Reduced-Dose OnabotulinumtoxinA for Urgency Incontinence in Older Women: Methods

Area of Science:

• Gerontology
• Urology
• Pharmacology

Background:

• Older women experience high rates of overactive bladder (OAB) and urgency urinary incontinence (UUI).
• Existing treatments for OAB/UUI in this population present unique challenges.
• There is a need to optimize OAB/UUI care for older women.

Purpose of the Study:

• To design and conduct a randomized controlled noninferiority trial comparing low-dose (50 unit) versus standard-dose (100 unit) onabotulinumtoxinA (OnabotA).
• To evaluate OnabotA efficacy for OAB symptoms in women aged 70 years and older with UUI.

Main Methods:

• A randomized controlled noninferiority trial involving women aged 70+ with UUI.
• Primary outcome: change in quality of life (QOL) assessed by OABq-SF at 3 months.
• Secondary outcomes: symptom bother, satisfaction, depression, adverse events, and cost analysis over 12 months.

Main Results:

• A total of 376 participants are targeted for randomization.
• The study requires 278 participants to detect noninferiority with 90% power.
• Inclusion criteria focus on women aged 70+ with urgency or mixed urinary incontinence.

Conclusions:

• This trial will provide crucial data on the efficacy and safety of reduced-dose OnabotA for OAB/UUI in older women.
• Findings will inform treatment decisions regarding symptom-specific and health-related QOL outcomes.
• The study will contribute to understanding patient-reported outcomes and adverse events.