NCT03010800

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

January 4, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2017

Completed
6 months until next milestone

Results Posted

Study results publicly available

November 6, 2017

Completed
Last Updated

January 18, 2018

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

December 27, 2016

Results QC Date

May 8, 2017

Last Update Submit

January 4, 2018

Conditions

Stress Incontinence, Female

Outcome Measures

Primary Outcomes (1)

  • Pad Weight Difference

    Comparison of urine weight of the pad without Yoni,Fit to the weight of the pad with Yoni.Fit controlling for the tare weight.

    An hour after finishing a liter of liquid

Study Arms (2)

With Yoni.Fit

EXPERIMENTAL

Subjects will perform the Abbreviated Pad Test with the Yoni.Fit first, then without the Yoni.Fit.

Device: With Yoni.Fit

Without Yoni.Fit

EXPERIMENTAL

Subjects will perform the Abbreviated Pad Test without the Yoni.Fit first, then with the Yoni.Fit.

Device: Without Yoni.Fit

Interventions

With Yoni.FitDEVICE

Abbreviated Pad Test with Yoni.Fit first, then without Yoni.Fit.

With Yoni.Fit
Without Yoni.FitDEVICE

Abbreviated Pad Test without Yoni.Fit, then with Yoni.Fit.

Without Yoni.Fit

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (5)

  • 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. Int Neurourol J. 2015 Dec;19(4):246-58. doi: 10.5213/inj.2015.19.4.246. Epub 2015 Dec 28.

    PMID: 26739179BACKGROUND

  • Ellington DR, Erekson EA, Richter HE. Outcomes of Surgery for Stress Urinary Incontinence in the Older Woman. Clin Geriatr Med. 2015 Nov;31(4):487-505. doi: 10.1016/j.cger.2015.06.006. Epub 2015 Jul 26.

    PMID: 26476111BACKGROUND

  • Jones KA, Harmanli O. Pessary use in pelvic organ prolapse and urinary incontinence. Rev Obstet Gynecol. 2010 Winter;3(1):3-9.

    PMID: 20508777BACKGROUND

  • Bradley CS, Rahn DD, Nygaard IE, Barber MD, Nager CW, Kenton KS, Siddiqui NY, Abel RB, Spino C, Richter HE. 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. Neurourol Urodyn. 2010 Jun;29(5):727-34. doi: 10.1002/nau.20818.

    PMID: 19787711BACKGROUND

  • Hahn I, Fall M. Objective Quantification of Stress Urinary Incontinence: A Short Reproducible, Provocative Pad-Test. Neurourology and urodynamics. 1991;10:475-81.

    BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Robert Hurst
Organization
Oklahoma University Health Science Center
Robert-Hurst@ouhsc.edu
405-271-3930

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2016

First Posted

January 5, 2017

Study Start

January 4, 2017

Primary Completion

February 28, 2017

Study Completion

May 3, 2017

Last Updated

January 18, 2018

Results First Posted

November 6, 2017

Record last verified: 2017-06

Locations

US(1)