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Use of the Leva Incontinence System in Treating Bladder Incontinence.

NCT03536923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-12-12

Study results available
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Summary

This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic with therapist assistance 5x weekly, and at home once daily on weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Leva Incontinence System For Pelvic Floor Muscle strengthening

The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone.

Sponsors & Collaborators

  • Renovia, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Rosenberg, MD · New England Spine Center

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
2017-04-10
Primary Completion
2017-08-12
Completion
2017-10-20
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 NCT03536923 on ClinicalTrials.gov