is the most common adverse event following intradetrusor botulinum toxin injection. The ABC trial will help women with urgency urinary incontinence balance efficacy, side effects and cost of anticholinergic medication versus botulinum toxin intradetrusor injection. The results have the potential to fundamentally change the therapeutic approach to this condition.

American Journal of Obstetrics and Gynecology, 2010

Objectives-This analysis compared 3 continuous variables as summary support loss scores with POPQ... more Objectives-This analysis compared 3 continuous variables as summary support loss scores with POPQ ordinal stages.

American Journal of Obstetrics and Gynecology, 2008

Objectives-To identify risks for mesh/suture erosions following sacrocolpopexy (ASC).

Obstetrics & Gynecology, 2010

International urogynecology journal, Aug 25, 2018

We compared treatment success and adverse events between women undergoing open abdominal sacrocol... more 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. Participants underwent apical repair of stage 2-4 prolapse. Vaginal repair included uterosacral, sacrospinous, and iliococcygeal suspensions; sacrocolpopexies were via laparotomy. Success was defined as no bothersome bulge symptoms, no prolapse beyond the hymen, and no retreatment up to 24 months. Adverse events were collected at multiple time points. Outcomes were analyzed using longitudinal mixed-effects models to obtain valid outcome estimates at specific visit times, accounting for data missing at random. Comparisons were controlled for center, age, body mass index (BMI), initial Pelvic Organ Prolapse Quantification (POP-Q) stage, baseline scores, prior prolapse repair, and concurrent repairs. Of women who met inclu...

American Journal of Obstetrics and Gynecology, 2021

BACKGROUND The ideal measure of success after surgery for pelvic organ prolapse (POP) has long be... more BACKGROUND The ideal measure of success after surgery for pelvic organ prolapse (POP) has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes are equally or more important when comparing the success of various prolapse surgeries. Understanding the limitations of existing outcome definitions will guide surgical outcome reporting and comparisons of POP surgeries. OBJECTIVES To describe the relationships and overlap between participants who met anatomic, subjective, and retreatment definitions of success or failure after POP surgery; demonstrate rates of transition between success and failure over time; and compare scores from the Pelvic Organ Prolapse Distress Inventory (POPDI), Short-Form Six-Dimension health index (SF-6D), and quality-adjusted life years (QALYs) between these definitions. STUDY DESIGN Definitions of surgical success were evaluated at 3 or 6, 12, 24, 36, 48, and 60 months after surgery for ≥ stage II POP in a cohort of women (N=1,250) from four randomized clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical failure was defined by composite measure requiring: 1) anatomic failure (POPQ Ba, Bp or C > 0); 2) subjective failure (presence of bothersome vaginal bulge symptoms); or 3) pessary or surgical retreatment for POP. POPDI, SF-6D and QALYs were compared between participants who met a variety of definitions of success and failure including novel "intermittent" success/failure over time. RESULTS Among the 433/1,250 (34.6%) women who had surgical failure outcomes at ≥1 timepoint, 85.5% (370/433) met only one component of the composite outcome at assessment of initial failure (anatomic failure = 46.7%, 202/433; subjective failure = 36.7%, 159/433; retreatment = 2.1%, 9/433). Only 12.9% (56/433) met criteria for both for anatomic and subjective failure. Despite meeting the criteria for failure in primary study reporting, 24.2% (105/433) of these transitioned between success and failure during follow-up, and 83.8% (88/105) of these intermittent success/failures met criteria for success at their last follow-up. There were significant associations between success/failure group and the 1- and 2- year QALYs as well as a time-varying group effect on POPDI and SF-6D scores. CONCLUSIONS True failure rates after prolapse surgery may be overestimated in the current literature. Only 13% of clinical trial subjects initially met both subjective and objective criteria for failure. Approximately one-quarter of failures were intermittent and transitioned between success and failure over time, with the majority of intermittent failures being in a state of 'surgical success' at their last follow-up. Current composite definitions of success or failure may result in overestimation of surgical failure rates, potentially explaining, in part, the discordance with low retreatment rates after POP surgery.

