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Predictive Value of Biomechanical Mapping for Pelvic Organ Prolapse Surgery

Egorov, Vladimir PhD*; Takacs, Peter MD, PhD; Shobeiri, S. Abbas MD; Hoyte, Lennox MD§; Lucente, Vincent MD; van Raalte, Heather MD; Sarvazyan, Noune PhD*

Female Pelvic Medicine & Reconstructive Surgery: October 14, 2019 - Volume Publish Ahead of Print - Issue - p
doi: 10.1097/SPV.0000000000000786
Original Article: PDF Only
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Objective This study examined biomechanical changes in pelvic floor after urogynecological surgery.

Methods This multisite clinical study was designed to explore changes in tissue elasticity, pelvic support, and certain functions (contractive strength, muscle relaxation speed, muscle motility) after pelvic organ prolapse (POP) surgery. A biomechanical mapping of the pelvic floor was performed before and 4 to 6 months after the surgery. The biomechanical data for 52 parameters were acquired by vaginal tactile imaging for manually applied deflection pressures to vaginal walls and pelvic muscle contractions. The two-sample t-test (P < 0.05) was used to test the null hypothesis that presurgery data in group 1 (positive parameter change after surgery) and presurgery data in group 2 (negative parameter change after surgery) belonged to the same distribution.

Results A total of 78 subjects with 255 surgical procedures were analyzed across 5 participating clinical sites. All 52 t-tests for group 1 versus group 2 had P value in the range from 4.0 × 10−10 to 4.3 × 10−2 associating all of the 52 parameter changes after surgery with the presurgical conditions. The P value of before and after surgery correlation ranged from 3.7 × 10−18 to 1.6 × 10−2 for 50 of 52 tests, with Pearson correlation coefficient ranging from −0.79 to −0.27. Thus, vaginal tactile imaging parameters strongly correlated weak pelvic floor presurgery with the positive POP surgery outcome of improved biomechanical properties.

Conclusions Pelvic organ prolapse surgery, in general, improves the biomechanical conditions and integrity of the weak pelvic floor. The proposed biomechanical parameters can predict changes resulting from POP surgery.

From the *Artann Laboratories, Trenton, NJ

Eastern Virginia Medical School, Norfolk, VA

INOVA Fairfax Hospital, Falls Church

§The Pelvic Floor Institute, Tampa, FL

The Institute for Female Pelvic Medicine and Reconstructive Surgery, Allentown, PA

Princeton Urogynecology, Princeton, NJ.

Correspondence: Vladimir Egorov, PhD, Artann Laboratories, 1457 Lower Ferry Rd, Trenton, NJ 08618. E-mail: vegorov@artannlabs.com.

Research reported in this publication was supported by the National Institute on Aging of the National Institutes of Health under awards number SB1AG034714. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Vladimir Egorov is a co-founder and a CEO of Advanced Tactile Imaging; Peter Takacs, S. Abbas Shobeiri, Lennox Hoyte, and Vincent Lucente have no conflicts of interest; Heather van Raalte is a minor shareholder in Advanced Tactile Imaging; and Noune Sarvazyan is a major shareholder in Artann Laboratories.

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.