Continence Pessary Versus Disposable Intravaginal Device Trial

NCT03174431 | Completed Results FDA Device

• 1 other identifier: SUI_Continence Pessary Trial
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Female Stress Incontinence

Outcome Measures

Primary Outcomes (1)

• 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).

  4 weeks

Secondary Outcomes (4)

• Validated Questionnaires

  4 weeks

• Satisfaction With Device

  4 weeks

• Adverse Events

  4 weeks

• 6 Month Follow up

  6 months

Study Arms (2)

Continence Pessary

ACTIVE COMPARATOR

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

Disposable Intravaginal Device

ACTIVE COMPARATOR

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)

Interventions

Continence Pessary DEVICE

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.

Continence Pessary

Poise Impressa (Disposable Intravaginal Device) 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.

Also known as: Poise Impressa

Disposable Intravaginal Device

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (2)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (13)

• 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.

  PMID: 24463674 BACKGROUND

• 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.

  PMID: 11530119 BACKGROUND

• 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.

  PMID: 20177294 BACKGROUND

• 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.

  PMID: 19434384 BACKGROUND

• 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.

  PMID: 18377862 BACKGROUND

• 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.

  PMID: 12861145 BACKGROUND

• 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.

  PMID: 16021067 BACKGROUND

• 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.

  PMID: 12955337 BACKGROUND

• 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.

  PMID: 2313045 BACKGROUND

• 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.

  PMID: 11744914 BACKGROUND

• 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.

  PMID: 12519665 BACKGROUND

• 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.

  PMID: 16652380 BACKGROUND

• 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.

  PMID: 19937315 BACKGROUND

Results Point of Contact

• Title: Silpa Nekkanti
• Organization: The Ohio State University

silpa.nekkanti@osumc.edu

614-293-4643

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: parallel group design with participants randomized to either DICD or CP (active treatment concurrent control) in a 1:1 allocation ratio for a 4-week treatment period followed by a six-month phone call follow-up to assess continued use and other treatment utilization after the initial study treatment phase.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 2, 2017
• Study Start: August 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 1, 2021
• Last Updated: February 23, 2024
• Results First Posted: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)