RESUMO
INTRODUCTION: BCG and MMC shortage and Covid-19 pandemic, more recently, limit accessibility to maintenance regimen in intravesical prophylaxis against recurrence of non-muscle invasive bladder cancer (NMIBC). Ellagic acid (EA) and Annona muricata (AM) exert antitumor activity against different human tumours. An observational prospective study on the prophylactic effect of oral administration of EA+AM in patients avoiding maintenance regimen is presented. MATERIALS AND METHODS: Patients affected by NMIBC and not undergoing maintenance after a 6-week course of intravesical prophylaxis with MMC or BCG were entered. Tis and very high-risk tumours were excluded. After informed consent, the patients were subdivided in relation to the oral assumption or not of EA (100 mg) plus AM (100 mg), daily for 6 months. All patients were submitted to 3-month cytology and cystoscopy. RESULTS: 162 (90%) of 180 entered patients are evaluable, 90 and 72 receiving or not EA+AM. No difference emerged in patients' characteristics between the two groups. BCG was given in 86 (54%) and chemotherapy in 74 (46%) patients. The recurrence free rate at 3, 6 and 12 months in patients assuming or not EA was 96.5% versus 84.6% (p = 0.003), 85.4% versus 64.8% (p = 0.005) and 74.2% versus 60.6% (p = 0.246), respectively. The recurrence free survival at 12 months in patients assuming or not EA was 63.0% versus 34.5% (p < 0.0001). DISCUSSION AND CONCLUSIONS: Our study suffers several limits: not randomized trial although prospective, limited number of patients and short follow-up, nevertheless it shows the prophylactic effect of oral EA+AM in absence of maintenance after intravesical chemotherapy or immunotherapy induction.
Assuntos
Annona , COVID-19 , Neoplasias da Bexiga Urinária , Adjuvantes Imunológicos , Administração Intravesical , Administração Oral , Vacina BCG , Ácido Elágico/uso terapêutico , Humanos , Invasividade Neoplásica , Recidiva Local de Neoplasia/prevenção & controle , Pandemias , Estudos Prospectivos , SARS-CoV-2 , Neoplasias da Bexiga Urinária/tratamento farmacológicoRESUMO
OBJECTIVE: To investigate the physiopathology of ejaculatory disorders (EjD) and discriminate between retrograde ejaculation (REj) and anejaculation (AEj) induced by α1A-blockers, through the association between the mean postorgasm seminal vesicle volume and the presence of sperm in midstream urine, in patients with moderate-to-severe lower urinary tract symptoms (LUTS) secondary to benign prostatic enlargement. MATERIALS AND METHODS: Therapy-naïve male patients with LUTS and without previous EjD were treated with α1A-blockers. Pre- and post-treatment EjD were investigated through question 4 of the 4-item Male Sexual Function questionnaire and the Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF). After 12 weeks, postorgasm urine was collected for sperm count and seminal vesicle volume was calculated through transrectal ultrasound. RESULTS: All 42 patients reported with EjD after treatment with α1A-blockers: 4-item Male Sexual Function questionnaire and MSHQ-EjD-SF Q4 scores were significantly higher (P <.001) and MSHQ-EjD-SF Q1-3 score was significantly lower (P <.001) than before. Postorgasm seminal vesicle volume was significantly higher in patients with postorgasm sperm-negative urine (AEj), and lower in patients with postorgasm sperm-positive urine (REj; P <.001). CONCLUSION: We clearly demonstrated an association between the presence of sperm in the midstream urine and seminal vesicle volume after orgasm, strongly confirming and differentiating the hypothesis of a dual etiology for EjD (REj vs AEj) secondary to α1A-blockers therapy for LUTS.