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Posted by on Jun 22, 2018 in Overactive bladder | 0 comments

In a nutshell

This study investigated the safety and effectiveness of onabotulinumtoxinA (Botox) in adults with overactive bladder (OAB) that does not respond to anti-cholinergic treatment. This study concluded that onabotulinumtoxinA injection significantly improved OAB symptoms and health-related quality of life for these patients.

Some background

OAB has can have a significant effect on a person’s quality of life and overall well-being. Anti-cholinergic agents, such as oxybutynin (Oxytrol), are commonly the first medications used for OAB. Unfortunately, poor effectiveness and side effects often limit their benefit. For these patients, alternative treatment options are limited.

OnabotulinumtoxinA is a treatment that paralyzes the bladder muscle. Because it is delivered directly to the bladder via injection, the potential for systemic side effects is reduced. However, this treatment can lead to complications such urine retention.

Methods & findings

This study involved 557 patients with OAB and urinary incontinence (leakage of urine) that was poorly managed by anti-cholinergics. 50.3% of patients received onabotulinumtoxinA injection, and 49.7% of patients received an injection containing a placebo (substance with no active effect). Patients were followed up at 2, 6, and 12 weeks post-treatment. The study period was a total of 24 weeks. 88.9% of treatment group and 87.7% of placebo group completed the study.

At 12 weeks, the average daily frequency of incontinence episodes decreased by 2.65 in treatment group, versus 0.87 in placebo group. From baseline, this corresponded to an average decrease of 47.9% versus 12.5% with active treatment. 57.5% of treated patients, versus 28.9% of placebo patients showed a 50% or more reduction in leakage episodes. 22.9% of treated patients versus 6.5% of placebo patients achieved complete continence (no leakage episodes). Overall, 60.8% of patients receiving Botox reported a positive response to treatment, compared to only 29.2% of patients receiving a placebo injection.

The average number of daily voids (urinations) decreased by 2.15 with active treatment. Urgency episodes decreased by an average of 2.93. Episodes of nocturia (nighttime voids) decreased by 0.45 per night. The amount of urine voided per trip to bathroom increased for treated patients (by 41.1 mL on average). These differences were all statistically significant compared to placebo treatment. 

In a standard questionnaire assessing quality of life, treated patients showed an overall score increase of 21.9 points from baseline, compared to an improvement of only 6.8 points with placebo.

Urinary tract infections (UTIs) were the most commonly reported side effect, occurring in 15.5% of patients receiving treatment. All UTIs were uncomplicated and mild to moderate in severity. Additional side effects occurring more frequently in treated patients included dysuria (12.2%; painful or difficult urination), bacteriuria (5.0%; presence of bacteria in the urine) and urinary retention (5.4%).

The bottom line

This study concluded that onabotulinumtoxinA injection significantly improved OAB symptoms and health-related quality of life for patients who do not respond to anti-cholinergic medications.

The fine print

This study was funded by Allergan, Inc., the manufacturer of onabotulinumtoxinA.

Published By :

Journal of Urology

Date :

Dec 21, 2016

Original Title :

OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial.

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