NCT04184752 - 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)

Choi YS, Kim JC, Lee KS, Seo JT, Kim HJ, Yoo TK, Lee JB, Choo MS, Lee JG, Lee JY
Analysis of female voiding dysfunction: a prospective, multi-center study. Int Urol Nephrol. 2013 Aug;45(4):989-94. doi: 10.1007/s11255-013-0475-2. Epub 2013 May 31.
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN
An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic
Hsiao SM, Lin HH, Kuo HC
Videourodynamic Studies of Women with Voiding Dysfunction. Sci Rep. 2017 Jul 28;7(1):6845. doi: 10.1038/s41598-017-07163-2.
Karmakar D, Sharma JB
Current concepts in voiding dysfunction and dysfunctional voiding: A review from a urogynaecologist's perspective. J Midlife Health. 2014 Jul;5(3):104-10. doi: 10.4103/0976-7800.141185. Review. Retraction in: J Midlife Health. 2018
Lukacz ES, DuHamel E, Menefee SA, Luber KM
Elevated postvoid residual in women with pelvic floor disorders: prevalence and associated risk factors. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Apr;18(4):397-400. Epub 2006 Jun 28.
Milleman M, Langenstroer P, Guralnick ML
Post-void residual urine volume in women with overactive bladder symptoms. J Urol. 2004 Nov;172(5 Pt 1):1911-4.
Robinson D, Staskin D, Laterza RM, Koelbl H
Defining female voiding dysfunction: ICI-RS 2011. Neurourol Urodyn. 2012 Mar;31(3):313-6. doi: 10.1002/nau.22213. Epub 2012 Mar 13. Review.

Urodynamically Age-specific Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Female Voiding Dysfunction Without Cystocele

Clinical trial NCT04184752 - References