Clinical trial NCT04325477: A Feasibility Study With a Novel, Dynamic and Disposable Over-the-counter Device for Stress Urinary Incontinence
Official title: A Feasibility, Short-term Study With a Novel, Dynamic, and Disposable Over the Counter Device for Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: intravaginal device
pad weight gain
stress urinary incontinence
Lead sponsor: Gynamics LTD
Sponsor class: INDUSTRY
First posted: 2020-03-27
Enrollment: 26
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: A prospective one-arm study with subjects serving as their own control.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Continuous percent change in urine leakage
timeFrame: Pads were measured before and immediately after the 1 hour PWG test
measure: Change in the dryness of the pad
timeFrame: Pads were measured before and immediately after the 1 hour PWG
measure: Dichotomous change in urine leakage
timeFrame: Pads were measured before and immediately after the 1 hour PWG
Secondary outcomes:
measure: Comfort during Nolix use
timeFrame: 1 Day
measure: Overall satisfaction: Nolix Satisfaction Questionnaire
timeFrame: 1 Day
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Assuta Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Boris Friedman, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krhut J, Zachoval R, Smith PP, Rosier PF, Valansky 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.
citation: Naor MS, Kaploun A, Friedman B. A feasibility study with a novel, dynamic, and disposable over-the-counter device for the management of stress urinary incontinence. Neurourol Urodyn. 2021 Feb;40(2):653-658. doi: 10.1002/nau.24598. Epub 2020 Dec 21.