Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ohio State University
With
University of North Carolina, Chapel Hill
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.
Age
21–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Age 21 years or older (based on disposable intravaginal device manufacturing recommendations).
SUI or SUI-predominant mixed incontinence
English-speaking
You may not be 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
Clareo Health | Continence Pessary Versus Disposable Intravaginal Device Trial
