NCT02506309 - 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)

Nambiar A, Cody JD, Jeffery ST
Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2014 Jun 1;(6):CD008709. doi: 10.1002/14651858.CD008709.pub2. Review. Update in: Cochrane Database Syst Rev. 2017 Jul 26;7:CD008709.
Ogah J, Cody DJ, Rogerson L
Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women: a short version Cochrane review. Neurourol Urodyn. 2011 Mar;30(3):284-91. doi: 10.1002/nau.20980. Review.

Prospective Randomized Comparison of the Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence

Clinical trial NCT02506309 - References