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

Stress Urinary Incontinence Clinical Trial

Official title:
An Open Randomized Controlled Multicenter Clinical Investigation With an Intra-vaginal Device for Stress Urinary Incontinence in Comparison to Using Standard of Care

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03186651
Study type Interventional
Source Invent Medic Sweden AB
Contact
Status Completed
Phase N/A
Start date February 27, 2017
Completion date March 28, 2018
View Details
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