Obstetrics and Gynecology Commons^™

Characteristics And Outcomes Of Patients With Pregnancy-Related End-Stage Kidney Disease., Lauren Kucirka, Ana Angarita, Tracy Manuck, Kim Boggess, Vimal Derebail, Mollie Wood, Michelle Meyer, Dorry Segev, Monica Reynolds

Department of Obstetrics and Gynecology Faculty Papers

IMPORTANCE: The incidence of pregnancy-related acute kidney injury is increasing and is associated with significant maternal morbidity including progression to end-stage kidney disease (ESKD). Little is known about characteristics and long-term outcomes of patients who develop pregnancy-related ESKD.

OBJECTIVES: To examine the characteristics and clinical outcomes of patients with pregnancy-related ESKD and to investigate associations between pre-ESKD nephrology care and outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This was a cohort study of 183 640 reproductive-aged women with incident ESKD between January 1, 2000, and November 20, 2020, from the US Renal Data System and maternal data from births captured in the …

Impact Of Homologous Recombination Status And Responses With Veliparib Combined With First-Line Chemotherapy In Ovarian Cancer In The Phase 3 Velia/Gog-3005 Study, Elizabeth M Swisher, Carol Aghajanian, David M O'Malley, Gini F Fleming, Scott H Kaufmann, Douglas A Levine, Michael J Birrer, Kathleen N Moore, Nick M Spirtos, Mark S Shahin, Thomas J Reid, Michael Friedlander, Karina Dahl Steffensen, Aikou Okamoto, Vasudha Sehgal, Peter J Ansell, Minh H Dinh, Michael A Bookman, Robert L Coleman

Kimmel Cancer Center Faculty Papers

Objective: In the Phase 3 VELIA trial (NCT02470585), PARP inhibitor (PARPi) veliparib was combined with first-line chemotherapy and continued as maintenance for patients with ovarian carcinoma enrolled regardless of chemotherapy response or biomarker status. Here, we report exploratory analyses of the impact of homologous recombination deficient (HRD) or proficient (HRP) status on progression-free survival (PFS) and objective response rates during chemotherapy.

Methods: Women with Stage III-IV ovarian carcinoma were randomized to veliparib-throughout, veliparib-combination-only, or placebo. Stratification factors included timing of surgery and germline BRCA mutation status. HRD status was dichotomized at genomic instability score 33. During combination therapy, …

Ovarian Cancer Epidemiology, Healthcare Access And Disparities (Orchid): Methodology For A Population-Based Study Of Black, Hispanic And White Patients With Ovarian Cancer, Tomi Akinyemiju, April Deveaux, Lauren Wilson, Anjali Gupta, Ashwini Joshi, Malcolm Bevel, Chioma Omeogu, Onyinye Ohamadike, Bin Huang, Maria Pisu, Margaret Liang, Molly Mcfatrich, Erin Daniell, Laura Jane Fish, Kevin Ward, Maria Schymura, Andrew Berchuck, Arnold L. Potosky

Biostatistics Faculty Publications

INTRODUCTION: Less than 40% of patients with ovarian cancer (OC) in the USA receive stage-appropriate guideline-adherent surgery and chemotherapy. Black patients with cancer report greater depression, pain and fatigue than white patients. Lack of access to healthcare likely contributes to low treatment rates and racial differences in outcomes. The Ovarian Cancer Epidemiology, Healthcare Access and Disparities study aims to characterise healthcare access (HCA) across five specific dimensions-Availability, Affordability, Accessibility, Accommodation and Acceptability-among black, Hispanic and white patients with OC, evaluate the impact of HCA on quality of treatment, supportive care and survival, and explore biological mechanisms that may contribute to …

Tx-004hr Improves Sexual Function As Measured By The Female Sexual Function Index In Postmenopausal Women With Vulvar And Vaginal Atrophy: The Rejoice Trial., Sheryl A Kingsberg, Leonard Derogatis, James A Simon, Ginger D Constantine, Shelli Graham, Brian Bernick, Gina Gasper, Sebastian Mirkin

Obstetrics and Gynecology Faculty Publications

INTRODUCTION: TX-004HR is an investigational, applicator-free, vaginal soft gel capsule containing low-dose solubilized 17β-estradiol. The phase 3, randomized, double-blinded, placebo-controlled, multicenter REJOICE trial has shown TX-004HR to be safe and effective for the treatment of moderate to severe dyspareunia in postmenopausal women with vulvar and vaginal atrophy (VVA).