International Urogynecology …, 2004

The suburethral sling with tension-free vaginal tape (TVT) has become a popular treatment for str... more The suburethral sling with tension-free vaginal tape (TVT) has become a popular treatment for stress urinary incontinence. Erosion of the mesh into the urethra is rare, usually presenting with hematuria, pain, voiding dysfunction or urge incontinence. A patient with stress incontinence was treated with a TVT suburethral sling. One month later, symptoms of recurrent stress incontinence developed. Cystourethroscopy revealed urethral mesh erosion. Surgical removal involved cystourethroscopic-assisted transurethral resection of the mesh, followed by vaginal dissection and periurethral withdrawal. Urethral mesh erosion should be considered in a patient who presents with atypical symptoms after being treated with a suburethral sling. It is important to obtain a detailed history and have a high clinical index of suspicion for erosion. Careful and comprehensive urethroscopy, in addition to cystoscopy, should be a mandatory part of the TVT procedure. Further study is needed to determine the optimal technique for mesh removal.

Female Pelvic Medicine & Reconstructive Surgery, 2011

OBJECTIVES: (1) to describe sexual function in women seeking treatment of stress urinary incontin... more OBJECTIVES: (1) to describe sexual function in women seeking treatment of stress urinary incontinence (SUI); (2) to compare the impact on sexual function of three SUI treatments; and (3) to investigate whether non-surgical treatment of SUI is associated with improved sexual function. METHODS: Women with SUI were randomized to continence pessary, behavioral therapy (pelvic floor muscle training and continence strategies), or combination therapy. Sexual function was assessed at baseline and 3-months using short forms of the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-12) and the Personal Experiences Questionnaire (SPEQ). Successful treatment of SUI was assessed with a patient global impression of improvement. ANOVA was used to compare scores between groups. RESULTS: At baseline, sexual function was worse among women with mixed incontinence compared to those with pure SUI. After therapy, successful treatment of SUI was associated with greater improvement in PISQ-12 score (2.26 ± 3.24 versus 0.48 ± 3.76, p=0.0007), greater improvement in incontinence with sexual activity (0.45 ± 0.84 versus 0.01 ± 0.71, p=0.0002), and greater reduction in restriction in sexual activity related to fear of incontinence (0.32 ± 0.76 versus -0.06 ± 0.78, p=0.0008). Among those successfully treated for SUI, improvement in continence during sexual activity was greater in both the combined therapy group (p=0.019) and the behavioral group (p=0.02) compared to the pessary group. CONCLUSIONS: Successful non-surgical treatment of SUI is associated with improvements in incontinence-specific measures of sexual function. Behavioral therapy may be preferred to pessary for treatment of SUI among women whose incontinence interferes with sexual function.

The New England journal of medicine, Jan 3, 2010

Midurethral slings are increasingly used for the treatment of stress incontinence, but there are ... more Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rat...

Obstetrics and gynecology, 2012

To identify factors that may predict success and satisfaction in women undergoing nonsurgical the... more To identify factors that may predict success and satisfaction in women undergoing nonsurgical therapy for stress urinary incontinence. Baseline demographic and clinical characteristics of women participating in a multicenter randomized trial of pessary, behavioral, or combined therapy for stress urinary incontinence were evaluated for potential predictors of success and satisfaction. Success and satisfaction outcomes were assessed at 3 months and included the Patient Global Impression of Improvement, stress incontinence subscale of the Pelvic Floor Distress Inventory, and Patient Satisfaction Questionnaire. Logistic regression was performed to identify predictors, adjusting for treatment and other important clinical covariates. Adjusted odds ratios (ORs), 95% confidence intervals (CIs), and associated P values are presented. Four hundred forty-six women were randomized. College education or more and no previous urinary incontinence surgery predicted success based on the stress subsc...

JAMA, Jan 12, 2014

More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse... more 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. To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. Multicenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%. The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 18...

