The distension properties of the vagina are critical to its function including support of surrounding organs, childbirth, and intercourse. It could be altered by many pathophysiological processes like pregnancy, radiotherapy, and reconstruction surgery. However, there are no clinically available diagnostic tools capable of quantifying the distension properties of the vagina. A proof-of-concept study was designed to assess the feasibility of a novel three-dimensional (3D) ultrasound imaging technique that allows quantitative evaluation of the vagina under distension. Patients with symptomatic pelvic organ prolapse (POP) were recruited for the study. An ultrathin, oversized bag was inserted into the vagina and filled with water using a modified urodynamics system. The instilled water volume and intravaginal pressure were continuously recorded. At maximum vaginal capacity, 3D transintroital ultrasound of the distended vagina and surrounding pelvic structures was performed. Exams were performed in duplicate for each patient, two hours apart (round A and round B). Following the development of a 3D surface model of the distended vagina from each scan, several measurements were obtained, including cross-sectional area, anteroposterior (AP) length and lateral width in the plane of minimum hiatal dimensions (PMHD), AP and lateral diameter at the pubic symphysis (PS) level, maximum and minimum diameter, and maximum vertical length. To assess repeatability between measurements in two rounds, the coefficient of variation (CV) and the intraclass correlation coefficient (ICC) were calculated for each measurement. Correlations between physical measurements including the pelvic organ prolapse quantification (POP-Q) system and vaginal diameter measurements, and obtained metrics were also assessed. Sixteen patients with POP (average age 69 years) completed both rounds of imaging. There was sufficient echogenicity on 3D transintroital ultrasound of the distended vaginal wall to establish boundaries for 3D surface models of the vagina. Overall, all metrics had good or excellent reliability (ICC=0.77-0.93, p<0.05; CV=3%-18%) except maximum diameter, which demonstrated only moderate reliability (ICC=0.67, p=0.092). Strong correlations were found between physical exam measurements including D point of POP-Q, introitus diameter and lateral diameter at apex, and maximum vaginal capacity, maximum vertical length, lateral diameter at PS, minimum diameter, and distended PMHD measurements. The results demonstrated that this system could generate 3D models of the shape of the distended vagina and provide multiple metrics that could be reliably calculated from automated analyses of the models. A novel system for evaluation of the distension properties of the vagina was developed and preliminary evaluation was performed. This system may represent a technique for evaluation of the biomechanical and structural properties of the vagina.
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