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Fesoterodine treatment of pediatric patients with neurogenic detrusor overactivity: A 24-week, randomized, open-label, phase 3 study.

Author: CrookTim J, DarekarAmanda, JonesPhilip, KittaTakeya, LindsayMonica, MalhotraBimal, MallenSharon, NietoAlejandra, ShahinMohamed H

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.

Overview

Fesoterodine is safe and effective in treating neurogenic detrusor overactivity (NDO) in children aged 6 to 18 years. This open-label phase 3 study in 2 pediatric cohorts showed fesoterodine 4 and 8 mg and fesoterodine 2 and 4 mg BIC treatment resulted in significant increases from baseline in maximum cystometric bladder capacity (MCC) at Week 12. Fesoterodine 4 and 8 mg and fesoterodine 4 mg BIC led to improvements in secondary efficacy endpoints. No detrimental effects on visual accommodation or acuity, or on cognitive function or behavior were observed.
Paper Details　
Original Abstract of the Article :
BACKGROUND: Neurogenic detrusor overactivity (NDO) can damage the upper urinary tract leading to chronic renal impairment. Antimuscarinic therapy is used to improve urinary incontinence and protect the upper urinary tract in patients with NDO. OBJECTIVE: This study investigated safety and efficacy ...See full text at original site
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引用元：
https://doi.org/10.1016/j.jpurol.2022.11.020

データ提供：米国国立医学図書館（NLM）

Fesoterodine: A New Hope for Pediatric Detrusor Overactivity

Neurogenic detrusor overactivity (NDO), a condition affecting bladder control, can lead to significant health complications in children. This study investigates the safety and efficacy of fesoterodine, a muscarinic receptor antagonist, in treating pediatric patients with NDO. The researchers conducted a randomized, open-label, phase 3 study involving two pediatric cohorts, examining the effects of fesoterodine on bladder function and safety.

Fesoterodine: A Promising Treatment Option

The study found that fesoterodine treatment resulted in significant improvements in bladder capacity and other key measures of bladder function in both cohorts. The medication was well tolerated, with the most common side effects being gastrointestinal in nature. No significant adverse effects on vision, cognition, or behavior were observed. These findings suggest that fesoterodine may be a valuable treatment option for pediatric patients with NDO, offering potential benefits in improving bladder control and reducing the risk of complications.

A New Frontier in Pediatric Care: Expanding Treatment Options

The study provides valuable insights into the potential of fesoterodine for treating NDO in children. It expands the range of treatment options for this challenging condition and offers hope for improving the quality of life for children with NDO. Further research is needed to confirm the long-term benefits and safety of fesoterodine in this population.

Dr. Camel's Conclusion

This study, like a gentle breeze bringing relief from the desert heat, offers a promising new treatment option for children with NDO. Fesoterodine, a medication previously used for adults with overactive bladder, appears to be safe and effective for treating this condition in children. This research is a testament to the ongoing efforts to improve pediatric care and offer hope for better management of challenging conditions.

Date :
  1. Date Completed 2023-03-28
  2. Date Revised 2023-03-29
Further Info :

Pubmed ID

36504158

DOI: Digital Object Identifier

10.1016/j.jpurol.2022.11.020

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SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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