New England Journal of Medicine, 2012

Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence... more Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. 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. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001). Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; ClinicalTrials.gov number, NCT01166438.).

New England Journal of Medicine, 2010

Journal of Minimally Invasive Gynecology, 2014

The Society of Gynecologic Surgeons Systematic Review Group performed a systematic review of both... more The Society of Gynecologic Surgeons Systematic Review Group performed a systematic review of both randomized and observational studies to compare robotic vs nonrobotic surgical approaches (laparoscopic, abdominal, and vaginal) for treatment of both benign and malignant gynecologic indications to compare surgical and patient-centered outcomes, costs, and adverse events associated with the various surgical approaches. MEDLINE and the Cochrane Central Register of Controlled Trials were searched from inception to May 15, 2012, for English-language studies with terms related to robotic surgery and gynecology. Studies of any design that included at least 30 women who had undergone robotic-assisted laparoscopic gynecologic surgery were included for review. The literature yielded 1213 citations, of which 97 full-text articles were reviewed. Forty-four studies (30 comparative and 14 noncomparative) met eligibility criteria. Study data were extracted into structured electronic forms and reconciled by a second, independent reviewer. Our analysis revealed that, compared with open surgery, robotic surgery consistently confers shorter hospital stay. The proficiency plateau seems to be lower for robotic surgery than for conventional laparoscopy. Of the various gynecologic applications, there seems to be evidence that renders robotic techniques advantageous over traditional open surgery for management of endometrial cancer. However, insofar as superiority, conflicting data are obtained when comparing robotics vs laparoscopic techniques. Therefore, the specific method of minimally invasive surgery, whether conventional laparoscopy or robotic surgery, should be tailored to patient selection, surgeon ability, and equipment availability.

Journal of Clinical Epidemiology, 2011

Objectives-(1) To systematically collect and organize into clinical categories all outcomes repor... more Objectives-(1) To systematically collect and organize into clinical categories all outcomes reported in trials for abnormal uterine bleeding (AUB); (2) to rank the importance of outcomes for patient decision making; and (3) to improve future comparisons of effects in trials of AUB interventions.

JAMA, 2008

Context Pelvic floor disorders (urinary incontinence, fecal incontinence, and pelvic organ prolap... more Context Pelvic floor disorders (urinary incontinence, fecal incontinence, and pelvic organ prolapse) affect many women. No national prevalence estimates derived from the same population-based sample exists for multiple pelvic floor disorders in women in the United States.

International Urogynecology Journal, 2009

Introduction and hypothesis The purpose of this study is to validate Spanish versions of the Pelv... more Introduction and hypothesis The purpose of this study is to validate Spanish versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Methods Spanish versions were developed using back translation and validation was performed by randomizing bilingual women to complete the Spanish or English versions of the questionnaires first. Weighted kappa statistics assessed agreement for individual questions; interclass correlation coefficients (ICC) compared primary and subscale scores. Cronbach's alpha assessed internal consistency of Spanish versions. To detect a 2.7 point difference in scores with 80% power and alpha of 0.05, 44 bilingual subjects were required. Results Individual questions showed good to excellent agreement (kappa>0.6) for all but eight questions on the PFIQ. ICCs of primary and subscale scores for both questionnaires showed excellent agreement. (All ICC> 0.79). All Cronbach's alpha values were excellent (>0.84) for the primary scales of both questionnaires. Conclusions Valid and reliable Spanish versions of the PFIQ and PFDI have been developed.

International Urogynecology Journal, 2014

Urinary bacteria in adult women with urgency urinary incontinence so. The median qPCR level for q... more Urinary bacteria in adult women with urgency urinary incontinence so. The median qPCR level for qPCR-positive samples did not differ significantly by UTI status (UTI 2.58×10 5 vs no UTI 1.35×10 5 copies/mL, p=0.6). Conclusions These results may indicate a urinary bacterial contribution to both baseline UUI and the risk of posttreatment UTI.

