NCT02022722 - 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)

Jarvis SK, Abbott JA, Lenart MB, Steensma A, Vancaillie TG
Pilot study of botulinum toxin type A in the treatment of chronic pelvic pain associated with spasm of the levator ani muscles. Aust N Z J Obstet Gynaecol. 2004 Feb;44(1):46-50.
Langford CF, Udvari Nagy S, Ghoniem GM
Levator ani trigger point injections: An underutilized treatment for chronic pelvic pain. Neurourol Urodyn. 2007;26(1):59-62.
Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF
Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7.
Rao SS, Paulson J, Mata M, Zimmerman B
Clinical trial: effects of botulinum toxin on Levator ani syndrome--a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2009 May 1;29(9):985-91. doi: 10.1111/j.1365-2036.2009.03964.x. Epub 2009 Feb 13.

Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections

Clinical trial NCT02022722 - References