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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325477
• Other study ID #: NLX-010
• Status: Completed
• Phase: N/A
• Start date: October 31, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: April 2020
• Source: Gynamics LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
Israel	Assuta Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Gynamics LTD

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Krhut J, Zachoval R, Smith PP, Rosier PF, Valanský 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Comfort during Nolix use	Comfort during Nolix device use will be measured through the Satisfaction Questionnaire, using a 10-point scale (where 1 is the most negative response and 10 the most positive, during the use of the device).; Comfort during Nolix device use will be measured through the Benefit, Satisfaction, and Willingness to Continue Questionnaire, using a 10-point scale (where 1 is the most negative response and 10 the most positive, during the use of the device)	1 Day
Secondary	Overall satisfaction: Nolix Satisfaction Questionnaire	Overall Satisfaction with the use of the Nolix device, as measured using the Nolix Satisfaction Questionnaire, selecting one of the following answers: 'Completely'; 'Somewhat'; or 'Not at all' (where 'Completely' is the most positive response and 'Not at all' is the most negative response).	1 Day

External Links

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