AIM: To evaluate the effect of TX-004HR on female sexual dysfunction in postmenopausal women with VVA.

METHODS: The REJOICE study compared the effects of 12-week treatment with TX-004HR (4, 10, or 25 μg) with placebo in postmenopausal women (40-75 years old) with VVA and a most bothersome symptom of moderate to severe …

Psychological Empowerment And Job Satisfaction Between Baby Boomer And Generation X Nurses, Amy Sparks

Amy E.T. Sparks

AIM: This paper is a report of a study of differences in nurses' generational psychological empowerment and job satisfaction. BACKGROUND: Generations differ in work styles such as autonomy, work ethics, involvement, views on leadership, and primary views on what constitutes innovation, quality, and service. METHOD: A secondary analysis was conducted from two data sets resulting in a sample of 451 registered nurses employed at five hospitals in West Virginia. One data set was gathered from a convenience sample and one from a randomly selected sample. Data were collected from 2000 to 2004. RESULTS: Baby Boomer nurses reported higher mean total …

The Effect Of Age On The Expression Of Apoptosis Biomarkers In Human Spermatozoa, A. Colin, G. Barroso, N. Gomez-Lopez, Eyup Duran, S. Oehninger

Eyup Hakan Duran

OBJECTIVE: To evaluate the impact of age on the expression of apoptotic biomarkers in human spermatozoa. DESIGN: Cross sectional, prospective study. SETTING: Academic centers. PATIENT(S): Healthy volunteers with proven fertility, stratified by age (n = 25, range: 20-68 years). INTERVENTION(S): Examination of serum hormone levels and basic semen parameters, and assessment of early (plasma membrane translocation of phosphatidylserine) and late (DNA fragmentation) sperm apoptotic markers by flow cytometry (using Annexin-V binding and terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling). MAIN OUTCOME MEASURE(S): Apoptosis markers. RESULT(S): Advancing male age was significantly and positively correlated with Annexin-V binding results. Although not significant, …

Extragenital Malignant Mixed Mesodermal Tumor: Case Report And Review Of The Literature, M. Ergeneli, B. Demirhan, Eyup Duran, M. Erdogan

Eyup Hakan Duran

Malignant mixed mesodermal tumors rarely occur in extragenital sites. An 80-year-old patient presented with a malignant mixed mesodermal tumor, consisting of papillary serous adenocarcinoma and chondrosarcomatous components. The patient refused further treatment following surgery and died of disease 2.5 months later. Based on the present case and a review of the literature, primary extragenital malignant mixed mesodermal tumors prove to be rare but highly malignant neoplasms. Further data is yet to be gathered in order to determine the exact origin and behavior of these tumors.

Incidence Of Anti-Heparin/Platelet Factor 4 Antibodies And Heparin-Induced Thrombocytopenia In Medical Patients [Turkish], M. Demir, E. Tekgündüz, M. Edis, Eyup Duran, T. Kürüm

Eyup Hakan Duran

OBJECTIVE: Heparin-induced thrombocytopenia (HIT) is a life threatening complication of heparin therapy, causing thrombosis. The aim of our study was to find out the frequencies of HIT antibody seroconversion and clinical HIT in Turkish medical patients on different forms of heparins. METHODS: Our study included 61 patients who were on unfractionated heparin (UFH) (n: 37) and low molecular weight heparin (LMWH) (n: 24) therapies. The frequency of HIT antibody formation was determined by means of antigenic (ELISA), and functional assays (serotonin release assay-SRA). RESULTS: The seroconversion rates in UFH and LMWH groups were found to be 18.9% and 4.1% (ELISA), …

