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Completed

NCT Number: NCT03174431

Continence Pessary Versus Disposable Intravaginal Device Trial

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.

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Key information

Conditions

Female Stress Incontinence

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Poise Impressa

Primary outcomes

  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 outcomes

  1. Validated Questionnaires

    Time frame: 4 weeks

    Validated questionnaire scores obtained at baseline and week 4 with all questionnaires having higher scores indicating higher level of bother:

    • Urinary Distress Inventory (UDI-6): 6 questions measuring urinary incontinence symptom bother. Scale: 0-600.
    • Incontinence Impact Questionnaire (IIQ-7): 7 questions measuring functional impact of urinary incontinence. Scale: 0-100.
    • Female Sexual Function Index (FSFI) : 19 items use a 5-point Likert scale (1-5) to assess sexual functioning in women in 6 domains (Desire, arousal, lubrication, orgasm, satisfaction, pain). Sum of each domain is multiplied by a factor ratio (0.6: desire; 0.3: arousal and lubrication; 0.4: orgasm, satisfaction, and pain) to have all domain totals on a comparable scale.

    Score ranges for each domain:

    • Desire: 1.2- 6
    • Arousal, lubrication, orgasm, and pain: 0- 6
    • Satisfaction: 0.8- 6 They are then summed to derive a total FSFI score of 2- 36.

  2. 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 at 4 weeks.

  3. 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)

  4. 6 Month Follow up

    Time frame: 6 months

    6 month intervention use and satisfaction with following questions as yes or no:

    • Still using device
    • Using other SUI treatment ( pessary, physical therapy)
    • Satisfied with treatment

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study title

A Comparison of Continence Pessary to a Disposable Intravaginal Device in the Management of Stress Urinary Incontinence: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Jun 2, 2017
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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