BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence

Summary

This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.

Timeline

Start

2017-10-04

Primary completion

2020-07-21

Completion

2020-07-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Stage 2: Placebo + Hydrogel Admixture vs Stage 2: BOTOX® 300U + Hydrogel Admixture; p = 0.0041 NCT03320850 ↗

registry Least Squares Mean Difference 1.83 (95% CI 0.59 to 3.08); ANCOVA NCT03320850 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	100 iu	Other
Subject	Botulinum toxin type A	Protein / enzyme biologic	300 iu	Other
Subject	Botulinum toxin type A	Protein / enzyme biologic	400 iu	Other
Subject	Botulinum toxin type A	Protein / enzyme biologic	500 iu	Other

Indications