Continence Pessary Versus Disposable Intravaginal Device Trial

• ClinicalTrials.gov Identifier: NCT03174431
• Recruitment Status: Unknown
• First Posted: June 2, 2017
• Last Update Posted: June 2, 2017
• Sponsor: Ohio State University
• Collaborator: University of North Carolina, Chapel Hill
• Information provided by (Responsible Party): Silpa Nekkanti, Ohio State University

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

More Information

Publications:

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):141-8. doi: 10.1097/AOG.0000000000000057.

Wilson L, Brown JS, Shin GP, Luc KO, Subak LL. Annual direct cost of urinary incontinence. Obstet Gynecol. 2001 Sep;98(3):398-406.

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):609-17. doi: 10.1097/AOG.0b013e3181d055d4.

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.

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.

Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101.

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.

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. Epub 2003 Jul 25. Erratum in: Int Urogynecol J Pelvic Floor Dysfunct. 2004 May-Jun;15(3):219.

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.

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.

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.

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.

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. Review.

• Responsible Party: Silpa Nekkanti, MD, Ohio State University
• ClinicalTrials.gov Identifier: NCT03174431
• Other Study ID Numbers: SUI_Continence Pessary Trial
• First Posted: June 2, 2017
• Last Update Posted: June 2, 2017
• Last Verified: June 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Urinary Incontinence, Stress; Urinary Incontinence; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations