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An Investigation With an Intra-vaginal Device for Stress Urinary Incontinence

NCT03186651 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2018-04-04

No results posted yet for this study

Summary

This is a prospective, randomized, controlled, two-armed multi-center pre-market trial. Nighty-six (96) subjects will be recruited at sites in Sweden. Patients with diagnosed stress urinary incontinence (SUI), will be considered as potential study participants. After written informed consent has been acquired, a medical and surgical history, a physical examination (including pelvic examination), and a confirmation of the diagnosis of SUI will be performed, followed by a confirmation of the inclusion/exclusion criteria. The study subjects fulfilling all the eligibility criteria will thereafter be randomized 3:1 into either the TVS group or the standard of care (SoC) group.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

TVS

Efficacy of a novel intra-vaginal device for temporary reduction of urine leakage in women suffering from stress urinary incontinence and to evaluate the safety and ease of use.

Sponsors & Collaborators

  • Invent Medic Sweden AB

    lead INDUSTRY

Principal Investigators

  • Aino Fianu Jonasson, MD, PhD · Kvinnokliniken Karolinska sjukhuset

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-27
Primary Completion
2018-02-14
Completion
2018-03-28

Countries

  • Sweden

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 NCT03186651 on ClinicalTrials.gov