Female Urogenital Diseases and Pregnancy Complications Commons^™

Atypical Presentation Of Obstructed Hemivagina And Ipsilateral Renal Anomaly, Christopher Grant, Christopher E. Bayne, N. Kern, Craig A. Peters

Urology Faculty Publications

Herlyn-Werner-Wunderlich Syndrome, otherwise known as obstructed hemivagina and ipsilateral renal anomaly (OHVIRA), is a rare Müllerian anomalyconsisting of uterine didelphys, hemivaginal septum, and ipsilateral renal agenesis. Patients often present at the onset of menarche with abdominal pain and a pelvic mass from an obstructed hemivagina. We report a child who presented with a febrile urinary tract infection and upon further workup was found to have OHVIRA.

The Rejoice Trial: A Phase 3 Randomized, Controlled Trial Evaluating The Safety And Efficacy Of A Novel Vaginal Estradiol Soft-Gel Capsule For Symptomatic Vulvar And Vaginal Atrophy., Ginger D Constantine, James A Simon, James H Pickar, David F Archer, Harvey Kushner, Brian Bernick, Gina Gasper, Shelli Graham, Sebastian Mirkin

Obstetrics and Gynecology Faculty Publications

OBJECTIVE: To evaluate the safety and efficacy of TX-004HR vaginal estradiol soft-gel capsules for moderate-to-severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy.

METHODS: In this randomized, double-blind, placebo-controlled, phase 3 study, postmenopausal women with a self-identified most bothersome symptom of dyspareunia received 4, 10, or 25 μg TX-004HR or placebo for 12 weeks. Four co-primary efficacy endpoints were change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH, and severity of dyspareunia. Secondary endpoints included severity of vaginal dryness and vulvar and/or vaginal itching or irritation. Endometrial histology and adverse events (AEs) were included …

Ureterovaginal Fistula Secondary To Retained Vaginal Foreign Body In A Young Girl, Anjum Bandarkar, Adebunmi O. Adeyiga, Eglal Shalaby-Rana

Radiology Faculty Publications

We present the case of a 13-year-old girl with a recurrent urinary tract infection, malodorous vaginal discharge, and urinary incontinence caused by a retained vaginal foreign body. The foreign body, an aerosol cap retained for over 2 years, resulted in the formation of a ureterovaginal fistula, an extremely rare complication. The critical value of ultrasound and magnetic resonance urography in delineating the foreign body, the fistulous tract, and the intraperitoneal urine leak is described. Through this unique diagnostic dilemma, we wish to highlight that the evaluation of persistent unusual urinary symptoms and vaginal discharge in a young girl must include …

Tx-004hr Vaginal Estradiol Has Negligible To Very Low Systemic Absorption Of Estradiol., David F Archer, Ginger D Constantine, James A Simon, Harvey Kushner, Philip Mayer, Brian Bernick, Shelli Graham, Sebastian Mirkin, Rejoice Study Group.

Obstetrics and Gynecology Faculty Publications

OBJECTIVE: To evaluate the pharmacokinetics of TX-004HR vaginal estradiol softgel capsules when used for treating moderate-to-severe dyspareunia in postmenopausal women with vulvar and vaginal atrophy.

METHODS: A substudy of the REJOICE trial (multicenter, double-blind, placebo-controlled, phase 3) evaluated the pharmacokinetics of 4, 10, and 25-μg TX-004HR doses once/d for 2 weeks, followed by twice/wk for 10 weeks. Serum samples obtained at 2, 4, 6, 10, and 24 hours postdose on days 1 and 14, and once on day 84, were analyzed for area under the serum concentration-time curve, tmax, Cmin, Cavg, and Cmax for estradiol, estrone, and estrone conjugates.

RESULTS: …

Targeted Single Molecule Sequencing Methodology For Ovarian Hyperstimulation Syndrome., Funda Orkunoglu-Suer, Arthur F. Harralson, David Frankfurter, Paul Gindoff, Travis J. O'Brien

Genomics and Precision Medicine Faculty Publications

BACKGROUND: One of the most significant issues surrounding next generation sequencing is the cost and the difficulty assembling short read lengths. Targeted capture enrichment of longer fragments using single molecule sequencing (SMS) is expected to improve both sequence assembly and base-call accuracy but, at present, there are very few examples of successful application of these technologic advances in translational research and clinical testing. We developed a targeted single molecule sequencing (T-SMS) panel for genes implicated in ovarian response to controlled ovarian hyperstimulation (COH) for infertility.

RESULTS: Target enrichment was carried out using droplet-base multiplex polymerase chain reaction (PCR) technology (RainDance®) …