NCT03614611 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Allen WA, Leek H, Izurieta A, Moore KH
Update: the "Contiform" intravaginal device in four sizes for the treatment of stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jun;19(6):757-61. doi: 10.1007/s00192-007-0519-1.
Farrell SA, Baydock S, Amir B, Fanning C
Effectiveness of a new self-positioning pessary for the management of urinary incontinence in women. Am J Obstet Gynecol. 2007 May;196(5):474.e1-8.
Lovatsis D, Best C, Diamond P
Short-term Uresta efficacy (SURE) study: a randomized controlled trial of the Uresta continence device. Int Urogynecol J. 2017 Jan;28(1):147-150. doi: 10.1007/s00192-016-3090-9. Epub 2016 Jul 20.
Wein AJ, Kavoussi LR, Partin AW, Peters C
Campbell-Walsh urology. 11e ed. Philadelphia, Pennsylvania: Elsevier; 2016

Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence: Effectiveness And Patient Acceptability

Clinical trial NCT03614611 - References