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.
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 Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
26
The Nolix device is a single use, dynamic, and soft flexible intra-vaginal device for temporary management of SUI
Assuta Medical Center
Haifa, Israel
Continuous percent change in urine leakage
Continuous percent change in urine leakage is defined as: 100%\*(PWG without Nolix - PWG with Nolix)/PWG without Nolix.
Time frame: Pads were measured before and immediately after the 1 hour PWG test
Change in the dryness of the pad
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.
Time frame: Pads were measured before and immediately after the 1 hour PWG
Dichotomous change in urine leakage
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%
Time frame: Pads were measured before and immediately after the 1 hour PWG
Comfort during Nolix 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). Comfort during Nolix device use will be measured through the Benefit, Satisfaction, and Willingness to Continue 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: 1 Day
Overall satisfaction: Nolix Satisfaction Questionnaire
Overall Satisfaction with the use of the Nolix device, as measured using the Nolix Satisfaction Questionnaire, selecting one of the following answers: 'Completely'; 'Somewhat'; or 'Not at all' (where 'Completely' is the most positive response and 'Not at all' is the most negative response).
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Time frame: 1 Day