This phase 4 trial aims to evaluate the benefit of combining onabotA (onabotulinumtoxinA, Botox) injections with vaginal sling procedures for mixed urinary incontinence. The main outcome to be investigated is self-reported urinary incontinence. The trial is recruiting in Chicago (Illinois), USA.
Mixed urinary incontinence (UI) involves both stress and urge UI symptoms. Stress UI refers to involuntary urine leakage during exertion, sneezing, coughing, lifting or any other physical activity. Urge UI is the involuntary urine leakage accompanied by a sudden and compelling desire to pass urine.
Mid-urethral vaginal sling procedures are the most common type of surgery used to help control UI. It involves the placement of a thin mesh tape to lift the urethra to its normal position. OnabotA is a muscle paralyzer used for the treatment of urinary urgency. It is injected directly into the bladder muscle, causing it to relax and reduce symptoms of urge UI.
This study will examine whether combining vaginal sling procedures with onabotA injections is more effective at treating mixed UI than vaginal slings alone. Self-reported UI symptoms, frequency of UI episodes, and quality of life will be measured for 3 months after surgery.
Who are they looking for?
This study will recruit about 100 women, who have symptoms of both stress and urge UI (mixed UI). Participants must be planning to undergo a mid-urethral vaginal sling procedure (without simultaneous prolapse surgery). Participants should be willing to learn how to perform an intermittent self catheterization technique (a way to empty the bladder using a clean catheter), used in cases of urinary retention (an inability to pass urine).
Participants cannot take part in the trial if they have a history of recurrent urinary tract infections (3 or more per year). Participants should not have a neuromuscular disease known to affect the lower urinary tract. Previous treatment with onabotA or incontinence surgery is not permitted. Any use of anticholinergic medication (such as oxybutynin [Ditropan], or tolterodine [Detrol]) must be discontinued for at least 2 months. Participants must not be pregnant.
How will it work
Participants will be randomly assigned to either receive onabotA or placebo (control drug with no active effect) at the time of vaginal sling surgery. 100 units of onabotA will be administered by injection into the detrusor (large muscle of the bladder). Participants in the placebo group will have 100 units of saline (salt water solution) injected.
A questionnaire will assess mixed UI symptoms 3 months after treatment. A self-report 3-day urinary diary will record UI episode frequency. UI symptoms and quality of life will be assessed by a satisfaction survey 3 month after surgery.