Effectiveness of Kegel Exercise Device in Strengthening Pelvic Floor and Treating Urinary Incontinence (UI)

The objective of the study is to test the device with women who are experiencing symptoms of
pelvic floor weakness, namely urinary incontinence, vaginal laxity and sexual sensation
problems, to assess the changes in pelvic floor muscle strength, before and after the
intervention.

The study device is a pelvic floor exercise device that provides biofeedback and exercise
guidance.

Women who meet the inclusion criteria will be recruited from the regular patients at the
investigation site and given the device to use at home daily for 12 weeks. Subjects will
submit information regarding their experience with the device and self-assessed improvements
in their symptoms. A pelvic examination will be conducted at the start and conclusion of the
study to measure a pelvic floor muscle strength reading.

The research hypothesis is that strength level, subjective assessment of vaginal tightness
and sexual sensations will be greater at the end of the study than at the baseline and the
mean value of frequency and volume of bladder leaks will be less than at the baseline.

Inclusion Criteria:

1. Subject provides written informed consent and HIPAA authorization before any study
procedures are conducted;

2. Experience urinary incontinence and/or vaginal laxity and/or decreased sexual
sensation for a period of 6 weeks or more.

Exclusion Criteria:

1. Subject has any condition or exhibits behavior that indicates to the Principal
Investigator that the Subject is unlikely to be compliant with study procedures and
visits

2. Has had prior surgery for incontinence, prolapse or vaginal tightening

3. Has been diagnosed with pelvic organ prolapse more severe than grade 2

4. Suffers from vaginal penetration difficulties

5. Has had more than 3 urinary tract infections in the past 12 months

6. Has any conditions of the bladder that effect continence

7. Suffer from vaginal/vulvar/pelvic pain

8. Is currently taking any medication for incontinence

9. Is pregnant or trying to become pregnant

10. Has given birth less than 6 weeks prior to enrollment

11. Has been diagnosed obese - BMI > 30

12. Is a heavy smoker - > 20 cigarettes per day

13. Has a history of neurological conditions - Parkinson's, multiple sclerosis and other

14. Suffers from chronic constipation