Validity (and Reliability) of Two Forms of an Accelerometer-Based Intravaginal Device for Detecting Pelvic Floor Motion

Thirty women 18 years or older will be recruited from OB/GYN, FPMRS or other clinics. Following informed consent and successful screening, subjects will undergo testing as outlined below. Five subjects (all will be invited until five subjects have agreed) will return to clinic in 1-2 weeks to undergo repeat testing using all modalities.

After obtaining informed consent, subject information will be collected, including demographic data, BMI, and medical history (including ob/gyn history). Subjects will complete urinalysis for pregnancy. Subjects will also complete the Pelvic Floor Distress Inventory (PFDI-20) questionnaire. All subjects will undergo a complete pelvic examination including pelvic organ prolapse quantification (POP-Q), a digital assessment of PFM strength (Modified Oxford Scale) and receive a TPUS. Subjects will also complete a series of PFM contractions using the leva and PFDx devices to measure angle changes, and undergo vaginal assessment with a perineomter.

Pelvic floor muscle assessment Prior to recording device measurements, a correct pelvic floor muscle contraction will be verified via manual pelvic floor assessment. Subjects will be instructed to perform a "lift-and-squeeze" maneuver of the pelvic floor, and correct PFM contraction will be verified by the primary examiner (LHQ). PFM strength will then be assessed via digital palpation by the examiner inserting the first and/or second fingers approximately 4 cm into the vagina and palpating the right and left PFM during contraction. Strength will be graded according to the 6-point Modified Oxford Scale (0=no contraction; 1='flicker'; 2=weak; 3=moderate; 4=good; 5=strong). The mean score of the right and left sides of the vagina will be calculated and used for correlation analysis.

Perineometry PFM strength will be measured using a Peritron™ perineometer, which is a 28mm diameter compressible probe connected to a handheld microprocessor. It provides readings of pelvic floor contraction in cm of H20 with precision up to one decimal point, and it has been demonstrated to show reproducible and reliable measurements. The resting vaginal pressure and two peak pressures will be measured. For this study, PFM strength is defined as the augmented vaginal pressure, calculated by measuring the average of 2 peak pressures minus the resting vaginal pressure.

TPUS measurements TPUS imaging will be completed at the time of the study visit using the BK Medical Ultrafocus (Peabody, MA) and 8802 transperineal transducer. The probe will be covered with ultrasound gel and a probe cover. All ultrasound studies will be performed in the office setting with the patient in the dorsal lithotomy position, with hips flexed and abducted. No preparation is required, and no rectal or vaginal contrast will be used. Patients will be instructed to arrive at the office with a partially full bladder and to avoid excessive pressure on surrounding structures that might distort the anatomy. In the sagittal view, dynamic ultrasound parameters will be measured relative to a horizontal reference line at the level of the infero-posterior margin of the pubic symphysis. Dynamic images will be obtained during PFM contractions and at rest. At least 3 cycles of PFM contraction and relaxation will be recorded for each individual.