Placebo and Hydrogel admixture

This refers to the placebo control arm used in the Phase 2 APOLLO clinical trial (NCT02204020), which evaluated an investigational intravesical delivery system for onabotulinumtoxinA (BOTOX). Developed by Allergan (now AbbVie) in collaboration with UroGen Pharma, this placebo consists of the **RTGel** reverse-thermal hydrogel without the active neurotoxin. RTGel is a thermosensitive polymer technology that remains in a liquid state at cold temperatures and converts into a gel at body temperature. In the trial, the hydrogel was administered via intravesical instillation into the bladder, where it was intended to increase the residence time of the drug and allow for non-invasive delivery without the need for traditional intradetrusor injections. The trial, which targeted patients with overactive bladder and urinary incontinence, was terminated after failing to meet its primary efficacy endpoint, as the active treatment arms did not show a significant improvement over this placebo control.

Other names

RTGel (placebo)Hydrogel admixturePlacebo + hydrogel-Allergan-overactive bladder-urinary incontinence