Clinical trial NCT03174431: 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
Overall status: COMPLETED
Phase: NA
Conditions: Female Stress Incontinence
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2017-06-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment Success
timeFrame: 4 weeks
Secondary outcomes:
measure: Validated Questionnaires
timeFrame: 4 weeks
measure: Satisfaction With Device
timeFrame: 4 weeks
measure: Adverse Events
timeFrame: 4 weeks
measure: 6 Month Follow up
timeFrame: 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References:
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