NCT02782364 - 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)

Hornung BR, Mitchell PJ, Carlson GL, Klarskov N, Lose G, Kiff ES
Comparative study of anal acoustic reflectometry and anal manometry in the assessment of faecal incontinence. Br J Surg. 2012 Dec;99(12):1718-24. doi: 10.1002/bjs.8943. Erratum in: Br J Surg. 2013 Jan;100(2):301.
Klarskov N, Saaby ML, Lose G
A faster urethral pressure reflectometry technique for evaluating the squeezing function. Scand J Urol. 2013 Dec;47(6):529-33. doi: 10.3109/21681805.2013.776629. Epub 2013 Mar 19.
Klarskov N
Urethral pressure reflectometry. A method for simultaneous measurements of pressure and cross-sectional area in the female urethra. Dan Med J. 2012 Mar;59(3):B4412.
Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES
Anal acoustic reflectometry: a new reproducible technique providing physiological assessment of anal sphincter function. Dis Colon Rectum. 2011 Sep;54(9):1122-8. doi: 10.1097/DCR.0b013e318223fbcb.
Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES
Viscoelastic assessment of anal canal function using acoustic reflectometry: a clinically useful technique. Dis Colon Rectum. 2012 Feb;55(2):211-7. doi: 10.1097/DCR.0b013e31823b2499.
Saaby ML, Klarskov N, Lose G
Urethral pressure reflectometry before and after tension-free vaginal tape. Neurourol Urodyn. 2012 Nov;31(8):1231-5. doi: 10.1002/nau.22239. Epub 2012 Mar 27.

Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter

Clinical trial NCT02782364 - References