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

Gynamics

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: Nolix Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04325477

NLX-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

26 participants in 1 patient group

Nolix Device

Experimental group

Description:

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

Treatment:

Device: Nolix Device