A Feasibility, Short-term Study With a Novel, Dynamic, and Disposable Over the Counter Device for Stress Urinary Incontinence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gynamics LTD
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Continuous percent change in urine leakage
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Nolix Device
Comparing use of device to non-treatment (pads only) phase
Intervention: Nolix Device (Device)
Outcomes
Primary Outcomes
Continuous percent change in urine leakage
Time Frame: Pads were measured before and immediately after the 1 hour PWG test
Continuous percent change in urine leakage is defined as: 100%\*(PWG without Nolix - PWG with Nolix)/PWG without Nolix.
Dichotomous change in urine leakage
Time Frame: Pads were measured before and immediately after the 1 hour PWG
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%
Change in the dryness of the pad
Time Frame: Pads were measured before and immediately after the 1 hour PWG
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.
Secondary Outcomes
- Comfort during Nolix use(1 Day)
- Overall satisfaction: Nolix Satisfaction Questionnaire(1 Day)