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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
For temporary management of SUI
Carmel Medical Center
Haifa, Israel
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.
Time frame: 21 days
Device-related adverse events
Discomfort / pain, vaginal irritation or itching, vaginal spotting, vaginal or urinary tract infections
Time frame: 21 days
Change in number of self-reported incontinence episodes.
Change in number of self-reported incontinence episodes per week from the control period to the Nolix device use period.
Time frame: 21 days
More than 50% reduction in the number of self-reported daily incontinence episodes.
Percentage of subjects who experience a greater than 50% reduction in the number of self-reported daily incontinence episodes from the baseline period to the Nolix device use period.
Time frame: 21 days
Changes in Quality of Life (QoL).
The QoL Questionnaire (measured on a 0-100 scale) will be performed at baseline and after the device-use period and refer to areas which may have been influenced or changed by accidental urine loss and/or prolapse. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.
Time frame: 21 days
Changes in Leak Score.
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Changes in Leak Score from the baseline period to the Nolix device use period, as measured using the Leak Score Questionnaire. The Leak Score Questionnaire will be performed (on a 0-3 scale) to evaluate the subjective perception of incontinence during eight effort demanding activities: coughing, laughing, sneezing, jumping, lifting heavy objects, walking, running, and going to the gym.
Time frame: 21 days
PWG measured continuously.
PWG measured continuously (as opposed to responder analysis), using the same definition of PWG as described above, without transformation to percent.
Time frame: 21 days
Comfort during Nolix device use.
Comfort during Nolix device use will be measured through the Satisfaction Questionnaire, using a 10-point scale (where 1 is the most negative response and 10 the most positive, during the use of the device).
Time frame: 21 days
Overall perception of improvement.
Overall perception of improvement following the use of the Nolix device, as measured using the Patient Global Impression of Improvement (PGI-I) Scale, measured on a 7-point scale (where 1 is the most positive response and 7 the most negative response).
Time frame: 21 days
Overall satisfaction: Patient Satisfaction Question (PSQ)
Overall satisfaction with the use of the Nolix device, as measured using the Patient Satisfaction Question (PSQ),selecting one of the following answers: 'Completely'; 'Somewhat'; or 'Not at all'.
Time frame: 21 days