Development and validation of the Value of Uterus (VALUS) instrument for women undergoing pelvic organ prolapse surgery: Currently, there are no validated instruments to quantify a woman’s valuation of her uterus. Thanks to the generous support of the FFHA grant, the VALUS instrument was developed as a 9-question instrument to measure the value placed on uterine preservation. This instrument was validated, and found to have high sensitivity and specificity for predicting whether a patient undergoes a uterine-preserving surgery. VALUS is the first instrument that can be used to measure uterine preferences. It can be used as a tool for shared medical-decision making both by patients and their surgeons.
Chang OH, Walters M, Yao M, Lapin B. Development and validation of the Value of Uterus (VALUS) instrument for women undergoing pelvic organ prolapse surgery. Special issue of American Journal of Obstetrics and Gynecology for Society of Gynecologic Surgeons 2021. Submitted for publication.
Histological Study to Assess the CO2 Laser Therapy for the Treatment of Vaginal Atrophy
Principal Investigator: Mickey Karram. In preparation.
Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy for vaginal dryness/vaginal atrophy (VELVET Trial): The purpose of this multi-center clinical trial is to compare the efficacy and safety of CO2 fractional vaginal laser treatment to the current standard treatment, vaginal estrogen therapy, for the treatment of vulvovaginal atrophy (i.e. vaginal dryness and inflammation associated with menopause). This study is actively enrolling new study participants. Participating sites include the Cleveland Clinic, Cleveland OH, Washington Hospital Center, Washington DC, Christ Hospital, Cincinnati OH, Rhode Island Women’s and Infants Hospital, Providence, RI, Standford University, Standford CA, and Wake Forest Baptist Hospital, Winston Salem, NC.
Paraiso MFR, Ferrando CA, Sokol ER, Rardin CR, Matthews CA, Karram MM, Iglesia CB. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: The VeLVET Trial. Menopause. 2020 Jan;27(1):50-56. doi: 10.1097/GME.0000000000001416. PMID: 31574047 Clinical Trial.
Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study (The VAULT Study): The purpose of this multi-center parallel cohort study was to compare the safety and efficacy of two surgical procedures for uterine prolapse: the laparoscopic sacral hysteropexy and the vaginal mesh hysteropexy. 153 women age 35-80 with uterine prolapse were enrolled from one of 8 clinical sites and received one of these two surgical procedures. Overall, both laparoscopic sacral hysteropexy and vaginal mesh hysteropexy resulted in similar outcomes 1 year after surgery with high rates of satisfaction. This study was awarded Best Surgical Paper at the 2015 annual meeting of the American Urogynecologic Society, Seattle, WA, Oct. 13-17, 2015.1.
Gutman RE, Rardin CR, Sokol ER, Matthews C, Park AJ, Iglesia CB, Geoffrion R, Sokol AI, Karram M, Cundiff GW, Blomquist JL, Barber MD.
Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study. Am J Obstet Gynecol. 2017 Jan;216(1):38.e1-38.e11. doi: 10.1016/j.ajog.2016.08.035. Epub 2016 Sep 3. PMID: 27596620.
A blinded multi-center randomized trial comparing TVT-SECUR “U” to the tension-free vaginal tape (TVT) for the surgical treatment of stress urinary incontinence (The SECURITY Trial): This multi-center clinical trial compared the retropubic midurethral sling (tension-free vaginal tape, TVT) to a single-incision mini-sling (TVT SECUR) for the treatment of female stress urinary incontinence. The mini-sling resulted in similar subjective cure rates to the TVT 1 year after surgery but in those women who were not cured, incontinence severity was greater after the mini-sling. This study was awarded the Best Clinical/Surgical Paper at the 2011 American Urogynecology Society Meeting and the 2011 International Urogynecologic Association Axel Ingelman-Sundberg Award for Best Abstract.
Evaluation and Management of Vaginal Mesh Complications: This grant supported a multi-center retrospective cohort study of 347 women presenting to a tertiary care urogynecology practice for evaluation and management of complications after vaginal mesh surgery for pelvic organ prolapse and stress urinary incontinence. Two hundred and sixty women in this study also completed a follow-up survey to evaluate their outcomes after medical or surgical management of their mesh complications. This grant resulted in the publication of two research papers:
Unger CA, Abbott S, Evans JM, Jallad K, Mishra K, Karram MM, Iglesia CB, Rardin CR, Barber MD. Outcomes following treatment for pelvic floor mesh complications. Int Urogynecol J. 2014 Jun;25(6):745-9. doi: 10.1007/s00192-013-2282-9. Epub 2013 Dec 7. PMID:24318564.
Abbott S, Unger CA, Evans JM, Jallad K, Mishra K, Karram MM, Iglesia CB, Rardin CR, Barber MD. Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study. Am J Obstet Gynecol. 2014 Feb;210(2):163.e1-8. doi: 10.1016/j.ajog.2013.10.012. Epub 2013 Oct 11. PMID:24126300.
Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial: To compare the safety and efficacy of the transobturator tape to tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence in patients with and without concurrent pelvic organ prolapse.
Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2008 Mar;111(3):611-21. doi: 10.1097/AOG.0b013e318162f22e. PMID: 18310363.
Medical Student Research Fellowship
FFHA provided a grant to support a year of research study for a student in the Cleveland Clinic Lerner College of Medicine of Case Western University graduating class of 2012. This grant supported Sara Abbott MD’s medical school clinical research thesis titled “A Model to Predict Failure of Uterine Artery Embolization.” In this project advanced statistical modeling were used to develop a nomogram that physicians can use to predict treatment failure and success for an individual patient considering uterine fibroid embolization for symptomatic fibroids. This project also served as her thesis for a Masters of Science in Clinical Research.