Comparison of Two Over the Counter Intravaginal Devices for the Treatment of Stress Urinary Incontinence

NCT06698627 | Enrolling By Invitation FDA Device

• 1 other identifier: 23113
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to compare two commercially available over the counter devices for treatment of stress urinary incontinence in a web based format. The main questions it aims to answer

1. 1.What device do women with SUI prefer after using both devices
2. 2.What patient factors help drive this preference if any
3. 3.Is a web-based crossover intervention study feasible

Conditions

Stress Urinary Incontinence in Women

Keywords

stress urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Device Preference

  Women will be asked to rate each device on a 5 point Likert scale of 1-5. The options for responses will include very favorable, favorable, neutral, unfavorable, very unfavorable. The response for each device will then be compared.

  Day 10, Day 20

Secondary Outcomes (9)

• Patient's global improvement in urinary incontinence

  Day 10 and Day 20

• Comparison of reduction in number incontinence episodes

  Daily for 20 days

• Comparison of symptom bother ICIQ-SF

  Day 1, Day 10, Day 20

• Device Satisfaction

  Day 10 and Day 20

• Device Comfort

  Day 10 and Day 20

Other Outcomes (1)

• Continued patient product used after completion of study period

  3 months after intervention completion

Study Arms (2)

Poise Impressa

ACTIVE COMPARATOR

Participants will be asked to use Poise Impressa for 7 days based on package insert

Device: Daily Disposable Continence Device

Revive

ACTIVE COMPARATOR

Participants will be asked to use Revive continence device based on package insert.

Device: Monthly Disposable Continence Device

Interventions

Daily Disposable Continence Device DEVICE

The Poise® Impressa® is an over-the-counter intravaginal device for women over the age of 21 years with SUI. It is a disposable, one-time use tampon-like device that comprises a core, cover, and applicator. The device is inserted and removed like a vaginal tampon and comes in three sizes.

Poise Impressa

Monthly Disposable Continence Device DEVICE

The Revive® is another over the counter vaginal insert for the treatment of SUI. This is a self-deployable, double-loop pessary device.

Revive

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with a history of stress urinary incontinence that have not undergone treatment that desire conservative management.
• years or older
• Report an average loss of urine greater than three episodes per week.
• Ability to receive mail through USPS

You may not qualify if:

• Patient should not be on vacation at time of study and should be performing daily activities.
• Inability to follow packaged instructions for insertion devices chosen to be included within this study
• Pregnancy or plan to become pregnant in the next three months
• Significant vaginal atrophy due to genitourinary syndrome of menopause
• Current use of over-the-counter vaginal insertion device for treatment of stress urinary incontinence
• Post-menopausal bleeding
• Participants that report visible prolapse and/or bother symptoms of prolapse
• Bladder modifying medications
• Unable to use incontinence device per package instructions
• Given birth in the past three months
• Had vaginal surgery in the last three months
• IUD placement in the past 6 months
• Vaginal infection or UTI that is active
• Undergoing pelvic floor physical therapy
• Had vaginal surgery within the last three months

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37211, United States

Location

Related Publications (7)

• McKay HG, King D, Eakin EG, Seeley JR, Glasgow RE. The diabetes network internet-based physical activity intervention: a randomized pilot study. Diabetes Care. 2001 Aug;24(8):1328-34. doi: 10.2337/diacare.24.8.1328.

  PMID: 11473065 RESULT

• Nekkanti S, Wu JM, Hundley AF, Hudson C, Pandya LK, Dieter AA. A randomized trial comparing continence pessary to continence device (Poise Impressa(R)) for stress incontinence. Int Urogynecol J. 2022 Apr;33(4):861-868. doi: 10.1007/s00192-021-04967-9. Epub 2021 Sep 9.

  PMID: 34505171 RESULT

• 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 RESULT

• Duenas-Garcia OF, Shapiro RE, Gaccione P. Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2021 Jun 1;27(6):360-364. doi: 10.1097/SPV.0000000000000861.

  PMID: 32453209 RESULT

• 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 RESULT

• 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 RESULT

• Lipp A, Shaw C, Glavind K. Mechanical devices for urinary incontinence in women. Cochrane Database Syst Rev. 2014 Dec 17;2014(12):CD001756. doi: 10.1002/14651858.CD001756.pub6.

  PMID: 25517397 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Model Details: Prior to randomization participants will be sent the Poise Impressa sizing kit via mail. They will then be asked what size of device works best for them based on the sizing kit. After this information is obtained they will then be sent both Revive and correct size of Poise Impressa. They will be randomized at this time regarding which device they will start with. If participants are menstruating, they will be asked to start this study after their last day of bleeding as this study will last approximately 20 days. They will then begin using the device they were randomized to use first for 7 days. There will be a three day wash out period and them they will use the remaining device for 7 days.

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: June 30, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)