Objective
The purpose of this study is to evaluate the effect of Intravesical Botulinum toxin injection on the symptoms and urodynamic parameters in pediatric patients with idiopathic overactive bladder (iOAB) refractory to medical treatment.Materials and methods
The study was designed as an open-label uncontrolled therapeutic clinical trial. The eligible patients who underwent Intravesical botulinum toxin injection were evaluated before treatment. The evaluation included a 7-day paper bladder diary to assess OAB symptoms (frequency, urgency urinary incontinence (UUI) and nocturnal enuresis (NE)), filling the Arabic International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI short form), and conducting urodynamic study. The Urodynamic parameters obtained were the maximum filling detrusor pressure, cystometric bladder capacity, and compliance. After 12?weeks of the intravesical injection, the patients were revaluated and the results were compared using paired samples t-test.Results
The study enrolled 75 patients. And of those, statistical analysis was done on 46 patients who did follow the study protocols. The mean age was 8.9?years and male to female ratio was 1:4. There was a statistically significant improvement in overactive bladder symptoms and urodynamic parameters in the patient injected with botulinum toxin with minimal side effects.Conclusion
The evidence in this study would support the safety and efficacy of Intravesical botulinum toxin injection in children with refractory idiopathic OAB with significant improvement of symptoms, quality of life, as well as urodynamic parameters.Type of Study
Open-label uncontrolled therapeutic clinical trial.Level of Evidence
III 相似文献The COVID-19 outbreak has led to the rapid development and administration of the COVID-19 vaccines worldwide. Data about the immunogenicity and adverse effects of the vaccine on patients with systemic autoimmune rheumatic diseases (SARDs) is emerging.
AimTo evaluate Pfizer/BioNTech (BNT162b2) mRNA-based vaccine second-dose immunogenicity and safety, and the relation between them, in patients with SARDs.
MethodsA total of one hundred forty tow adults who received two doses of the BNT162b2 vaccine were included in the study. The SARDs group included Ninety-nine patients and the control group (forty-three participants) comprised a mixture of healthy participants and patients who were seen at the rheumatology clinic for non-SARDs. Anti-SARS-CoV-2 IgG antibodies against the Spike protein were evaluated using a SARS-CoV-2 IgG immunoassay. A level of > 150 AU/mL was considered positive. An adverse effects questionnaire was given to the participants upon their first visit to the clinic after their BNT162b2 vaccination.
ResultsOf the 142 participants, 116 were seropositive (81.7%) and 26 (18.3%) were seronegative. Of the seronegative participants, 96.2% were SARDs patients. The proportion of seropositivity in the SARDs patients treated with any immunosuppressant was significantly lower (69.9%) compared to the control group and SARDs patients not receiving immunosuppressants (96.8%). A significant negative correlation between seronegativity and treatment with rituximab, mycophenolate mofetil (MMF), and prednisone was found in the SARDs group (p = 0.004, 0.044, 0.007 respectively). No fever was observed following the BNT162b2 vaccine in seronegative patients, and the frequency of musculoskeletal adverse effects upon the second dose of the BNT162b2 vaccine was significantly higher in seropositive compared to seronegative patients and in the control group compared to the SARDs patients (p = 0.045, p = 0.02 respectively).
ConclusionA decline in the immunogenicity to the second dose of BNT162b2 mRNA is seen in patients with SARDs, especially in patients treated with rituximab, MMF, and prednisone. Adverse effects of the vaccine including fever and musculoskeletal symptoms might be a signal for the acquisition of immunity in those patients.
Key Points• BNT162b2 mRNA vaccine is less immunogenic in SARDs patients compared to the control group.
• Rituximab, prednisone, and mycophenolate mofetil significantly reduced immunogenicity to the vaccine.
• There is a correlation between immunogenicity and adverse effects of the vaccine.
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