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Continence Pessary Versus Disposable Intravaginal Device Trial

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ClinicalTrials.gov Identifier: NCT03174431
Recruitment Status : Unknown
Verified June 2017 by Silpa Nekkanti, Ohio State University.
Recruitment status was:  Not yet recruiting
First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Silpa Nekkanti, Ohio State University

Brief Summary:
This is a multi-centered randomized controlled trial of women with stress urinary incontinence or stress predominant mixed urinary incontinence who desire non-surgical therapy.

Condition or disease Intervention/treatment Phase
Female Stress Incontinence Device: Continence Pessary Device: Poise Impressa (Disposable Intravaginal Device) Not Applicable

Detailed Description:
In this randomized trial, eligible patients who provide written consent for participation will be enrolled. At enrollment we will collect baseline demographic data and ask participants to complete questionnaires and a 3-day bladder diary. Subjects will be randomized in a 1:1 ratio to continence pessary or disposable intravaginal device.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Continence Pessary to a Disposable Intravaginal Device in the Management of Stress Urinary Incontinence: A Randomized Controlled Trial
Estimated Study Start Date : June 15, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Continence Pessary
Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary.
Device: Continence Pessary
Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.

Active Comparator: Disposable Intravaginal Device
Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices.
Device: Poise Impressa (Disposable Intravaginal Device)
In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.
Other Name: Poise Impressa




Primary Outcome Measures :
  1. Treatment success [ Time Frame: 4 weeks ]
    Success of stress urinary incontinence treatment is defined as a response of "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I).


Secondary Outcome Measures :
  1. Change in stress urinary incontinence episodes [ Time Frame: 4 weeks ]
    Change in stress urinary incontinence episodes recorded on a 3-day bladder diary, comparing baseline to end of study

  2. Quality of life questionnaire change scores [ Time Frame: 4 weeks ]
    Questionnaire change scores (from baseline to 4 weeks) on validated questionnaires

  3. Satisfaction with device [ Time Frame: 4 weeks ]
    Satisfaction with device will be assessed using likert scale questionnaires assessing device satisfaction, ease of use, comfort, and likelihood of continued use.

  4. Adverse events [ Time Frame: 4 weeks ]
    Potential adverse events of interest include vaginal discomfort, vaginal bleeding, vaginal infection, vaginal abrasion/laceration, and urinary tract infection (UTI)

  5. Cost [ Time Frame: 4 weeks ]
    Cost calculations will include cost of sizing kit and devices for the disposable intravaginal device and the cost of the device, initial fitting visit and any additional clinic visits for the continence pessary.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-representation of gender identity
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21 years or older (based on disposable intravaginal device manufacturing recommendations).
  • SUI or SUI-predominant mixed incontinence
  • English-speaking

Exclusion Criteria:

  • Pregnancy
  • Current symptomatic urinary tract infection (UTI).
  • Postmenopausal bleeding of unknown etiology
  • Neurogenic bladder
  • Urinary retention (PVR >150mL obtained via bladder scan or catheterization)
  • Pelvic organ prolapse past the hymen as assessed by POP-Q examination
  • Inability to complete questionnaires in English or comply with study protocol
  • Contraindication to pessary or disposable intravaginal device use or prior treatment or experience with either intervention.
  • Prior surgery for stress urinary incontinence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174431


Contacts
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Contact: Silpa Nekkanti, MD 6142934302 silpa.nekkanti@osumc.edu
Contact: Alexis Dieter, MD alexis_dieter@med.unc.edu

Sponsors and Collaborators
Ohio State University
University of North Carolina, Chapel Hill

Publications:

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Responsible Party: Silpa Nekkanti, MD, Ohio State University
ClinicalTrials.gov Identifier: NCT03174431     History of Changes
Other Study ID Numbers: SUI_Continence Pessary Trial
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms