This double-blind randomized controlled trial seeks to find a better treatment for women with mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary incontinence better than sling surgery alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.
Saline will be injected into the bladder so that investigators are masked to subject randomization.
Northwestern Medicine Integrated Pelvic Health Clinic
Chicago, Illinois, United States
Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms
Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome
Time frame: 3 months after surgery
Incontinence Episode Frequency
Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject
Time frame: 3 months after surgery
Urinary Incontinence Symptoms and Quality of Life
Urinary incontinence symptoms and quality of life will be assessed by a satisfaction survey completed by the subject. The scale is 0-100. and higher scores indicate worse outcomes.
Time frame: 3 months after surgery
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