Intravaginal Devices for Pelvic Floor Motion

NCT04826939 | Completed FDA Device

• 1 other identifier: 13114
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• Validate leva measurements with transperineal ultrasound (TPUS)

  During a voluntary pelvic floor muscle contraction, the change in angle from a position of rest to maximal effort that is detected by the leva device will be compared to the change in distance from the pubic bone to the levator plate measured by 2D TPUS during the same task.

  Through final study visit (about 3 months)

Secondary Outcomes (9)

• Compare leva angle change measurements with Modified Oxford, Brinks

  Through final study visit (about 3 months)

• Compare PFDx angle change measurements with Modified Oxford, Brinks

  Through final study visit (about 3 months)

• Compare PFDx to a perineometer

  Through final study visit (about 3 months)

• Compare leva to a perineometer

  Through final study visit (about 3 months)

• Determine the test-retest reliability of Manual muscle testing angle measurements over 2 time points

  Through final study visit (about 3 months)

Study Arms (1)

Device usage

EXPERIMENTAL

All participants will complete a survey and undergo an evaluation to test the movement of their pelvic floor with the PFDx device and leva device

Device: PFDx device and leva device

Interventions

PFDx device and leva device DEVICE

Participants will use the leva device, PFDx device and undergo ultrasound measurements during pelvic floor motion to compare the three measurements.

Device usage

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• years of age or older
• Presence of a vagina
• Ability to read and write English
• BMI \<30
• Reports they are able to perform a kegel exercise

You may not qualify if:

• Inability to perform a kegel exercise
• Pelvic organ prolapse greater than ICS POP-Q Stage II
• Known, untreated pelvic, vaginal or urinary tract infection
• Currently pregnant

Sponsors & Collaborators

• University of Oklahoma: lead
• Renovia, Inc.: collaborator

Study Sites (2)

OU Physicians

Oklahoma City, Oklahoma, 73104, United States

Location

University ofOklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Lieschen Quiroz, MD

  University of Oklahoma HSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: April 1, 2021
• Study Start: March 25, 2021
• Primary Completion: September 26, 2022
• Study Completion: September 26, 2022
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)