Our fellowship trained and board-certified urogynecologic surgeons, fellows, nurse practitioner, and research nurse coordinator are evaluating methods to restore quality-of-life for women suffering from pelvic floor disorders.

Topics of interest to our researchers include:

  • Urinary incontinence (bladder control problems)
  • Overactive bladder
  • Pelvic organ prolapse (dropped bladder, fallen uterus or vagina, rectal bulging)
  • Accidental bowel leakage
  • Menopausal conditions.

Our specialists use the latest techniques, including minimally invasive vaginal, robotic and laparoscopic surgery. At MedStar Washington Hospital Center, urogynecological surgery is conducted through our Center of Excellence, the National Center for Advanced Pelvic Surgery (NCAPS).

MedStar Washington Hospital Center is currently recruiting participants for two U.S. Food and Drug Administration (FDA) 522 studies. These studies are intended to address questions raised by the FDA concerning complications related to the use of vaginal mesh devices for the treatment of pelvic organ prolapse.


A Study of Uphold LITE vs. Native Tissue for the Treatment of Women with Anterior/Apical Pelvic Organ Prolapse

The purpose of this study is to compare treatment success rates, including quality of life measures, for the Uphold LITE Prolapse Repair System with those of participants receiving native tissue repair. The rate of SAE’s in participants receiving this mesh device also will be compared with those of participants receiving native tissue repair. 

MedStar Washington Hospital Center researchers also are conducting the following trials:


Efficacy, Safety, and Tolerability of Mirabegron in Older Adults with Overactive Bladder (PILLAR)

The primary objectives of this clinical trial are to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adults with overactive bladder.
Principal investigator: Andrew Sokol, MD.
https://clinicaltrials.gov/ct2/show/study/NCT02216214?show_locs=Y#locn


Development of a Patient-Centered Pelvic Floor Complication Scale

The primary aim of this study is to create a simplified, patient-centered scale that will allow investigators to calculate the severity of complications associated with pelvic reconstructive surgery and that will reflect the views of patients and physicians. The investigators will seek patient responses across diverse racial, ethnic, and socioeconomic groups regarding knowledge, perceptions, concerns, and fears about complications related to surgery in general and to pelvic reconstructive surgery in particular.
Principal investigator: Robert Gutman, MD.


Effect of Vaginal Estrogen on Asymptomatic Microhematuria (EVER)

This study is designed to determine whether vaginal estrogen use is associated with resolution of asymptomatic microhematuria in postmenopausal women.
Principal investigators: Cheryl B. Iglesia, MD; Lee A. Richter, MD.
August 2014 – present
https://clinicaltrials.gov/ct2/show/NCT02213757?term=EVER&rank=4


Restorelle 522 Study

Restorelle® Transvaginal Mesh versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse 522 Study

The Restorelle 522 study aims to evaluate the effectiveness of the Restorelle transvaginal mesh repair as compared to native tissue repair in women who have surgery done for anterior/apical or posterior/apical pelvic organ prolapse. Women enrolled will undergo baseline testing and questionnaires prior to the surgery of their choice as well as follow up at 2, 6,12,18, 24 and 36 months.

To participate in the study, you must report a bothersome bulge you are able to see or feel, have pelvic organ prolapse with the leading edge at or beyond the level of the hymen, and be available for follow up at designated study time points.


Velvet

A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause

The Velvet trial is a multi-centered, randomized prospective single-blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream therapy for the treatment of vulvovaginal atrophy, also known as genitourinary syndrome of menopause. Subjects are randomized to receive treatment with either the laser or estrogen for 3 months with follow up at 3 and 6 months and the option to cross over intervention groups after 6 months.

To participate in the study, you must be menopausal with no menstruation in the last 12 months, complain of vaginal atrophy symptoms and demonstrate pelvic organ prolapse on exam without having had pelvic surgery in the last 6 months.


CuRLS

A randomized trial of Clobetasol Proprionate Versus Radiofrequency CO2 laser for the treatment of Lichen Sclerosus

The CuRLS trial is a randomized, prospective single-blinded trial designed to determine whether the CO2 laser is an effective treatment for lichen sclerosis as compared to steroid cream, which is the current standard of care. Study participants are randomly assigned to treatment with either the laser or the steroid cream for 3 months with follow up appointments at 6.

To participate in this trial, you must have biopsy-proven symptomatic vulvar lichen sclerosus and availability to follow up 6 months after the first treatment.


TROOP

Treatment of Refractory Overactive Bladder with Onabotulinum toxin A vs. PTNS

The TROOP trial is designed for patients with overactive bladder that has been unresponsive to 2 prior treatments to determine whether satisfaction and quality of life conditions are most improved by Onabotulinum toxin A (BoNTA; bladder botox) or percutaneus tibial nerve stimulation (PTNS). Women in this study will undergo baseline evaluation and questionnaires before receiving their choice of either BoNTA or PTNS with follow up questionnaires at 3 and 12 months.

To participate in this trial, you must have overactive bladder that has failed 2 prior treatments, exhibit urinary urgency with or without incontinence, and be available for follow up at 1 year after enrollment in the study.


Pelvic Floor Disorders Registry-Quality and Research (PFDR-QR): National Patient Registry for Treatment of Pelvic Floor Disorders

PFDR-QR is a national registry for providers who care for patients with pelvic floor disorders, such as urinary incontinence and pelvic organ prolapse. The American Urogynecologic Society (AUGS) is an organization that represents health care providers who treat women with pelvic organ prolapse. AUGS has developed the PFDR Registry to collect specific information on patients undergoing treatment for pelvic organ prolapse. The information collected will provide information about the effectiveness and safety associated with various surgical and nonsurgical treatments. The Registry’s goal is to enroll as many patients as possible who are having treatment for prolapse in order to gather information about prolapse treatment outcomes. Enrollment is ongoing and will continue until the registry is closed. It is anticipated that 10,000 women or more across North America will be enrolled into the registry over the upcoming years.