NYU Langone urologists continue to test promising new treatments to alleviate bothersome urinary conditions in complex patient populations, such as elderly patients with medical comorbidities and patients with Parkinson’s disease. Findings from several recent studies have the potential to significantly improve quality of life for those struggling with overactive bladder (OAB), the urgent and frequent need to pass urine, and nocturia, which is excessive nighttime urination.
Nasal Spray Provides Relief for Nocturia
One published study examined the effectiveness of AV002, a recently approved emulsified vasopressin nasal spray, in treating elderly patients with nocturia due to nocturnal polyuria. Benjamin M. Brucker, MD, associate professor in the Departments of Urology and Obstetrics and Gynecology, director of female pelvic medicine and reconstructive surgery and neurourology, and director of the female pelvic medicine fellowship program, reported results during a late-breaking session of the 2018 meeting of the American Urological Association (AUA) and as part of a team at the International Continence Society 2018 annual meeting in Philadelphia.
Men and women with nocturia awaken multiple times during the night to urinate, interfering with sleep patterns and often triggering associated problems, such as cognitive decline, depression, and a weakened immune system. Although anticholinergics are currently the standard treatment, previous research by Dr. Brucker and his colleagues demonstrated that AV002 acts faster and is more effective.
“The treatment paradigm we’re currently following isn’t very effective; as a medical community, we could be doing a better job with the management of these patients—and now we have the needed insight to effectively and safely get them the deep, restorative sleep they need.”—Benjamin M. Brucker, MD
In this study, Dr. Brucker and colleagues randomized 2 groups of adults aged 65 and older and 75 and older to receive either AV002 (1.66 mcg or 0.83 mcg) or placebo for 12 weeks. To assess the medication’s impact on sleep quality, researchers measured patients’ first uninterrupted sleep period (FUSP), defined as the time from bedtime to first voiding, and the percentage of nights with no more than one nocturic episode. Of note, the patients in both groups had multiple comorbidities and were on several medications (median=7).
The baseline FUSP was 2.4 hours for both dosage groups and placebo. Both ≥65y and ≥75y patients treated with AV002 demonstrated significant improvement in duration of FUSP and percentage of nights with ≤1 nocturic void. For both age groups, the mean first uninterrupted sleep period after treatment was greater than 4 hours for the 1.66mcg group and approximately 4 hours for the 0.83mcg group.
In addition, AV002 had a side-effect profile similar to that of placebo and was associated with a very low rate of hyponatremia, despite this elderly population’s generally higher risk for side effects.
The findings suggest that physicians should consider AV002 as an alternative to anticholinergics in patients who experience two or more nocturic episodes, says Dr. Brucker. Since nocturia is more common in older patients, these robust data give clinicians a new tool to manage this at-risk population, he adds.
Options for Overactive Bladder in Patients with Parkinson’s Disease
Dr. Brucker also led two retrospective studies investigating alternative treatments for OAB in patients with Parkinson’s disease. Patients with overactive bladder often have distressing urinary incontinence. When patients have a neurological basis for their bladder dysfunction, the efficacy of available treatments can be difficult to assess.
To shed light on the efficacy and safety of potential treatments, Dr. Brucker’s team examined two therapies that have been used in OAB patients without Parkinson’s disease; one study investigated mirabegron, a novel Beta adrenoceptor agonist approved for OAB in 2012; the other examined onabotulinum toxin A injections (Botox; Allergan). While both treatments have been shown to be safe and effective for OAB, anticholinergic drugs—which increase the risk of cognitive dysfunction and adverse events—remain the standard of care for patients with Parkinson’s disease due to lack of clinical studies.
In the first study, investigators examined records of 50 Parkinson’s patients who received daily doses of mirabegron between 2012 and 2017. After 6 weeks of treatment, 50 percent of patients experienced improvement, and 11 percent reported complete resolution of their OAB symptoms. The therapy was well tolerated, and median time to discontinuation (17 months) was longer than that observed in other OAB patients.
In the onabotulinum toxin A study, researchers analyzed outcomes for a cohort of Parkinson’s patients who underwent 100U injections between 2010 and 2017. Over a 4-week period, 79.2 percent of patients showed improved symptoms after the initial injection, increasing to 87.5 percent with repeat injection. About 12 percent of patients required clean intermittent catheterization for urinary retention after the first injection.
The study findings were published in Neurourology and Urodynamics and Parkinsonism and Related Disorders, respectively.
Considering their more favorable side-effect profile compared with anticholinergics, both treatments merit further consideration as viable therapies in Parkinson’s patients with OAB, the researchers concluded.
Disclosure: Dr. Brucker is an advisor and speaker for Avadel (maker of AVOO2) as well as a speaker, advisor, and investigator for Allergan (maker of BOTOX®). He is also an investigator for ISPEN (makes medication similar to Botox) and an advisor for Watkins-Conti Products, Inc. (nothing related to these studies).