NCT02428881 - 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)

Dasgupta R, Wiseman OJ, Kitchen N, Fowler CJ
Long-term results of sacral neuromodulation for women with urinary retention. BJU Int. 2004 Aug;94(3):335-7.
Dykstra DD, Sidi AA, Scott AB, Pagel JM, Goldish GD
Effects of botulinum A toxin on detrusor-sphincter dyssynergia in spinal cord injury patients. J Urol. 1988 May;139(5):919-22.
Swinn MJ, Wiseman OJ, Lowe E, Fowler CJ
The cause and natural history of isolated urinary retention in young women. J Urol. 2002 Jan;167(1):151-6. Erratum in: J Urol 2002 Apr;167(4):1805.

Open Label Pilot Study to Treat Women With Chronic Urinary Retention or Voiding Dysfunction Due to a Primary Disorder of Sphincter Relaxation (Fowler's Syndrome) With Outpatient Urethral Injections of Botulinum Toxin A (BoNT-A)

Details for clinical trial NCT02428881

Clinical trial NCT02428881 - References