NCT06250543 - 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)

Giannantoni A, Gubbiotti M, Rubilotta E, Balzarro M, Antonelli A, Bini V
IncobotulinumtoxinA versus onabotulinumtoxinA intradetrusor injections in patients with neurogenic detrusor overactivity incontinence: a double-blind, randomized, non-inferiority trial. Minerva Urol Nephrol. 2022 Oct;74(5):625-635. doi: 10.23736/S2724-6051.21.04227-2. Epub 2021 Mar 26.
Lange S, Koch M, Lange R, Husslein H, Umek W, Bodner-Adler B
Perioperative Techniques for the Use of Botulinum Toxin in Overactive Bladder: Results of a Multinational Online Survey of Urogynecologists in Germany, Austria, and Switzerland. J Clin Med. 2023 Feb 12;12(4):1462. doi: 10.3390/jcm12041462.

Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA Efficacy and Safety in Women With Overactive Bladder and Urge Urinary Incontinence and the Value of Local Anesthesia for Pain Reduction

Details for clinical trial NCT06250543

Clinical trial NCT06250543 - References