91: Biomechanical mapping of pelvic floor restoration after prolapse surgery

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The objective of this study is to explore biomechanical transformations of the female pelvic floor after pelvic organ prolapse (POP) surgeries. The prospective multi-center Phase III clinical trial (NCT02925585) was designed to explore changes in tissue elasticity, pelvic support structure strengths and pelvic muscle functions after POP surgeries. To date, 105 subjects were enrolled at five clinical sites, each with planned surgical procedures as the best fit proposed for the specific pelvic conditions by an urogynecologist and accepted by the patient. The applied surgical procedure set includes: supracervical hysterectomy, total hysterectomy, sacrocolpopexy, uterosacral ligament suspension, anterior and posterior colporrhaphy with and without graft augmentation, enterocele repair and perineorrhaphy. A Vaginal Tactile Imager (VTI) was used to acquire comprehensive data for biomechanical mapping of the pelvic floor. The VTI measurements were completed at rest with manually applied deflection pressures to vaginal walls and with pelvic muscle contractions. An analytical software package allowed automated computation of 52 biomechanical parameters for 8 VTI test procedures: (1) probe insertion, (2) elevation, (3) rotation, (4) Valsalva maneuver, (5-6) voluntary muscle contractions in 2 planes, (7) relaxation, and (8) reflex contraction at cough. Patient pelvic pre- and post-operative (4+ months) conditions and VTI data were analyzed to identify statistically significant changes in the biomechanical parameters by paired t-test. Interim analysis of 137 completed to date POP surgical procedures on 54 subjects demonstrates that 25 of 52 biomechanical parameters have statistically significant changes (p<0.05) with identified surgical procedures. A wide range of patient demographics across geographic regions and uses of a range of surgical approaches was observed. The proposed biomechanical mapping data are being integrated into a mathematical model to predict outcome of a surgical treatment based on the patient-specific pelvis clinical history/conditions and VTI preoperative examination results. This study represents the largest set of pelvic biomechanical data collected prospectively before and after POP surgery to date. The observed changes in parameters collected before and after the POP surgery suggest that the proposed biomechanical mapping could be effectively used to complement other diagnostic approaches and aid in choice of indication and assessment of the intervention across varied clinical conditions and procedures.