MedTrace Logo

Pelvital Stress Urinary Incontinence Training Device: P-SUIT

NCT02954042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-04-14

No results posted yet for this study

Summary

The purpose of this investigation is to compare the clinical benefits of using the Pelvital product, in comparison to a sham procedure as a noninvasive treatment for female incontinence

Conditions

  • Incontinence

Interventions

DEVICE

Pelvital probe

Pelvital probe

DEVICE

Placebo Probe

Placebo Probe

Sponsors & Collaborators

  • Pelvital USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Nissrine Nakib, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2019-10-30
Completion
2019-10-30
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 NCT02954042 on ClinicalTrials.gov