NCT02667002 - 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)

Jäger W, Mirenska O, Brügge S
Surgical treatment of mixed and urge urinary incontinence in women. Gynecol Obstet Invest. 2012;74(2):157-64. Epub 2012 Aug 9.
Joukhadar R, Meyberg-Solomayer G, Hamza A, Radosa J, Bader W, Barski D, Ismaeel F, Schneider G, Solomayer E, Baum S
A Novel Operative Procedure for Pelvic Organ Prolapse Utilizing a MRI-Visible Mesh Implant: Safety and Outcome of Modified Laparoscopic Bi
Sze EH, Meranus J, Kohli N, Miklos JR, Karram MM
Vaginal configuration on MRI after abdominal sacrocolpopexy and sacrospinous ligament suspension. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):375-9; discussion 379-80.

Randomized Single Blind Controlled Trial of Comparison of Anatomic and Sexual Outcomes Between Conventional and Bilateral Sacral Hysteropexy

Clinical trial NCT02667002 - References