A Look Back: Innovations in the Field of Urogynecology

By Marie Fidela Paraiso, MD

Cleveland Clinic has been at the forefront of advances in urogynecology over the past 25 years, most prominently taking the lead in converting open procedures to minimally invasive surgeries. Our team adopted new techniques early on, and has been become well known for studying these techniques in randomized clinical trials. We are also part of the Pelvic Floor Disorders Network, a group of top medical centers in the United States that has received numerous NIH/NICHD grants to perform prospective trials in the management of women’s pelvic floor disorders, which affect at least 10% of women ages 20 to 39 years, increasing with age to at least 50% of women ages > 80 years old.

Mark Walters, MD, who recently retired, was one of our most notable practitioners. Dr. Walters was professor and Vice Chair of Gynecology in the Ob/Gyn & Women’s Health Institute at Cleveland Clinic for many years, and was coeditor of Urogynecology and Reconstructive Pelvic Surgery, the main text for the subspecialty with four editions. Along with Mickey Karram, MD, Dr. Walters is thought of as one of the “fathers of urogynecology.” In addition, Tommaso Falcone, MD, currently Chief of Staff, Chief Medical Officer and Medical Director at Cleveland Clinic London, brought advanced laparoscopic surgeries for pelvic floor disorders to the section during his time with us as Chair of the Ob/Gyn & Women’s Health Institute.

I was recruited for the urogynecology section in 1998 to advance our footprint in minimally invasive surgeries. At that time, we were one of the first sections to be approved for a fellowship in Female Pelvic Medicine and Reconstructive Pelvic Surgery, and we graduated our first fellow in the 2000.

Innovations in urogynecology

Some of our most meaningful accomplishments include the areas of:

• Midurethral slings/vaginal mesh. We were among the first to utilize and investigate midurethral slings to repair stress urinary incontinence, going back as far as 1999, and vaginal mesh for uterovaginal prolapse. When mesh complications began to be reported, we became a referral site for mesh removals due to our expertise in urogynecology procedures. In 2019, the FDA ordered transvaginal mesh implants to be taken off of the U.S. market. However, around that time, working with the Pelvic Floor Disorders Network we published data comparing the efficacy of vaginal mesh hysteropexy with vaginal hysterectomy. The results were published in JAMA, and revealed no significant differences between the two procedures. In a subsequent report with five years of follow-up published in the American Journal of Obstetrics and Gynecology in 2021, we found no differences in patient-reported outcomes with mesh versus hysterectomy; however, mesh hysteropexy had 18%fewer primary outcome failures (retreatment, prolapse beyond the hymen or bulge symptoms) compared to native tissue repair leading us to suggest that the vaginal mesh hysteropexy procedure again be made available to patients.
• Laparoscopic Burch tension-free vaginal tape (TVT) procedure. In a randomized trial I performed with Dr. Walters, Mickey M. Karram, MD, and Matthew D. Barber, MD, MHS, we compared open Burch colposuspension with TVT, finding that TVT resulted in better objective and subjective cure rates for urodynamic stress incontinence. The study was published in Obstetrics & Gynecology in 2004.
• Rectocele. Along with Drs. Barber and Walters and Tristi W. Muir, MD, I published the first rectocele repair trial comparing three surgical techniques, including biologic graft augmentation. We found that posterior colporraphy and site-specific rectocele repair led to similar anatomic and functional outcomes, but the porcine small intestinal submucosa graft was inferior in this study. Based on our study, which was published in 2006 in the American Journal of Obstetrics and Gynecology, the company manufacturing the graft decided not to release the product.
• Robotic sacrocolpopexy and hysterectomy. When robotics came out for gynecologic indications in 2005, I was one of the first urogynecologists in the United States to be approached to pioneer some urogynecologic procedures. In addition, our group won the Roy M. Pitkin Award for outstanding research in Obstetrics & Gynecology in 2011 for a publication comparing laparascopic to robotic sacrocolpopexy for vaginal prolapse. I was the lead author of the paper, and we found that robotic-assisted sacrocolpopexy compared with the conventional laparascopic approach was associated with significantly greater operating time, greater postoperative pain during 6 weeks after surgery, and greater cost — a result that was confirmed in a second prospective trial comparing robotic-assisted laparoscopic hysterectomy and conventional laparoscopic hysterectomy published in Obstetrics & Gynecology in 2013.
• CO2 fractional laser (Mona Lisa Touch). Beginning in 2015, I was an early adopter and investigator of CO2 fractional laser therapy for the vagina and vulva in the United States. Cecile Ferrando, MD, MPH and I, with coauthors from other institutions, were the first to publish a prospective trial comparing laser therapy to treatment with vaginal estrogen, showing that it is non-inferior to vaginal estrogen therapy, which is the gold standard treatment for genitourinary syndrome of menopause. We have since confirmed that laser therapy is an option for women who have contraindications to vaginal estrogen to relieve genitourinary symptoms, especially pain with intercourse.
• Validated questionnaires. Barber, who was formerly Vice Chair for Research in the Ob/Gyn & Women’s Health Institute, is credited with developing many validated questionnaires to study quality of life in women suffering from pelvic floor disorders, specifically urinary, bowel and pelvic organ prolapse symptoms during his time at Cleveland Clinic.

Predictions for future innovations

Stem-cell and platelet-rich plasma therapies are just now emerging as prospective treatments for pelvic floor disorders, and we are beginning to investigate these therapies at Cleveland Clinic. Microbiome and genetic therapies are also on our radar. Genetic therapies will allow us to discern women who are at risk for incontinence and pelvic organ collapse or collagen vascular disorders, and direct preventative measures or treat patients at an early stage of disease.

About the author

Marie Fidela R. Paraiso, MD, is Professor of Obstetrics, Gynecology, and Reproductive Medicine and Vice Chair of Ob/Gyn & Women’s Health Institute at Cleveland Clinic, where she also serves on the Cleveland Clinic Board of Governors. Additionally, Dr. Paraiso holds a joint appointment in the Cleveland Clinic Urological Institute. Her expertise includes laparoscopic and robotic-assisted laparoscopic surgery, urinary and fecal incontinence, pelvic organ prolapse, vaginal surgery and neuromodulation.

She received her medical degree from Indiana University School of Medicine in Indianapolis. She completed her residency in Obstetrics and Gynecology at Good Samaritan Hospital in Cincinnati, Ohio, as well as research fellowships in advanced pelvic surgery and advanced endoscopic surgery and urogynecology at Cleveland Clinic.