NCT02456441 - 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)

Banakhar MA, Al-Shaiji TF, Hassouna MM
Pathophysiology of overactive bladder. Int Urogynecol J. 2012 Aug;23(8):975-82. doi: 10.1007/s00192-012-1682-6. Epub 2012 Feb 7. Review.
Ben-Dror I, Weissman A, Leurer MK, Eldor-Itskovitz J, Lowenstein L
Alterations of heart rate variability in women with overactive bladder syndrome. Int Urogynecol J. 2012 Aug;23(8):1081-6. doi: 10.1007/s00192-012-1738-7. Epub 2012 Apr 11.
Coyne KS, Zyczynski T, Margolis MK, Elinoff V, Roberts RG
Validation of an overactive bladder awareness tool for use in primary care settings. Adv Ther. 2005 Jul-Aug;22(4):381-94.
de Groat WC
Integrative control of the lower urinary tract: preclinical perspective. Br J Pharmacol. 2006 Feb;147 Suppl 2:S25-40. Review.
Fall M, Lindström S
Electrical stimulation. A physiologic approach to the treatment of urinary incontinence. Urol Clin North Am. 1991 May;18(2):393-407. Review.
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society
An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798. Review.
Rosier PF, Hosker GL, Szabó L, Capewell A, Gajewski JB, Sand PK; International Consultation on Incontinence 2008 Committee on Dynamic Testing
Executive Summary: The International Consultation on Incontinence 2008--Committee on: "Dynamic Testing"; for urinary or fecal incontinence. Part 3: Anorectal physiology studies. Neurourol Urodyn. 2010;29(1):153-8. doi: 10.1002/nau.20762. Review.

The Effects of Transcutaneous Tibial Nerve Stimulation in Sympathetic and Parasympathetic System in Women With Overactive Bladder: Randomized Clinical Trial

Details for clinical trial NCT02456441

Clinical trial NCT02456441 - References