In this critical review, we explore the study design, strengths and limitations of the paper: "Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial." The paper reports 24 month follow-up data of the landmark ROSETTA trial. This multi-centre, open-labelled parallel randomised trial allocated females 1:1 to receive Sacral Neuromodulation (SNM) or OnabotulinumtoxinA(BTX) 200 units (U). The primary outcome was change in mean daily urinary urgency incontinence episodes (UUIE) over 24 months. The study did not demonstrate a difference between treatments (-3.88 vs. -3.50 episodes per day), however women treated with BTX were more satisfied; but reported higher rates of UTI. The two treatments provide comparable third-line treatment options for patients with refractory urgency urinary incontinence.
Keyphrases
- urinary incontinence
- urinary tract
- study protocol
- clinical trial
- polycystic ovary syndrome
- minimally invasive
- physical activity
- electronic health record
- emergency department
- randomized controlled trial
- big data
- type diabetes
- machine learning
- skeletal muscle
- metabolic syndrome
- artificial intelligence
- cervical cancer screening
- urinary tract infection
- newly diagnosed
- deep learning