Randomized, Crossover Feasibility Study of a Device to Prevent Female Urinary Stress Incontinence
Phase: NA
Conditions: Stress Incontinence, Female
Sponsor: Watkins Conti Products. Inc.

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A Device to Prevent Female Urinary Stress Incontinence 
Principal Investigator: Robert E. Hurst, PhD, Department of Urology. 
Sponsor: Watkins-Conti Products, Inc. 
Background and Significance of Study 
Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) are growing problems 
globally that not only cost health care systems large amounts of money, but severely degrade 
the quality of life (QoL) of an estimated 40 million women in the United States alone.  Although 
surgical solutions can succeed in ameliorating symptoms associated with SUI and POP, surgery 
is not without risks and complications and may even leave the patient in a worse situation than 
before treatment (1, 2). The FDA issued a Public Health Notification regarding surgical mesh 
placed through the vagina (transvaginal placement) to treat POP and SUI. The FDA identified 
serious and frequent complications including mesh erosion through the vagina, pain, infection, 
bleeding, discomfort during intercourse, organ perforation, urinary problems, recurrent prolapse, 
neuro-muscular problems, vaginal scarring/shrinkage & emotional problems.  Most surgical 
complications require intervention including medical, additional surgical treatment and 
hospitalization. The pessary, which is most commonly used for management of female POP but 
also has been used for SUI, does present a viable non-surgical option for treating SUI and POP. 
Pessaries have few complications and side effects, however these devices are traditionally 
placed in the vagina for weeks at a time. Ideally the design should allow for easy removal and 
insertion by the patient (3).  Difficulty with self-removal and insertion of the pessary and loss 
during defecation (Colpexin) may be limiting widespread use of the devices. Currently use of 
pessaries equates to a life-long commitment of office visits every 2 to 3 months.  
Watkins-Conti Products, Inc., has developed a simple design that solves many of these 
problems and could provide a simple, inexpensive solution for SUI for many women. The 
Collapsible Cone-Shaped Intra-Vaginal Urinary Incontinence Support Device (Yoni.Fit) from 
100% medical grade silicone, places pressure on the urethral sphincter while supporting pelvic 
organs, thus eliminating or significantly reducing urine leakage. Inspired by the ring pessary, the 
simple yet effective design of the collapsible device Yoni.Fit is user friendly, light weight and 
less difficult to hold in the vagina than the Colpexin. Yoni.fit is believed to assist with 
strengthening the pelvic floor like the Colpexin while supporting anatomy like the pessary, 
reducing the need for invasive surgeries altogether.  
In order to support applications for Small Business Innovation Research funding and for investor 
funding, Watkins-Conti Products proposes to demonstrate short term efficacy with patients 
suffering from SUI for reduced or eliminated leakage against a standardized battery of 
challenges as a primary endpoint.  Ease of use and support of anatomy with use of Yoni.Fit will 
serve as secondary endpointSpecific Aims- 
Aim: Test the acute efficacy of Yoni-Fit in a clinical trial of unselected women with 
incontinence in a standardized set of challenges performed with and without Yoni-Fit in 
place.  
Protocol 
The flow chart for the study is shown in the figure below. 
 
 

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1. Subjects will be recruited in two ways. First, subjects will be referred from the patient 
bases of two physicians at the OUHSC who treat incontinence. These are Dr. Lieschen 
Quiroz of the Department of Obstetrics and Gynecology and Dr. Gennady Slobodov of 
the Department of Urology. The second source will be a campus-wide email announcing 
the study. Regardless of the method, potential subjects will be referred to Ms. Alicia 
Parrett, a research coordinator for the study who is employed by the Department of 
Urology. 
2. Potential subjects will be pre-qualified by a 6-item questionnaire, the Questionnaire for 
Urinary Incontinence Diagnosis (QUID) (4). 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. 
3. When they appear for their appointment, subjects will be administered the informed 
consent. All paperwork will be pre-numbered with a code that will link to the subject 
name. They 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, BMI>35 or unable to perform ten 

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“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. 
4. Patients will then participate in an abbreviated Pad Test. 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..  
a. Stand from sitting 10 times. 
b. Cough vigorously while standing. 
c. Bend down to pick up small object. 
d. 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. 
5. 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. 
6. Patients will be paid $100 for their participation. 
Data Analysis 
After checking the data for correctness, the data analysis will ensue. Descriptive statistics will be 
calculated and include the mean, median, standard deviation  The improvement scores will be 
correlated with the symptom scores and demographics to provide a preliminary estimate of how 
well the YoniFit performs and possibly to identify parameters that predict less than optimal 
prevention of SUI. 
Budget 
Item 
Amount 
Personnel 
 
     Robert E. Hurst, PhD, PI 
$9,251 
     Alicia Parrett, Clinical Coordinator 
$3,989 
Per subject costs  
$38,250 
IRB application and account set-up 
$3,000 
Supplies and Miscellaneous Costs 
$1,000 
Total direct cost 
$55,490 
Clinical trial IDC (30%) 
$16,647 
Grand Total cost 
$72,137  
 
Budget Justification 

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Dr. Hurst will act as overall PI for this project and will coordinate between Watkins-Conti 
Products and the OUHSC. He will meet with the clinicians as necessary and weekly with Ms. 
Parrett to assess progress and solve any problems. He will also be responsible for preparing the 
IRB application and for the data analysis and for preparing a report. His cost is calculated on the 
basis of 1 person-month (8,33% effort) on a University salary of $80,457 plus 37.98% fringe 
benefits. 
Ms. Parrett will act as the clinical coordinator. In addition to the per subject costs, she will also 
assist with preparing the IRB application, talk to patients who do not qualify, coordinate with the 
physicians and meet with Dr. Hurst. Her cost is calculated on the basis of a salary of $28,907 
with 10% effort plus 37.98% fringe 
The per subject costs are calculated as follows. These amounts are standard charges for 
clinical trials. 
$120 per person for informed consent 
$100 demographics inclusion/exclusion criteria, medical history 
$100 per person for questionnaires administered 
$20 per person for height and weight 
$100 per person for subject stipend 
$125 physician recruitment - per subject recruited by referral of patients. 
$200 per person for coordinator/data management fee 
$765 total per patient costs 
The standard charge for review of an IRB application is $2500. Supplies and Miscellaneous 
Costs include pads, sealable bags, paper, copying and the like. 
 
References 
 
1. 
Huang W, Wang T, Zong H, Zhang Y. Efficacy and Safety of Tension-Free Vaginal Tape-Secur 
Mini-Sling Versus Standard Midurethral Slings for Female Stress Urinary Incontinence: A Systematic 
Review and Meta-Analysis. International neurourology journal. 2015;19(4):246-58. 
2. 
Ellington DR, Erekson EA, Richter HE. Outcomes of Surgery for Stress Urinary Incontinence in the 
Older Woman. Clin Geriatr Med. 2015;31(4):487-505. 
3. 
Jones KA, Harmanli O. Pessary use in pelvic organ prolapse and urinary incontinence. Rev Obstet 
Gynecol. 2010;3(1):3-9. 
4. 
Bradley CS, Rahn DD, Nygaard IE, Barber MD, Nager CW, Kenton KS, et al. The questionnaire for 
urinary incontinence diagnosis (QUID): validity and responsiveness to change in women undergoing non-
surgical therapies for treatment of stress predominant urinary incontinence. Neurourology and 
urodynamics. 2010;29(5):727-34. 
5. 
Hahn I, Fall M. Objective Quantification of Stress Urinary Incontinence: A Short Reproducible, 
Provocative Pad-Test. Neurourology and urodynamics. 1991;10:475-81.