MedTrace Logo

Intravaginal Devices for Pelvic Floor Motion

NCT04826939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-06-13

No results posted yet for this study

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

Interventions

DEVICE

PFDx device and leva device

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

Sponsors & Collaborators

  • Renovia, Inc.

    collaborator INDUSTRY

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Lieschen Quiroz, MD · University of Oklahoma HSC

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2022-09-26
Completion
2022-09-26
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04826939 on ClinicalTrials.gov