Pelvic Floor Symptoms And Lifestyle Factors In Older Women, Catherine Bradley, Colleen Kennedy, I. Nygaard

Colleen Kennedy Stockdale

OBJECTIVES: To measure the prevalence of pelvic floor symptoms in noncare-seeking older women and the association between symptoms and lifestyle factors. METHODS: Women enrolled at one site of the Women's Health Initiative Hormone Therapy clinical trial completed a questionnaire, modified from the Pelvic Floor Distress Inventory, on bladder, bowel, and prolapse symptoms. Individual symptoms and symptom groups were examined in a cross-sectional analysis. RESULTS: In the 297 women who participated, mean age was 68.2 years, mean body mass index (BMI) was 30.2 kg/m(2), and median vaginal parity was 3. The median number of symptoms endorsed was 3 (range 0-18). The …

Bladder And Bowel Symptoms Among Women With Vulvar Disease: Are They Universal?, Colleen Kennedy, I. Nygaard, Catherine Bradley, R. Galask

Colleen Kennedy Stockdale

OBJECTIVE: To compare the prevalence of painful bladder syndrome, recurrent urinary tract infections, urinary leakage and irritable bowel syndrome between women with specific vulvar disorders and controls. STUDY DESIGN: Women with a primary diagnosis of vulvar intraepithelial neoplasia (dysplasia), vulvar vestibulitis (vestibulitis), contact vulvitis, atrophic vulvovaginitis, lichen simplex, lichen sclerosus and lichen planus, were compared to women presenting for annual examinations. RESULTS: As compared to controls, painful bladder syndrome was more prevalent among subjects with dysplasia, vestibulitis and contact vulvitis; a history of recurrent urinary tract infection was more prevalent among subjects with contact vulvitis; and urinary incontinence was less …

Risk Factors For Painful Bladder Syndrome In Women Seeking Gynecologic Care, Colleen Kennedy, Catherine Bradley, R. Galask, I. Nygaard

Colleen Kennedy Stockdale

The aim of this cross-sectional study was to report risk factors for painful bladder syndrome in women. We surveyed 645 women presenting for care to general gynecology clinics and a vulvar specialty clinic using a standardized questionnaire and validated outcome measures. We used two definitions for painful bladder syndrome, based on the O'Leary-Sant interstitial cystitis symptom and problem indices. Of those women surveyed, 29.5% met broader criteria and 8.5% met more restrictive criteria for painful bladder syndrome. After adjusting for confounders, bladder pain was significantly associated with current smoking, irritable bowel syndrome, and a generalized pain disorder. Tobacco use, the …

Vulvar Carcinoma With Hypercalcemia, Jennifer Niebyl, Rene Genadry, E. Friedrich, E. Wilkinson, J. Woodruff

Jennifer R Niebyl

Hypercalcemia associated with nonmetastatic malignancy has been reported most frequently with lung or kidney tumors, while among gynecologic malignancies, the ovary has been the most common primary site. The pertinent clinicopathologic features of 2 cases of nonmetastatic vulvar carcinoma producing hypercalcemia are described in the present report. Including 3 previously reported cases, the vulva is seen to be the second most common site in the female genital tract for production of this paraendocrine syndrome. The clinician should be aware of the association of hypercalcemia and mental confusion with bulky vulvar tumors, so that surgery will not needlessly be delayed in …

Social Support, Psychological Distress, And Natural Killer Cell Activity In Ovarian Cancer, S. Lutgendorf, A. Sood, B. Anderson, S. Mcginn, H. Maiseri, M. Dao, J. Sorosky, Koen De Geest, J. Ritchie, D. Lubaroff

Koen De Geest

PURPOSE: Psychosocial stress has been related to impaired immunity in cancer patients. However, the extent to which these relationships exist in immune cells in the tumor microenvironment in humans has not been explored. We examined relationships among distress, social support, and natural killer (NK) cell activity in ovarian cancer patients in peripheral-blood mononuclear cells (PBMC), ascitic fluid, and tumor-infiltrating lymphocytes (TIL). PATIENTS AND METHODS: Patients awaiting surgery for a pelvic mass suspected of being ovarian cancer completed psychological questionnaires and gave a presurgical sample of peripheral blood. Samples of tumor and ascites were taken during surgery, lymphocytes were then isolated, …

