The Nolix Feasibility Efficacy and Safety Study

A Feasibility Efficacy and Safety Study of the Nolix Vaginal Device for the Temporary Management of Stress Urinary Incontinence in Women

This study is an open label, prospective, feasibility study with the Nolix device used for temporary treatment of Stress Urinary Incontinence (SUI) in subjects, serving as their own controls.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Nolix Device

Detailed Description

This is an open label, prospective, feasibility study with the Nolix device used in subjects with SUI, serving as their own controls. The objective of this study is to evaluate the effectiveness (both objective and subjective) and safety of the Nolix device when used for the temporary management of SUI in women. In addition, the study is aimed to evaluate changes in the quality of life (QoL) and comfort during use of the Nolix device. The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >-50% of the mean %PWG change during the last 7 days of the treatment phase as compared to the control phase. Additional effectiveness endpoints include the number of self-reported SUI episodes per week, the percentage of subjects who experience a greater than -50% change in the number of self-reported daily incontinence episodes, as well as the changes in the QoL, leak scores and overall satisfaction levels. The safety of the Nolix device is also evaluated by assessing the adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Carmel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Females aged 22 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nolix Device; Comparing use of device to non-treatment (pads only) phase	Device: Nolix Device; For temporary management of SUI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean pad weight gain (PWG) change of >50% when comparing the PWG control phase as compared to the Nolix device phase.	The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >50% of the mean %PWG reduction during the last 7 days of the treatment phase as compared to the control phase.	21 days
Device-related adverse events	Discomfort / pain, vaginal irritation or itching, vaginal spotting, vaginal or urinary tract infections	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of self-reported incontinence episodes.	Change in number of self-reported incontinence episodes per week from the control period to the Nolix device use period.	21 days
More than 50% reduction in the number of self-reported daily incontinence episodes.	Percentage of subjects who experience a greater than 50% reduction in the number of self-reported daily incontinence episodes from the baseline period to the Nolix device use period.	21 days
Changes in Quality of Life (QoL).	The QoL Questionnaire (measured on a 0-100 scale) will be performed at baseline and after the device-use period and refer to areas which may have been influenced or changed by accidental urine loss and/or prolapse. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.	21 days
Changes in Leak Score.	Changes in Leak Score from the baseline period to the Nolix device use period, as measured using the Leak Score Questionnaire. The Leak Score Questionnaire will be performed (on a 0-3 scale) to evaluate the subjective perception of incontinence during eight effort demanding activities: coughing, laughing, sneezing, jumping, lifting heavy objects, walking, running, and going to the gym.	21 days
PWG measured continuously.	PWG measured continuously (as opposed to responder analysis), using the same definition of PWG as described above, without transformation to percent.	21 days
Comfort during Nolix device 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).	21 days
Overall perception of improvement.	Overall perception of improvement following the use of the Nolix device, as measured using the Patient Global Impression of Improvement (PGI-I) Scale, measured on a 7-point scale (where 1 is the most positive response and 7 the most negative response).	21 days
Overall satisfaction: Patient Satisfaction Question (PSQ)	Overall satisfaction with the use of the Nolix device, as measured using the Patient Satisfaction Question (PSQ),selecting one of the following answers: 'Completely'; 'Somewhat'; or 'Not at all'.	21 days

Collaborators and Investigators

• Sponsor: Gynamics LTD
• Investigators: Principal Investigator: Boris Fridman, Dr., Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 27, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: NLX-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All personal data gathered in this trial will be treated in strictest confidence by investigators, monitors, sponsor's personnel and independent ethics committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No