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Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence

CHU de Quebec-Universite Laval · 2018
ClinicalTrials.gov · Datasets · License: Public Domain · 2018
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femalenapatient-satisfactionstresssurveys-and-questionnairestreatment-outcomeurinary-incontinence
Stress urinary incontinence (SUI) is a highly prevalent condition of involuntary urine leakage associated with coughing, sneezing or exertion. Midurethral slings (MUS) are a safe and efficacious surgical option to treat SUI and is considered the best treatment by recognized organizations. Nevertheless, it remains a surgical intervention exposing patients to risks, possible recurrence and is not recommended to women planning to have more children. Incontinence pessaries offer an alternative to surgery with a similar mechanism of action as MUS. However, there is a paucity of literature on the outcomes of incontinence pessary treatment of SUI, with only two prospective studies have been published on the Uresta pessary and one australian case-series on Contiform pessary. The objective of the study is to evaluate the effectiveness of the self-positioning Contiform intravaginal pessary used as a conservative method to address stress urinary incontinence in women in order to provide Canadian real-world data. The 3-month efficacy, adverse events and global patient satisfaction (including comfort and ease of insertion) will be assessed. It is hypothesized that the Contiform device will be well tolerated by 60-70% of patients, with no serious adverse events. It will cure SUI for about 50% of them.
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