Stress Incontinence, FemaleNCT03010800
A Feasibility Device Study to Prevent Female Urinary Stress Incontinence
A study testing With Yoni.Fit and Without Yoni.Fit in people with Stress Incontinence, Female, run by Watkins Conti Products. Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Stress Incontinence, Female
- What is being tested?
- With Yoni.Fit and Without Yoni.Fit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2017to 3 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- 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..
- Stand from sitting 10 times.
- Cough vigorously while standing.
- Bend down to pick up small object.
- 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.
- 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.
- Conditions
- Stress Incontinence, Female
- Being tested
- With Yoni.Fit, Without Yoni.Fit
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With Yoni.FitDevice
Abbreviated Pad Test with Yoni.Fit first, then without Yoni.Fit.
Without Yoni.FitDevice
Abbreviated Pad Test without Yoni.Fit, then with Yoni.Fit.
| Study group | Role | What they receive |
|---|---|---|
| With Yoni.Fit | Experimental | Subjects will perform the Abbreviated Pad Test with the Yoni.Fit first, then without the Yoni.Fit. Receives: 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. Receives: Device: Without Yoni.Fit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: An hour after finishing a liter of liquid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start4 Jan 2017
- Primary completion28 Feb 2017
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stress Incontinence, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watkins Conti Products. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Oklahoma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010800
- Sponsor's protocol ID
- WCP001
- Status last verified
- Jun 2017
- First submitted
- 27 Dec 2016
- Last updated
- 18 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26739179Ellington 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.
PubMed 26476111Jones KA, Harmanli O. Pessary use in pelvic organ prolapse and urinary incontinence. Rev Obstet Gynecol. 2010 Winter;3(1):3-9.
PubMed 20508777Bradley 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.
PubMed 19787711Hahn I, Fall M. Objective Quantification of Stress Urinary Incontinence: A Short Reproducible, Provocative Pad-Test. Neurourology and urodynamics. 1991;10:475-81.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Crossover Feasibility Study of a Device to Prevent Female Urinary Stress Incontinence
- ClinicalTrials.gov ID
- NCT03010800
- Acronym / sponsor ID
- WCP001
- Conditions
- Stress Incontinence, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Watkins Conti Products. Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Oklahoma
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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..
- Stand from sitting 10 times.
- Cough vigorously while standing.
- Bend down to pick up small object.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Yoni.Fit | Experimental | Device: With Yoni.FitSubjects will perform the Abbreviated Pad Test with the Yoni.Fit first, then without the Yoni.Fit. |
| Without Yoni.Fit | Experimental | Device: Without Yoni.FitSubjects will perform the Abbreviated Pad Test without the Yoni.Fit first, then with the Yoni.Fit. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| With Yoni.FitAbbreviated Pad Test with Yoni.Fit first, then without Yoni.Fit. | Device | With Yoni.Fit |
| Without Yoni.FitAbbreviated Pad Test without Yoni.Fit, then with Yoni.Fit. | Device | Without Yoni.Fit |
Primary outcome
Pad Weight Difference
Time frame: An hour after finishing a liter of liquid
Comparison of urine weight of the pad without Yoni,Fit to the weight of the pad with Yoni.Fit controlling for the tare weight.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26739179Huang 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.
- Background: PubMed 26476111Ellington 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.
- Background: PubMed 20508777Jones KA, Harmanli O. Pessary use in pelvic organ prolapse and urinary incontinence. Rev Obstet Gynecol. 2010 Winter;3(1):3-9.
- Background: PubMed 19787711Bradley 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.
- BackgroundHahn I, Fall M. Objective Quantification of Stress Urinary Incontinence: A Short Reproducible, Provocative Pad-Test. Neurourology and urodynamics. 1991;10:475-81.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With Yoni.Fit and Without Yoni.Fit in people with Stress Incontinence, Female, run by Watkins Conti Products. Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pad Weight Difference (time frame: An hour after finishing a liter of liquid). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03010800, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.