A Feasibility Device Study to Prevent Female Urinary Stress Incontinence

Randomized, Crossover Feasibility Study of a Device to Prevent Female Urinary Stress Incontinence

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Refusal to sign the informed consent document
• SUI score is less than 5 or is less than the UUI score.
• 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.