Efficacy of Fesoterodine Fumarate in Neurogenic Detrusor Overactivity Due to Spinal Cord Lesion or Multiple Sclerosis: A Prospective Study - European Medical Journal
×

Browse

Efficacy of Fesoterodine Fumarate in Neurogenic Detrusor Overactivity Due to Spinal Cord Lesion or Multiple Sclerosis: A Prospective Study

|
3 Mins
Urology featured Image
Authors:
*Charalampos Konstantinidis,1 Zisis Kratiras,1 Moira Tzitzika,1 Michael Samarinas,2 Charalampos Thomas,3 Konstantinos Giannitsas,4 Anastasios Athanasopoulos4
Disclosure:

The authors have declared no conflicts of interest.

Acknowledgements:

The authors would like to thank Archontia Nikolia and the Head Nurse of the Outpatient Department, National Rehabilitation Center, Athens, Greece, who played an important role to inform patients for the study and obtain the signed consent form.

Citation
EMJ Urol. ;9[1]:40-41. Abstract Review No. AR4.

Each article is made available under the terms of the Creative Commons Attribution-Non Commercial 4.0 License.

Receive our free quarterly newsletters and your choice of journal publication alerts, straight to your inbox.

Join our mailing list

BACKGROUND AND AIMS

Antimuscarinic drugs are the first-line choice in the treatment of patients with neurogenic detrusor overactivity (NDO), even if the relative literature is still limited.1,2 Fesoterodine fumarate is the newest antimuscarinic drug. No study has been yet published about the use of fesoterodine fumarate in patients affected by neurogenic lower urinary tract dysfunction. The aim of the authors’ study was to determine the efficacy of fesoterodine fumarate for the treatment of patients with NDO due to multiple sclerosis (MS) or spinal cord lesion (SCL).

MATERIALS AND METHODS

The study was designed as an open-label prospective interventional trial without a control group. Eligible subjects for enrolment were considered patients between 18 and 80 years of age affected by NDO, confirmed by urodynamic studies (UDS), secondary to MS or SCL of at least 6 months before their enrolment. All participants provided informed consent and the study had the approval of the scientific and ethics committee of the National Rehabilitation Center, Athens, Greece. It was considered unethical to create a placebo (or a non-therapy) control group as the increased detrusor pressure might harm the unit under test of the patients. On the other hand, previous studies on other antimuscarinics proved that the placebo effect is rather ’limited’ in such a cohort of neurological patients.

A 2-week wash-out period was requested prior to enrolment for patients under drug medication for the treatment of NDO. All patients underwent a first confirmatory baseline UDS and fulfilled the SF-Qualiveen as a quality of life (QoL) questionnaire.3-5 Afterwards, all subjects received a treatment of 8 mg fesoterodine daily for 3 months. At the completion of this period, they repeated the UDS and SF-Qualiveen. Each UDS was performed with the same equipment in the same environment from the same clinician, unaware of the study hypothesis, according to the International Classification for Standards’ (ICS) urodynamic practices and terms.6 The primary endpoint of the study was the change from baseline to end of treatment in maximum detrusor pressure (Pdetmax) during the filling phase of the UDS, and whether the use of fesoterodine fumarate would decrease it. Secondary endpoints included changes from baseline to end of treatment in bladder capacity and compliance. By analysing the questionnaires pre- and post-treatment, patient QoL was evaluated. Statistical analysis was performed using SPSS® Statistics 26 (IBM, Endicott, New York, USA).

RESULTS

One hundred and thirty-seven patients were recruited and 124 of them, 68 males and 56 females, completed the study. Of the included patients, 95 had SCL (60 paraplegia and 35 tetraplegia) and 29 had MS. The urodynamic parameters Pdetmax, bladder capacity, and compliance were estimated for the whole group before and after treatment and were proved to be statistically different when compared to the baseline (p<0.001 for all variables), according to the Wilcoxon test for a non-parametric sample. Changes in urodynamics parameters were also significant in each of the paraplegic, tetraplegic and MS groups (p<0.001) (Table 1). According to all the domains of SF-Qualiveen, QoL also improved. There was a significant difference in SF-Qualiveen score after treatment with fesoterodine in all patients, independently of the diagnosis.

Table 1 Variance of the urodynamic variables after treatment with fesoterodine fumarate

Table 1: Variance of the urodynamic variables after treatment with fesoterodine fumarate.
Pdetmax: maximum detrusor pressure; POST: after treatment; PRE: before treatment.

CONCLUSIONS

Fesoterodine fumarate is an efficacious drug in patients with SCL and MS, as it significantly decreases the detrusor pressure, increases the bladder capacity and compliance, and improves the QoL.

References
European Association of Urology. Blok B et al. EAU Guidelines on Neuro-Urology. 2020. The Netherlands. Available at: http://www.uroweb.org/guideline/neuro-urology/. Last accessed: 9 August 2021. Madhuvrata et al. Anticholinergic drugs for adult neurogenic detrusor overactivity: a systematic review and meta-analysis. Eur Urol. 2012;62(5):816-30. Konstantinidis C et al. Translation and cultural adaptation of SF Qualiveen questionnaire in greek. Eur J Phys Rehabil Med. 2020;DOI:10.23736/S1973-9087.20.06558-2. Costa P et al. Quality of life in spinal cord injury patients with urinary difficulties. Development and validation of Qualiveen. Eur Urol. 2001;39(1):107-13. Bonniaud V et al. Measuring quality of life in multiple sclerosis patients with urinary disorders using the Qualiveen questionnaire. Arch Phys Med Rehabil. 2004;85(8):1317-23. Rosier PFWM et al. International continence society good urodynamic practices and terms 2016: urodynamics, uroflowmetry, cystometry, and pressure-flow study. Neurourol Urodyn. 2017;36(5):1243-60.