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Trial record 2 of 2 for:    Watkins-Conti Products, Inc.

A Feasibility Device Study to Prevent Female Urinary Stress Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03010800
Recruitment Status : Completed
First Posted : January 5, 2017
Results First Posted : November 6, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
University of Oklahoma
Information provided by (Responsible Party):
Watkins Conti Products. Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Stress Incontinence, Female
Interventions Device: With Yoni.Fit
Device: Without Yoni.Fit
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title With Yoni.Fit First Without Yoni.Fit First
Hide Arm/Group Description Yoni.Fit first, then without the Yoni.Fit. Without Yoni.Fit first, then with Yoni.Fit.
Period Title: Initial Assignment
Started 4 4
Completed 4 4
Not Completed 0 0
Period Title: Cross Over
Started 4 4
Completed 4 4
Not Completed 0 0
Arm/Group Title With Yoni.Fit First Without Yoni.Fit First Total
Hide Arm/Group Description With the Yoni.Fit first, then without the Yoni.Fit. Without the Yoni.Fit first, then with the Yoni.Fit. Total of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
4
 100.0%
8
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
4
 100.0%
4
 100.0%
8
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Pad Weight Difference
Hide Description Comparison of urine weight of the pad without Yoni,Fit to the weight of the pad with Yoni.Fit controlling for the tare weight.
Time Frame An hour after finishing a liter of liquid
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title With Yoni.Fit Without Yoni.Fit
Hide Arm/Group Description:
Pad weights for with the Yoni.Fit
Pad weights without Yoni.Fit.
Overall Number of Participants Analyzed 8 8
Measure Type: Number
Unit of Measure: grams
Subject #1 0.0 0.0
Subject #2 0.0 0.3
Subject #3 0.1 2.4
Subject #4 0.3 0.4
Subject #5 0.1 10.5
Subject #6 0.1 6.0
Subject #7 0.2 0.0
Subject #8 17.3 9.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection With Yoni.Fit, Without Yoni.Fit
Comments

Null hypothesis is that the pad weights With Yoni.Fit and Without Yoni.Fit are equivalent.

A one-sided Wilcoxson paired T-test of the group means will be performed. If the p-value is significant, the null hypothesis will be rejected.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0469
Comments One subject experienced incontinence with the Yoni.Fit in place (#8) (9.2 g Pad Wt. Without and 17.3 g Pad Wt. With). This was attributed to incorrect Yoni.Fit sizing. This subject was not included in the p-value calculation.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 1 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title With Yoni.Fit Without Yoni.Fit
Hide Arm/Group Description Those subjects assigned to use the Yoni.Fit first Those subjects assigned to use the pad first.
All-Cause Mortality
With Yoni.Fit Without Yoni.Fit
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
With Yoni.Fit Without Yoni.Fit
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
With Yoni.Fit Without Yoni.Fit
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Hurst
Organization: Oklahoma University Health Science Center
Phone: 405-271-3930
EMail: Robert-Hurst@ouhsc.edu
Layout table for additonal information
Responsible Party: Watkins Conti Products. Inc.
ClinicalTrials.gov Identifier: NCT03010800    
Other Study ID Numbers: WCP001
First Submitted: December 27, 2016
First Posted: January 5, 2017
Results First Submitted: May 8, 2017
Results First Posted: November 6, 2017
Last Update Posted: January 18, 2018