Clinical trial NCT04143867: The Nolix Feasibility Efficacy and Safety Study
Official title: A Feasibility Efficacy and Safety Study of the Nolix Vaginal Device for the Temporary Management of Stress Urinary Incontinence in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Gynamics LTD
Sponsor class: INDUSTRY
First posted: 2019-10-29
Enrollment: 32
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
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 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean pad weight gain (PWG) change of >50% when comparing the PWG control phase as compared to the Nolix device phase.
timeFrame: 21 days
measure: Device-related adverse events
timeFrame: 21 days
Secondary outcomes:
measure: Change in number of self-reported incontinence episodes.
timeFrame: 21 days
measure: More than 50% reduction in the number of self-reported daily incontinence episodes.
timeFrame: 21 days
measure: Changes in Quality of Life (QoL).
timeFrame: 21 days
measure: Changes in Leak Score.
timeFrame: 21 days
measure: PWG measured continuously.
timeFrame: 21 days
measure: Comfort during Nolix device use.
timeFrame: 21 days
measure: Overall perception of improvement.
timeFrame: 21 days
measure: Overall satisfaction: Patient Satisfaction Question (PSQ)
timeFrame: 21 days
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Boris Fridman, Dr.
role: PRINCIPAL_INVESTIGATOR
References: