A Feasibility Study With a Novel, Dynamic and Disposable Over-the-counter Device for Stress Urinary Incontinence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-31

Study Completion Date

2018-10-30

Brief Summary

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This study was designed as an open label, feasibility, single-center, cross-over prospective study in women with stress urinary incontinence. Subjects served as their own control.

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Detailed Description

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The primary objectives of this feasibility study were to evaluate the short-term efficacy of the Nolix device by measuring a reduction of SUI following a modified 1-hour PWG test and to measure the safety of the Nolix device based on adverse events that were reported by subjects during the study. The secondary objective was to assess usability and patient satisfaction using the Nolix device.

Conditions

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Stress Urinary Incontinence

Study Design

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Intervention Model

SEQUENTIAL

A prospective one-arm study with subjects serving as their own control.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nolix Device

Comparing use of device to non-treatment (pads only) phase

Group Type EXPERIMENTAL

Nolix Device

Intervention Type DEVICE

The Nolix device is a single use, dynamic, and soft flexible intra-vaginal device for temporary management of SUI

Interventions

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Nolix Device

The Nolix device is a single use, dynamic, and soft flexible intra-vaginal device for temporary management of SUI

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Females aged 21 and above
* Suffering from Stress Urinary Incontinence
* Women who can understand the nature of the study, are physically able to perform all required tasks and consent to it by signing a written Informed Consent Form prior to participation in the study

Exclusion Criteria

* Age ≤ 21 years
* Pregnant or planning to become pregnant during the study.
* Vaginal birth or Cesarean section for the last 3 months prior to entering the study.
* Severely atrophic vagina.
* A history of Toxic Shock Syndrome (TSS).
* Active urinary tract or vaginal infection.
* Patients prone to recurrent vaginal or urinary tract infections (i.e. more than 3 times in the past year).
* Has experienced unusual or unexpected vaginal bleeding within the last 6 months.
* Vaginal surgery within the last 3 months prior to entering the study.
* Has experienced difficulties with the use of intra-vaginal devices, including tampons.
* Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Average daily PWG as measured in the baseline pad period is less than 4 grams /12 hours.

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No