Contemporary Clinical Trials, 2009

The primary aims of this trial are: 1) to compare surgical outcomes following sacrospinous ligame... more The primary aims of this trial are: 1) to compare surgical outcomes following sacrospinous ligament fixation to uterosacral vaginal vault suspension in women undergoing vaginal surgery for apical or uterine pelvic organ prolapse and stress urinary incontinence and 2) to examine the effects of a structured perioperative program consisting of behavioral techniques and pelvic floor muscle training compared to usual care. This trial is performed through the Pelvic Floor Disorders Network (PFDN), which is funded by National Institute of Child Health and Human Development. Subjects will be enrolled from hospitals associated with seven PFDN clinical centers across the United States. A centralized biostatistical coordinating center will oversee data collection and analysis. Two approaches will be investigated simultaneously using a 2×2 randomized factorial design: a surgical intervention (sacrospinous ligament fixation versus uterosacral vaginal vault suspension) and a perioperative behavioral intervention (behavioral and pelvic floor muscle training versus usual care). Surgeons have standardized essential components of each surgical procedure and have met specific standards of expertise. Providers of the behavioral intervention have undergone standardized training. Anatomic, functional, and health-related quality of life outcomes will be assessed using validated measures by researchers blinded to all randomization assignments. Cost-effectiveness analysis will be performed using prospectively collected data on health care costs and resource utilization. The primary surgical endpoint is a composite outcome defined by anatomic recurrence, recurrence of bothersome vaginal prolapse symptoms and/or retreatment and will be assessed 2 years after the index surgery. Endpoints for the behavioral intervention include both short-term (6-month) improvement in urinary symptoms and long-term (2-year) improvement in anatomic outcomes and prolapse symptoms. This article describes the rationale and design of this randomized trial, focusing on several key design features of potential interest to researchers in the field of female pelvic floor disorders and others conducting randomized surgical trials.

Contemporary Clinical Trials, 2012

This trial compares the change in urgency urinary incontinence episodes over 6 months, tolerabili... more This trial compares the change in urgency urinary incontinence episodes over 6 months, tolerability and cost effectiveness between women receiving daily anticholinergic therapy plus a single intra-detrusor injection of saline versus a single intra-detrusor injection of 100 unit of botulinum toxin A plus daily oral placebo tablets. We present the rationale and design of a randomized controlled trial, Anticholinergic versus Botulinum Toxin, Comparison Trial for the Treatment of Bothersome Urge Urinary Incontinence: ABC Trial, conducted by the NICHD-funded Pelvic Floor Disorders Network. We discuss the innovative nature of this trial and the challenges related to choice of patient population, maintaining masking, cost-effectiveness, ethical considerations, measuring adherence, and placebo development and testing. Enrollment began in April, 2010. 242 participants will be randomized and primary outcome data analysis is anticipated to begin in mid 2012. Several challenges in the trial design are discussed. Randomization to placebo intradetrusor injections may limit recruitment, potentially impacting generalizability. Other challenges included the heavy marketing of drugs for overactive bladder which could impact recruitment of drug naïve women. In addition, anticholinergic medications often cause dry mouth, making masking difficult. Finally, adverse reporting of transient urinary retention is challenging as there is no standardized definition; yet this is the most common adverse event following intradetrusor botulinum toxin injection. The ABC trial will help women with urgency urinary incontinence balance efficacy, side effects and cost of anticholinergic medication versus botulinum toxin intradetrusor injection. The results have the potential to fundamentally change the therapeutic approach to this condition.

American Journal of Obstetrics and Gynecology, 2010

Objectives-This analysis compared 3 continuous variables as summary support loss scores with POPQ... more Objectives-This analysis compared 3 continuous variables as summary support loss scores with POPQ ordinal stages.

American Journal of Obstetrics and Gynecology, 2008

Objectives-To identify risks for mesh/suture erosions following sacrocolpopexy (ASC).

Obstetrics & Gynecology, 2010