Intravaginal Devices for Pelvic Floor Motion
Condition: Pelvic Floor Disorders
MeSH terms: Pelvic Floor Disorders
Study type: Interventional

Summary: 
      The leva and PFDx devices accurately reflect pelvic floor motion consistent with TPUS
      evaluation. During a voluntary PFM contraction, the change in angle from a position of rest
      to maximal effort that is detected by each device is positively correlated with TPUS
      measurements and Modified Oxford scores.
    

Detailed description: 
      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.

      Baseline assessment will be performed at rest, then with 3 maximum-effort voluntary
      contraction (MVC). Ultrasound measurements will include: Anterior-posterior distance (APD) of
      the levator hiatus to the pubic bone (primary aim), levator urethra gap (LUG), distance from
      bladder neck to the pubic bone and distance of the midurethra to the pubic bone. Urethral
      angle at rest and with max contraction will also be measured. The cravioventral shift of the
      levator plate relative to a vertical line of reference relative to the anorectal angle will
      also be measured.

      Leva measurements Subjects will be instructed on proper insertion and placement of the leva
      device. The examiner will assist with device placement, as needed. With the leva inserted,
      subjects will assume a standing position. Subjects will complete a series of pelvic floor
      muscle training (five lifts for 15 seconds of maximum lift, followe by 15 seconds of rest).

      PFDx measurements The examiner will place the PFDx in the vagina, ensuring the ring component
      is positioned at the fornix with the extension running the length of vagina and out of the
      body. With the device retained in the vagina, subjects will assume a standing position. Angle
      measurements will be recorded at rest and with maximal voluntary 'lift-and-squeeze'
      contraction. These measurements will be repeated at least 3 times with 1-minute rest between
      each measurement.
    

Intervention name(s): PFDx device and leva device
Intervention type(s): Device
Intervention description(s): Participants will use the leva device, PFDx device and undergo ultrasound measurements during pelvic floor motion to compare the three measurements.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research