Phase Ii Clinical Trial Of Ixabepilone In Patients With Recurrent Or Persistent Platinum- And Taxane-Resistant Ovarian Or Primary Peritoneal Cancer: A Gynecologic Oncology Group Study, Koen De Geest, John Blessing, Robert Morris, S. Diane Yamada, Bradley Monk, Susan Zweizig, Daniela Matei, Carolyn Muller, William Richards

Koen De Geest

PURPOSE Ixabepilone (BMS-247550) is a microtubule-stabilizing epothilone B analog with activity in taxane-resistant metastatic breast cancer. The Gynecologic Oncology Group conducted a phase II evaluation of the efficacy and safety of ixabepilone in patients with recurrent or persistent platinum- and taxane-resistant primary ovarian or peritoneal carcinoma. PATIENTS AND METHODS Patients with measurable platinum- and taxane-resistant ovarian or peritoneal carcinoma, defined as progression during or within 6 months of one prior course of treatment with each agent, received intravenous ixabepilone 20 mg/m(2) administered over 1 hour on days 1, 8, and 15 of a 28-day cycle. RESULTS Of 51 patients entered, …

Preservation Of Immune Function In Cervical Cancer Patients During Chemoradiation Using A Novel Integrative Approach., Susan Lutgendorf, Elizabeth Mullen-Houser, Daniel Russell, Koen De Geest, Geraldine Jacobson, Laura Hart, David Bender, Barrie Anderson, Thomas Buekers, Michael Goodheart, Michael Antoni, Anil Sood, David Lubaroff

Koen De Geest

Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side-effects, and immunosuppression. This prospective randomized clinical trial examined effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation. Sixty women with stages IB1 to IVA cervical cancer were randomly assigned to receive UC or 4 ×/weekly individual sessions of either HT or RT immediately following radiation during their 6-week chemoradiation treatment. Patients completed psychosocial …

Diurnal Cortisol Dysregulation, Functional Disability, And Depression In Women With Ovarian Cancer., Aliza Weinrib, Sandra Sephton, Koen De Geest, Frank Penedo, David Bender, Bridget Zimmerman, Clemens Kirschbaum, Anil Sood, David Lubaroff, Susan Lutgendorf

Koen De Geest

BACKGROUND: Multiple alterations in circadian rhythms have been observed in cancer patients, including the diurnal rhythm of the adrenal hormone cortisol. Diurnal cortisol alterations have been associated with cancer-related physiological processes as well as psychological stress. Here we investigate alterations in diurnal cortisol rhythm in ovarian cancer patients, and potential links with depression, life stress, and functional disability.

METHODS: Women (n = 177) with suspected ovarian cancer completed questionnaires and collected salivary cortisol 3× daily for 3 consecutive days before surgery. One hundred women were subsequently diagnosed with ovarian cancer and 77 with benign disease. In addition, healthy women (n …

A Single-Institution Evaluation Of Factors Important In Fallopian Tube Carcinoma Recurrence And Survival., Alireza Shamshirsaz, Thomas Buekers, Koen De Geest, David Bender, Gideon Zamba, Michael Goodheart

Koen De Geest

OBJECTIVE: The aim of this study was to identify prognostic factors and markers that influence clinical outcomes in patients with primary fallopian tube carcinoma at a single tertiary health care center. These prognostic factors may be of clinical importance and can subsequently be included in future clinical trials. MATERIALS AND METHODS: A retrospective review of our Tumor Registry and Gynecologic Oncology database was conducted to include any patients with a diagnosis of fallopian tube carcinoma between the years 1994 and 2005. We identified clinicopathological data to evaluate factors important in recurrence, disease-specific and overall survival. Kaplan-Meier curves were generated, and …

