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Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence

NCT04027335 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-01-20

No results posted yet for this study

Summary

Pilot study to understand the impact of a digital health system, including a phone app and a vaginal probe to treat fecal incontinence in women

Conditions

  • Fecal Incontinence

Interventions

DEVICE

leva

Vaginal device used for pelvic floor muscle exercises

Sponsors & Collaborators

  • Renovia, Inc.

    lead INDUSTRY

Principal Investigators

  • Holly Richter, MD PhD · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-27
Primary Completion
2020-12-21
Completion
2021-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04027335 on ClinicalTrials.gov