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

NCT04325477 | Completed

• 1 other identifier: NLX-010
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Urinary Incontinence

Keywords

intravaginal device; pad weight gain; stress urinary incontinence

Outcome Measures

Primary Outcomes (3)

• Continuous percent change in urine leakage

  Continuous percent change in urine leakage is defined as: 100%\*(PWG without Nolix - PWG with Nolix)/PWG without Nolix.

  Pads were measured before and immediately after the 1 hour PWG test

• Change in the dryness of the pad

  Success ("1") if following the 1-hour PWG test, the pad weight increases by no more than 1 gram or Failure ("0") if following the 1-hour test, the pad weight increased by more than 1 gram.

  Pads were measured before and immediately after the 1 hour PWG

• Dichotomous change in urine leakage

  In accordance with FDA recommendations, the clinically meaningful level of improvement in PWG is at least 50%. Therefore, the dichotomous change is defined for each patient as follows: Success ("1"), if continuous percent change in PWG \> 50% or Failure ("0"), if continuous percent change in PWG \< 50%

  Pads were measured before and immediately after the 1 hour PWG

Secondary Outcomes (2)

• Comfort during Nolix use

  1 Day

• Overall satisfaction: Nolix Satisfaction Questionnaire

  1 Day

Study Arms (1)

Nolix Device

EXPERIMENTAL

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

Device: Nolix Device

Interventions

Nolix Device DEVICE

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

Nolix Device

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gynamics LTD: lead

Study Sites (1)

Assuta Medical Center

Haifa, Israel

Location

Related Publications (2)

• Krhut J, Zachoval R, Smith PP, Rosier PF, Valansky L, Martan A, Zvara P. Pad weight testing in the evaluation of urinary incontinence. Neurourol Urodyn. 2014 Jun;33(5):507-10. doi: 10.1002/nau.22436. Epub 2013 Jun 24.

  PMID: 23797972 BACKGROUND

• Naor MS, Kaploun A, Friedman B. A feasibility study with a novel, dynamic, and disposable over-the-counter device for the management of stress urinary incontinence. Neurourol Urodyn. 2021 Feb;40(2):653-658. doi: 10.1002/nau.24598. Epub 2020 Dec 21.

  PMID: 33348425 DERIVED

Related Links

• Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA Staff

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Boris Friedman, Dr

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 27, 2020
• Study Start: October 31, 2017
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)