Biotechnologie und Biomaterialien

Abstrakt

In Vivo Btc-2000™ Measurement of Anterior Vaginal Wall Biomechanical Properties in Prolapse Patients Undergoing Surgical Repair

Elizabeth Mosier, Rachel Jerome, Xian-Jin Xie, Charles CJ Chuong, J Yan, Robert C Eberhart, and Philippe E Zimmern

A non-invasive device, the BTC-2000™, used for skin biomechanical measurements, was adapted for vaginal measurements of prolapsed patients, and tested for intra (IaR) and inter-tester (IrR) reliability, in preparation for a clinical measurement series. Following IRB approval, women aged 35 - 85 with symptomatic stage 2-3 anterior vaginal wall prolapse requiring surgical repair were consented. Twenty four consecutive patients were studied. Under anesthesia, the BTC-2000™ with a 10 mm diameter aperture and a suctioning pressure of 150 mmHg was applied to the anterior vaginal wall below the bladder neck, first with the bladder empty and then filled to 300ml. External, suprapubic measurements were taken as controls. All biomechanical parameters displayed by the instrument were assessed for reliability, including: Laxity (mm/%), Elastic Deformation (mm), Modulus (MPa), Energy Absorption (KPa), and Elasticity (mm). Measurements were made in duplicate by the primary surgeon and a separate, randomly chosen tester. Intra-class correlation coefficient (ICC) was calculated to determine IaR and IrR. The feasibility and reliability of all BTC-2000™ measurements was established for this new application. The calculated biomechanical parameters were not statistically different at the two bladder volumes. ICC calculations showed first and second data collections for both IaR and IrR were not statistically different. ICC IaR values were 0.6 or higher, supporting the claim of reliability. IaR and IrR values for the series of secondary testers were less reliable. Demonstrated feasibility and primary operator reliability pave the way for the first detailed in vivo studies of biomechanical properties in this setting.