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Continence Pessary Versus Disposable Intravaginal Device Trial

Primary Purpose

Female Stress Incontinence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continence Pessary
Poise Impressa (Disposable Intravaginal Device)
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Stress Incontinence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Continence Pessary

    Disposable Intravaginal Device

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Treatment success
    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

    Change in stress urinary incontinence episodes
    Change in stress urinary incontinence episodes recorded on a 3-day bladder diary, comparing baseline to end of study
    Quality of life questionnaire change scores
    Questionnaire change scores (from baseline to 4 weeks) on validated questionnaires
    Satisfaction with device
    Satisfaction with device will be assessed using likert scale questionnaires assessing device satisfaction, ease of use, comfort, and likelihood of continued use.
    Adverse events
    Potential adverse events of interest include vaginal discomfort, vaginal bleeding, vaginal infection, vaginal abrasion/laceration, and urinary tract infection (UTI)
    Cost
    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.

    Full Information

    First Posted
    May 31, 2017
    Last Updated
    June 1, 2017
    Sponsor
    Ohio State University
    Collaborators
    University of North Carolina, Chapel Hill
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03174431
    Brief Title
    Continence Pessary Versus Disposable Intravaginal Device Trial
    Official Title
    A Comparison of Continence Pessary to a Disposable Intravaginal Device in the Management of Stress Urinary Incontinence: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2017 (Anticipated)
    Primary Completion Date
    June 1, 2019 (Anticipated)
    Study Completion Date
    August 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ohio State University
    Collaborators
    University of North Carolina, Chapel Hill

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Female Stress Incontinence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Continence Pessary
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Disposable Intravaginal Device
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Continence Pessary
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Poise Impressa (Disposable Intravaginal Device)
    Other Intervention Name(s)
    Poise Impressa
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Treatment success
    Description
    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).
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Change in stress urinary incontinence episodes
    Description
    Change in stress urinary incontinence episodes recorded on a 3-day bladder diary, comparing baseline to end of study
    Time Frame
    4 weeks
    Title
    Quality of life questionnaire change scores
    Description
    Questionnaire change scores (from baseline to 4 weeks) on validated questionnaires
    Time Frame
    4 weeks
    Title
    Satisfaction with device
    Description
    Satisfaction with device will be assessed using likert scale questionnaires assessing device satisfaction, ease of use, comfort, and likelihood of continued use.
    Time Frame
    4 weeks
    Title
    Adverse events
    Description
    Potential adverse events of interest include vaginal discomfort, vaginal bleeding, vaginal infection, vaginal abrasion/laceration, and urinary tract infection (UTI)
    Time Frame
    4 weeks
    Title
    Cost
    Description
    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.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    self-representation of gender identity
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Silpa Nekkanti, MD
    Phone
    6142934302
    Email
    silpa.nekkanti@osumc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexis Dieter, MD
    Email
    alexis_dieter@med.unc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24463674
    Citation
    Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.
    Results Reference
    background
    PubMed Identifier
    11530119
    Citation
    Wilson L, Brown JS, Shin GP, Luc KO, Subak LL. Annual direct cost of urinary incontinence. Obstet Gynecol. 2001 Sep;98(3):398-406. doi: 10.1016/s0029-7844(01)01464-8.
    Results Reference
    background
    PubMed Identifier
    20177294
    Citation
    Richter HE, Burgio KL, Brubaker L, Nygaard IE, Ye W, Weidner A, Bradley CS, Handa VL, Borello-France D, Goode PS, Zyczynski H, Lukacz ES, Schaffer J, Barber M, Meikle S, Spino C; Pelvic Floor Disorders Network. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):609-617. doi: 10.1097/AOG.0b013e3181d055d4.
    Results Reference
    background
    PubMed Identifier
    19434384
    Citation
    Ziv E, Stanton SL, Abarbanel J. Significant improvement in the quality of life in women treated with a novel disposable intravaginal device for stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):651-8. doi: 10.1007/s00192-009-0824-y. Epub 2009 Mar 11.
    Results Reference
    background
    PubMed Identifier
    18377862
    Citation
    Ziv E, Stanton SL, Abarbanel J. Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence. Am J Obstet Gynecol. 2008 May;198(5):594.e1-7. doi: 10.1016/j.ajog.2008.01.061. Epub 2008 Apr 2.
    Results Reference
    background
    PubMed Identifier
    12861145
    Citation
    Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
    Results Reference
    background
    PubMed Identifier
    16021067
    Citation
    Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
    Results Reference
    background
    PubMed Identifier
    12955337
    Citation
    Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. doi: 10.1007/s00192-003-1063-2. Epub 2003 Jul 25. Erratum In: Int Urogynecol J Pelvic Floor Dysfunct. 2004 May-Jun;15(3):219.
    Results Reference
    background
    PubMed Identifier
    2313045
    Citation
    Herzog AR, Diokno AC, Brown MB, Normolle DP, Brock BM. Two-year incidence, remission, and change patterns of urinary incontinence in noninstitutionalized older adults. J Gerontol. 1990 Mar;45(2):M67-74. doi: 10.1093/geronj/45.2.m67.
    Results Reference
    background
    PubMed Identifier
    11744914
    Citation
    Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. doi: 10.1067/mob.2001.118659.
    Results Reference
    background
    PubMed Identifier
    12519665
    Citation
    Meston CM. Validation of the Female Sexual Function Index (FSFI) in women with female orgasmic disorder and in women with hypoactive sexual desire disorder. J Sex Marital Ther. 2003 Jan-Feb;29(1):39-46. doi: 10.1080/713847100.
    Results Reference
    background
    PubMed Identifier
    16652380
    Citation
    Burgio KL, Goode PS, Richter HE, Locher JL, Roth DL. Global ratings of patient satisfaction and perceptions of improvement with treatment for urinary incontinence: validation of three global patient ratings. Neurourol Urodyn. 2006;25(5):411-7. doi: 10.1002/nau.20243.
    Results Reference
    background
    PubMed Identifier
    19937315
    Citation
    Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
    Results Reference
    background

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    Continence Pessary Versus Disposable Intravaginal Device Trial

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