Sleep Disturbance, Cytokines, And Fatigue In Women With Ovarian Cancer., Lauren Clevenger, Andrew Schrepf, Desire Christensen, Koen De Geest, David Bender, Amina Ahmed, Michael Goodheart, Frank Penedo, David Lubaroff, Anil Sood, Susan Lutgendorf

Koen De Geest

Pro-inflammatory cytokines, such as interleukin-6 (IL-6), have been implicated in the underlying processes contributing to sleep regulation and fatigue. Despite evidence for sleep difficulties, fatigue, and elevations in IL-6 among women with ovarian cancer, the association between these symptoms and IL-6 has not been investigated. To address this knowledge gap, we examined relationships between sleep disturbance, fatigue, and plasma IL-6 in 136 women with ovarian cancer prior to surgery. These relationships were also examined in 63 of these women who were disease-free and not receiving chemotherapy one year post-diagnosis. At both time-points, higher levels of IL-6 were significantly associated with …

Social Isolation Is Associated With Elevated Tumor Norepinephrine In Ovarian Carcinoma Patients., Susan Lutgendorf, Koen De Geest, Laila Dahmoush, Donna Farley, Frank Penedo, David Bender, Michael Goodheart, Thomas Buekers, Luis Mendez, Gina Krueger, Lauren Clevenger, David Lubaroff, Anil Sood, Steve Cole

Koen De Geest

Noradrenergic pathways have been implicated in growth and progression of ovarian cancer. Intratumoral norepinephrine (NE) has been shown to increase with stress in an animal cancer model, but little is known regarding how tumor NE varies with disease stage and with biobehavioral factors in ovarian cancer patients. This study examined relationships between pre-surgical measures of social support, depressed mood, perceived stress, anxiety, tumor histology and tumor catecholamine (NE and epinephrine [E]) levels among 68 ovarian cancer patients. We also examined whether associations observed between biobehavioral measures and tumor catecholamines extended to other compartments. Higher NE levels were found in advanced …

A Phase Ii Study Of Docetaxel In Paclitaxel-Resistant Ovarian And Peritoneal Carcinoma: A Gynecologic Oncology Group Study, Peter Rose, John Blessing, Harrison Ball, James Hoffman, David Warshal, Koen Degeest, David Moore

Koen De Geest

OBJECTIVES: Docetaxel is an inhibitor of microtubule depolymerization and has demonstrated activity in paclitaxel-resistant breast cancer and gynecologic cancer. The Gynecologic Oncology Group (GOG) conducted a study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma to determine its activity, and nature and degree of toxicity, in this cohort of patients.

METHODS: Patients with platinum- and paclitaxel-resistant ovarian or peritoneal carcinoma, defined as progression while on or within 6 months of therapy, were eligible if they had measurable disease and had not received more than one chemotherapy regimen. Docetaxel at a dose of 100 mg/m(2) was administered iv over 1 h …

Postoperative Irradiation In Malignant Tumors Of Submandibular Gland, Donghai Dai

Donghai Dai

A retrospective review of 18 patients with treated primary malignant tumors of submandibular gland is presented. The data revealed that initial control of malignancies was inversely related to the presence of disease and surgical margins. Postoperative radiation therapy was used in cases with positive surgical margins. Of the patients with inadequate surgical margins, 71% achieved local relapse when they had surgery alone, compared with 27% of the group that received postoperative irradiation. This study suggests that adjuvant radiation therapy may improve the local control and survival. Such therapy can serve as the salvage method for those who have inadequate surgical …

Endometrial Adenocarcinoma With Trophoblastic Differentiation., Catherine Bradley, I. Benjamin, J. Wheeler, S. Rubin

Catherine S. Bradley

OBJECTIVE: To report a case of stage IIIc poorly differentiated endometrial adenocarcinoma with trophoblastic differentiation and to review previously reported cases. METHODS: The clinical course and histopathology of the case were reviewed, and a literature search for other reported cases was performed. RESULTS: The tumor contained syncytiotrophoblast-like giant cells that stained positively for the beta subunit of human chorionic gonadotropin (beta-hCG), and the patient's serum beta-hCG level was elevated (95 mIU/ml), but became undetectable after treatment. Beta-hCG was used as a tumor marker during further therapy. At 16 months' survival, she remains without evidence of disease and with a beta-hCG …

Pelvic Organ Prolapse In Older Women: Prevalence And Risk Factors., Ingrid Nygaard, Catherine Bradley, Debra Brandt

Catherine S. Bradley

OBJECTIVE: We sought to estimate the prevalence of pelvic organ prolapse in older women using the Pelvic Organ Prolapse Quantification examination and to identify factors associated with prolapse. METHODS: Women with a uterus enrolled at one site of the Women's Health Initiative Hormone Replacement Therapy randomized clinical trial were eligible for this ancillary cross-sectional study. Subjects underwent a Pelvic Organ Prolapse Quantification examination during a maximal Valsalva maneuver and in addition completed a questionnaire. Logistic regression was used to identify independent risk factors for each of 2 definitions of prolapse: 1) Pelvic Organ Prolapse Quantification stage II or greater and …

A New Questionnaire For Urinary Incontinence Diagnosis In Women: Development And Testing, Catherine Bradley, E. Rovner, M. Morgan, M. Berlin, J. Novi, J. Shea, L. Arya

Catherine S. Bradley

OBJECTIVE: The purpose of this study was to develop a questionnaire for urinary incontinence diagnosis in women and to test its reliability and validity, with incontinence specialists' clinical evaluations as the gold standard. STUDY DESIGN: One hundred seventeen urogynecology outpatients with urinary incontinence symptoms completed the Questionnaire for Urinary Incontinence Diagnosis at enrollment and 1 week and 9 months later. Baseline clinical diagnoses were compared with Questionnaire for Urinary Incontinence Diagnosis diagnoses (criterion validity). Nine-month Questionnaire for Urinary Incontinence Diagnosis change scores were compared across treatment groups (responsiveness). RESULTS: Clinical diagnoses included stress (n = 15), urge (n = 26), …

Effects Of Colpocleisis On Bowel Symptoms Among Women With Severe Pelvic Organ Prolapse, R. Gutman, Catherine Bradley, W. Ye, A. Markland, W. Whitehead, M. Fitzgerald

Catherine S. Bradley

INTRODUCTION AND HYPOTHESIS: Our objective was to evaluate bowel symptoms after colpocleisis. METHODS: This was a planned ancillary analysis of a prospective, colpocleisis cohort study of 152 women. Those with baseline and 1-year questionnaires (Colorectal-Anal Distress Inventory (CRADI) and the Colorectal-Anal Impact Questionnaire (CRAIQ)) were included. "Bothersome" CRADI symptoms (score>2("moderately", "quite a bit")) were identified. CRADI and CRAIQ scores were compared, and postoperative symptom resolution and new symptom development were measured. RESULTS: Of 121 (80%) subjects with complete data, mean age was 79.2 +/- 5.4 years and all had stage 3-4 prolapse. Procedures performed: partial colpocleisis (61%), total colpocleisis …

Vaginal Wall Descensus And Pelvic Floor Symptoms In Older Women, Catherine Bradley, I. Nygaard

Catherine S. Bradley

OBJECTIVE: To understand the clinical significance of early pelvic organ prolapse in older women, we studied associations between vaginal descensus and pelvic floor symptoms. METHODS: In this cross-sectional study, 270 women enrolled at one site of the Women's Health Initiative clinical trial completed a questionnaire modified from the Pelvic Floor Distress Inventory on pelvic floor symptoms and underwent a Pelvic Organ Prolapse Quantification (POP-Q) examination. We tested associations between symptoms (individual and grouped) with anterior, posterior, uterine, and maximum vaginal descensus. RESULTS: Mean age was 68 years. Ninety-six percent had POP-Q stages I or II. Only obstructive urinary symptoms and …

