A Feasibility Device Study to Prevent Female Urinary Stress Incontinence
Condition: Stress Incontinence, Female
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      This study will test the acute efficacy of an investigational device (Yoni.Fit) in a clinical
      trial of women with incontinence in a standardized set of challenges performed with and
      without the device in place.
    

Detailed description: 
      1. Potential subjects will be pre-qualified by a 6-item questionnaire, the validated
           Questionnaire for Urinary Incontinence Diagnosis (QUID). This questionnaire has 3
           questions each referring to the seriousness of Stress Urinary Incontinence (SUI) and of
           Urge Urinary Incontinence (UUI). Subjects will be accepted if their SUI score is 5 or
           greater and is greater than the UUI score. For privacy reasons, these scores will not be
           retained. Subjects will then be given an appointment. Subjects will be instructed to
           wear comfortable athletic type wear and not to drink any fluid for two hours prior to
           their appointment.

        2. When subjects appear for their appointment, subjects will be administered the informed
           consent by the Study Coordinator. All paperwork will be pre-numbered with a code that
           will link to the subject name. The key will be kept confidential by the Study
           Coordinator. They will be instructed to empty their bladders and will be given a liter
           of water or other drink and instructed to drink it over a 15-20 minute time period. An
           abbreviated patient history will be obtained for the purpose of establishing whether the
           subject meets the inclusion criteria and is not disqualified by meeting the exclusion
           criteria. The subject will again fill out the QUID questionnaire. The inclusion criteria
           are a SUI score of 5 or greater, predominately SUI (SUI score>UUI score) and age between
           25 and 65. Exclusion criteria are predominantly UUI, prolapse greater than mild,
           hysterectomy or other pelvic floor surgery other than a Caesarian section, diabetes,
           pregnant, BMI>35 or unable to perform ten "jumping jack" exercises. Patients will be
           administered three additional questionnaires in order to compute a Severity Score. These
           questionnaires are the Urinary Distress Inventory (UDI), Urinary Impact Questionnaire
           (UIQ) and the Incontinence Severity Index (ISI). The scores will be multiplied together
           to provide the Severity Score.

        3. Patients will be randomized to Group A or Group B to participate in an abbreviated Pad
           Test. Group A will perform the test with the Yoni.Fit device in place then repeat the
           test without the device. Group B will perform the test without the Yoni.Fit device in
           place then repeat the test with the device in place. This test has been validated (5).
           An hour after finishing the liter of liquid, the subject is given a tared incontinence
           pad, which is then put in place. She then engages in the following mild exercise
           challenges..

             1. Stand from sitting 10 times.

             2. Cough vigorously while standing.

             3. Bend down to pick up small object.

             4. Perform ten jumping jacks. The subject then will remove pad, place into bag and
                seal. The Experimenter will then weigh pad. The subjects will be randomized so that
                half will perform the Abbreviated Pad Test with the Yoni.Fit device in place
                followed by repeating without the device in place. The other half will perform the
                challenges in the reverse order.

        4. The experimenter will calculate a change in score, which is the weight of the pad worn
           without the device in place minus the tare weight of the pad divided by the weight of
           the pad with the device in place minus the tare weight of the pad. In case no urine is
           released with the device in place, the Improvement Score will be defined as "1000". A
           Release Change will also be calculated as the net weight without the device in place
           minus the weight with the device in place divided by the net weight released without the
           device in place.
    

Intervention name(s): With Yoni.Fit; Without Yoni.Fit
Intervention type(s): Device; Device
Intervention description(s): Abbreviated Pad Test with Yoni.Fit first, then without Yoni.Fit.; Abbreviated Pad Test without Yoni.Fit, then with Yoni.Fit.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention