NCT01194999 - 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)

Chapple CR, Fianu-Jonsson A, Indig M, Khullar V, Rosa J, Scarpa RM, Mistry A, Wright DM, Bolodeoku J; STAR study group
Treatment outcomes in the STAR study: a subanalysis of solifenacin 5 mg and tolterodine ER 4 mg. Eur Urol. 2007 Oct;52(4):1195-203. Epub 2007 Jun 6.
Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S
Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8.
Koch YK, Zimmern P
A critical overview of the evidence base for the contemporary surgical management of stress incontinence. Curr Opin Urol. 2008 Jul;18(4):370-6. doi: 10.1097/MOU.0b013e3282fdf8d5. Review.
Toglia MR, Ostergard DR, Appell RA, Andoh M, Fakhoury A, Hussain IF
Solifenacin for overactive bladder: secondary analysis of data from VENUS based on baseline continence status. Int Urogynecol J. 2010 Jul;21(7):847-54. doi: 10.1007/s00192-010-1120-6. Epub 2010 Mar 26.
Toledo LG, Korkes F, Romero FR, Fernandes RC, Oliveira C, Perez MD
Bladder outlet obstruction after pubovaginal fascial sling. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb;20(2):201-5. doi: 10.1007/s00192-008-0759-8. Epub 2008 Nov 12.

Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence

Clinical trial NCT01194999 - References