Urinary Incontinence Self-Report Questions: Reproducibility And Agreement With Bladder Diary, Catherine Bradley, J. Brown, S. Van Den Eeden, M. Schembri, A. Ragins, D. Thom

Catherine S. Bradley

INTRODUCTION AND HYPOTHESIS: This study aims to measure self-report urinary incontinence questions' reproducibility and agreement with bladder diary. METHODS: Data were analyzed from the Reproductive Risk of Incontinence Study at Kaiser. Participating women reporting at least weekly incontinence completed self-report incontinence questions and a 7-day bladder diary. Self-report question reproducibility was assessed and agreement between self-reported and diary-recorded voiding and incontinence frequency was measured. Test characteristics and area under the curve were calculated for self-reported incontinence types using diary as the gold standard. RESULTS: Five hundred ninety-one women were included and 425 completed a diary. The self-report questions had moderate …

Pharmacologic Treatment For Urgency-Predominant Urinary Incontinence In Women Diagnosed Using A Simplified Algorithm: A Randomized Trial, A. Huang, R. Hess, L. Arya, H. Richter, L. Subak, Catherine Bradley, R. Rogers, D. Myers, K. Johnson, W. Gregory, S. Kraus, M. Schembri, J. Brown

Catherine S. Bradley

OBJECTIVE: The purpose of this study was to evaluate clinical outcomes associated with the initiation of treatment for urgency-predominant incontinence in women diagnosed by a simple 3-item questionnaire. STUDY DESIGN: We conducted a multicenter, double-blinded, 12-week randomized trial of pharmacologic therapy for urgency-predominant incontinence in ambulatory women diagnosed by the simple 3-item questionnaire. Participants (N = 645) were assigned randomly to fesoterodine therapy (4-8 mg daily) or placebo. Urinary incontinence was assessed with the use of voiding diaries; postvoid residual volume was measured after treatment. RESULTS: After 12 weeks, women who had been assigned randomly to fesoterodine therapy reported 0.9 …

Bowel Symptoms In Women Planning Surgery For Pelvic Organ Prolapse, Catherine Bradley, M. Brown, G. Cundiff, P. Goode, K. Kenton, I. Nygaard, W. Whitehead, P. Wren, A. Weber

Catherine S. Bradley

OBJECTIVE: The objective of the study was to measure associations between bowel symptoms and prolapse. STUDY DESIGN: Baseline data were analyzed from 322 women in the Colpopexy And Urinary Reduction Efforts trial of sacrocolpopexy with or without Burch colposuspension. Women completed the Colorectal-Anal Distress Inventory and Colorectal-Anal Impact Questionnaire and underwent Pelvic Organ Prolapse Quantification. Associations between symptoms and questionnaire scores and Pelvic Organ Prolapse Quantification measures were assessed. RESULTS: Mean age was 61 +/- 10 years. Pelvic Organ Prolapse Quantification stages were II (14%), III (67%), and IV (19%). Colorectal-Anal Distress Inventory symptoms did not increase with prolapse stage. …

Gastrointestinal Complications Following Abdominal Sacrocolpopexy For Advanced Pelvic Organ Prolapse, W. Whitehead, Catherine Bradley, M. Brown, L. Brubaker, R. Gutman, R. Varner, A. Visco, A. Weber, H. Zyczynski

Catherine S. Bradley

OBJECTIVE: The aims of this secondary analysis of the "Colpopexy And Urinary Reduction Efforts" (CARE) study were to estimate the incidence of postoperative gastrointestinal complications and identify risk factors. STUDY DESIGN: We prospectively identified gastrointestinal complications and serious adverse events (SAE) for 12 months after sacrocolpopexy. Two surgeons independently reviewed reports of ileus or small bowel obstruction (SBO). RESULTS: Eighteen percent of 322 women (average age 61.3 years) reported "nausea, emesis, bloating, or ileus" during hospitalization and 9.8% at 6 weeks. Nineteen women (5.9%; CI 3.8%, 9.1%) had a possible ileus or SBO that generated SAE reports: 4 (1.2%, CI …