The Nolix Feasibility Efficacy and Safety Study

NCT04143867 | Completed

• 1 other identifier: NLX-002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in number of self-reported incontinence episodes.

  21 days

• More than 50% reduction in the number of self-reported daily incontinence episodes.

  21 days

• Changes in Quality of Life (QoL).

  21 days

• Changes in Leak Score.

  21 days

• PWG measured continuously.

  21 days

Study Arms (1)

Nolix Device

EXPERIMENTAL

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

Device: Nolix Device

Interventions

Nolix Device 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 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.

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)

Carmel Medical Center

Haifa, Israel

Location

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 Fridman, Dr.

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• 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: October 22, 2019
• First Posted: October 29, 2019
• Study Start: January 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)