Safety and Efficacy of Trospium Chloride and Solifenacin in Stroke-induced Neurogenic Lower Urinary Tract Dysfunction

Hajebrahimi S1, Salehi-Pourmehr H1, Pourmohammad A1, Charalampos K2, Samarinas M3, Morsali S1, Mostafaei H4, Farhoudi M1, Rahnama'i M5, Beheshti R1

Research Type

Clinical

Abstract Category

Neurourology

Abstract 455
Open Discussion ePosters
Scientific Open Discussion Session 102
Wednesday 23rd October 2024
12:40 - 12:45 (ePoster Station 5)
Exhibition Hall
Overactive Bladder Rehabilitation Clinical Trial
1. Tabriz University of Medical Sciences, 2. National Rehabilitation Center, Athens, Greece, 3. General Hospital of Larissa, Tsakalof 1 Str, 41221, Larissa, Greece., 4. Medical University of Vienna, 1090 Vienna, Austria, 5. St. Elisabeth-Tweesteden Hospital, 5022 Tilburg, The Netherlands
Presenter
Links

Poster

Abstract

Hypothesis / aims of study
The complexities of stroke-related complications are diverse. After experiencing a stroke, the neural pathways responsible for urination can be compromised. Lower urinary tract symptoms are highly prevalent, affecting up to 94% of stroke patients. Treatment for neurogenic lower urinary tract dysfunction (NLUTD) focuses on safeguarding the upper urinary tract from harm while preserving urinary continence. The effectiveness of various oral or intravesical medications in managing detrusor overactivity and enhancing bladder compliance in NLUTD has been examined. Oral antimuscarinic agents have been a cornerstone of pharmacotherapy for addressing symptoms of overactive bladder in NLUTD for many years. NLUTD is a complex condition with significant challenges in urology. Our study seeks to assess the effectiveness of a 4-week treatment with Solifenacin and Trospium chloride on NLUTD, as well as their safety and impact on the quality of life of patients with stroke.
Study design, materials and methods
This study, conducted on 206 stroke patients, was a triple-blind, multi-center, randomized controlled trial that received approval from the Ethical Committee and was registered on IRCT (IRCT20160606028304N2). Patient recruitment took place at two locations: the Stroke Registry Center of Imam Reza Hospital at Tabriz University of Medical Sciences and the Rehabilitation Center of Athens-Greece Hospital.
In terms of participants and design, individuals aged 18 and above who had experienced a stroke with a clinical diagnosis according to the World Health Organization (1989), confirmed by computed tomography or magnetic resonance imaging, assessed by a neurologist, and demonstrated normal cognitive function (MMSE > 25) were eligible to participate. Eligible participants also had to exhibit lower urinary tract symptoms (LUTS) based on the ICIQ-OAB or NBSS questionnaire. Exclusion criteria included evidence of brainstem involvement or bilateral symptoms, psychiatric disorders, history of LUTS surgery, pelvic or trauma surgery, severe neurological diseases, prostate cancer, inability to participate in the study, abnormal liver function, severe constipation, glaucoma, and allergies to anticholinergic agents. Participants were randomly assigned to receive oral Solifenacin, Trospium chloride, or a placebo.
Results
The research commenced in July 2021 and concluded follow-up assessments by December 2022. Within this randomized controlled trial, 206 patients were randomly assigned to three groups: 69 in the Solifenacin group, 74 in the Trospium chloride group, and 63 in the placebo group. All participants were successfully followed up and completed the trial.
The majority of participants were male, with an average age of 67.3, mostly with ischemic stroke. There were no significant differences in urinary symptom progression post-stroke among the groups. Symptoms improved in all groups based on the NBSS questionnaire post-treatment compared to baseline (P<0.05). Scores for ICIQ-OAB, ICIQ-LUTS-QOL, and bothersome symptoms significantly decreased post-treatment compared to baseline (P<0.001). Both Trospium chloride and Solifenacin were effective in alleviating symptoms compared to placebo based on NBSS and ICIQ scores. Solifenacin showed superiority over Trospium chloride in certain aspects and had fewer side effects.
Interpretation of results
Solifenacin and Trospium chloride are effective treatments for OAB in stroke patients with NLUTD, with Solifenacin being recommended due to its superior therapeutic response and lower side effect profile.
Concluding message
Solifenacin and Trospium chloride are effective treatments for OAB in stroke patients with NLUTD, with Solifenacin being recommended due to its superior therapeutic response and lower side effect profile.
Figure 1
References
  1. Sakakibara R. Lower urinary tract dysfunction in patients with brain lesions. Handbook of clinical neurology. 2015;130:269-287
  2. ibaek S, Gard G, Klarskov P, Iversen HK, Dehlendorff C, Jensen R. Prevalence of lower urinary tract symptoms (luts) in stroke patients: A cross-sectional, clinical survey. Neurourol Urodyn. 2008;27:763-771
  3. Chapple CR, Rechberger T, Al-Shukri S, Meffan P, Everaert K, Huang M, et al. Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder. BJU Int. 2004;93:303-310
Disclosures
Funding None Clinical Trial Yes Registration Number IRCT20160606028304N2 RCT Yes Subjects Human Ethics Committee IR.TBZMED.REC.1399.095 Helsinki Yes Informed Consent Yes
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