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Role of Protopine and Nuciferine in the Management of Nocturia, Urgency, and Dysuria in Pre- and Postmenopausal Women: A Prospective Pilot Study.
Plotti, Francesco; Silvagni, Adele; Cundari, Gianna Barbara; Ficarola, Fernando; De Cicco Nardone, Carlo; Guzzo, Federica; Fabris, Silvia; Luvero, Daniela; Angioli, Roberto; Terranova, Corrado; Montera, Roberto.
Afiliação
  • Plotti F; Department of Gynecology, Campus Bio-Medico University Hospital Foundation, Rome, Italy.
  • Silvagni A; Department of Gynecology, Campus Bio-Medico University Hospital Foundation, Rome, Italy.
  • Cundari GB; Department of Gynecology, Campus Bio-Medico University Hospital Foundation, Rome, Italy.
  • Ficarola F; Department of Gynecology, Campus Bio-Medico University Hospital Foundation, Rome, Italy.
  • De Cicco Nardone C; Department of Gynecology, Campus Bio-Medico University Hospital Foundation, Rome, Italy.
  • Guzzo F; Department of Gynecology, Campus Bio-Medico University Hospital Foundation, Rome, Italy.
  • Fabris S; National Center for Control and Emergency Against Animal Diseases and Central Crisis Unit - Office III, Directorate-General for Animal Health and Veterinary Drugs, Italian Ministry of Health, Rome, Italy.
  • Luvero D; Medical Statistics and Epidemiology Unit, Campus Bio-Medico University, Rome, Italy.
  • Angioli R; Department of Gynecology, Campus Bio-Medico University Hospital Foundation, Rome, Italy.
  • Terranova C; Department of Gynecology, Campus Bio-Medico University Hospital Foundation, Rome, Italy.
  • Montera R; Department of Gynecology, Campus Bio-Medico University Hospital Foundation, Rome, Italy.
Gynecol Obstet Invest ; 88(1): 47-52, 2023.
Article em En | MEDLINE | ID: mdl-36535262
OBJECTIVES: Nocturia was commonly treated with drugs burdened with high costs and numerous side effects; in fact, more than 70% of patients drop out of long-term treatment. Protopine and nuciferine are two alkaloids that have different effects on the neurotransmitter receptors involved in the regulation mechanism of the onset of urinary stimuli. The aim of the study was to evaluate the efficacy in controlling primarily nocturia and secondarily urgency and dysuria after 3 months of treatment with combination therapy of protopine and nuciferine syrup. DESIGN: This is a prospective cohort study in which all patients were diagnosed with overactive bladder syndrome (OAB) and the presence of the following symptoms: nocturia, urgency, and dysuria. Thirty patients were administered 10 mL/die (16.6 mg of nuciferine, 0.09 mg of protopine) of syrup for 3 months. Patients were evaluated at baseline (T0) with the International Consultation on Incontinence Questionnaire (ICIQ), Visual Analogue Scale (VAS) for the evaluation of dysuria, Patient Perception of Intensity of Urgency Scale (PPIUS) and at 3 months (T1) with the Patients' Global Impression of Change (PGI-C) scale, PPIUS, VAS, and ICIQ. PARTICIPANTS: Women with diagnosis of OAB; the presence of nocturia, urgency, and dysuria symptoms agreeing to undergo treatment and compiling informed consent; and the absence of contraindications to the use of active ingredients were included in the study. SETTING: Patients were recruited at T0 during the visit to the Uro-Gynecology clinic of the University of "Campus Bio-Medico" and visited again 3 months (T1) after the initiation of therapy. METHODS: We explored survey data by descriptive statistics: in particular, continuous values (i.e., ICIQ) have been summarized by mean and standard deviation of discrete ordinal values (i.e., VAS, PPIUS, and bladder diary parameters at T0 and T1) by median, minimum, and maximum reported scores. Where we could assume normality in distribution, assessed by the Shapiro-Wilk test and the evaluation of the QQ plot, we compared the observation of T0 and T1 with the paired Student's t test; otherwise, we tested differences in distribution with the paired Mann-Whitney U test. RESULTS: Thirty patients completed a 3-month therapy. The ICIQ and VAS questionnaires for the assessment of dysuria, both, reported an improvement in dysuria at T1 (p < 0.001). The PPIUS questionnaire reported an improvement in urinary urgency at T1 (p < 0.001). The PGI-C scale in T1 indicated an improvement in symptoms: 93% for nocturia, 70% for urinary urgency, and 63% for dysuria. LIMITATIONS: The weaknesses of this study are the small number of patients; as a pilot study, the study design was not randomized with a placebo and without blinding; and the short follow-up. CONCLUSIONS: Protopine and nuciferine can be an interesting alternative to primarily treat and reduce nocturia episodes, in addition to improving OAB-related urgency and dysuria.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Bexiga Urinária Hiperativa / Noctúria Tipo de estudo: Clinical_trials / Observational_studies Limite: Female / Humans Idioma: En Revista: Gynecol Obstet Invest Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Itália

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Bexiga Urinária Hiperativa / Noctúria Tipo de estudo: Clinical_trials / Observational_studies Limite: Female / Humans Idioma: En Revista: Gynecol Obstet Invest Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Itália