NCT00913601 - 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)

Jarrett ME, Mowatt G, Glazener CM, Fraser C, Nicholls RJ, Grant AM, Kamm MA
Systematic review of sacral nerve stimulation for faecal incontinence and constipation. Br J Surg. 2004 Dec;91(12):1559-69. Review.
Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP
Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet. 1995 Oct 28;346(8983):1124-7.
Michelsen HB, Buntzen S, Krogh K, Laurberg S
Rectal volume tolerability and anal pressures in patients with fecal incontinence treated with sacral nerve stimulation. Dis Colon Rectum. 2006 Jul;49(7):1039-44.
Rasmussen OØ, Christiansen J
[Sacral nerve stimulation in fecal incontinence]. Ugeskr Laeger. 2002 Aug 12;164(33):3866-8. Danish.
Vaizey CJ, Kamm MA, Turner IC, Nicholls RJ, Woloszko J
Effects of short term sacral nerve stimulation on anal and rectal function in patients with anal incontinence. Gut. 1999 Mar;44(3):407-12.

Treatment of Idiopathic Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Implantation and Stimulation of Permanent Electrodes Bilaterally - a Double-blinded Randomized Cross-over Trial

Details for clinical trial NCT00913601

Clinical trial NCT00913601 - References