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A randomized, multicenter, controlled study, comparing efficacy and safety of a new complementary and alternative medicine (CAM) versus Solifenacin Succinate in women with overactive bladder syndrome

Carlo Vecchioli-Scaldazza, Carolina Morosetti, Serena Maruccia, Stefano Casellato, Wilma Rociola, Ester Illiano, Francesco Garofalo
  • Carlo Vecchioli-Scaldazza
    Uroginecology Unit, ASUR n° 2 Jesi (AN), Italy | cascave@alice.it
  • Carolina Morosetti
    Clinical Laboratory Department, ASUR n° 2 Jesi (AN), Italy
  • Serena Maruccia
    Functional Urology Unit, Zucchi Clinical Institutes, Monza, Italy
  • Stefano Casellato
    Functional Urology Unit, Zucchi Clinical Institutes, Monza, Italy
  • Wilma Rociola
    Urology Unit, ASL1, Umbria, Italy
  • Ester Illiano
    Department of Surgical and Biomedical Sciences, Urology and Andrology Clinic, University of Perugia, Italy
  • Francesco Garofalo
    Urology Division, Villa Maria Hospital, Rimini, Italy

Abstract

Introduction: To assess efficacy and tolerability of a new complementary and alternative medicine (CAM) consisting of vitamins (C and D), herbal products (cucurbita maxima, capsicum annum, polygonum capsicatum) and amino acid L-Glutammina, in the treatment of female Overactive Bladder syndrome (OAB). Materials and methods: 90 consecutive women with OAB symptoms were enrolled in this prospective, randomized, controlled study. Women were divided randomly into two groups of 45 patients each. In group A, women received Solifenacin Succinate (SS), 5 mg. once a day for 12 weeks. In group B, women received CAM, 930 mg, twice daily for 12 weeks. Women were assessed with 3-day micturition diary, Patient Perception of Intensity of Urgency Scale (PPIUS), Overactive Bladder questionnaire Short Form (OAB-q SF) and Patient Global Impression of Improvement questionnaire (PGI-I). Results: 8 patients in group A and 1 patient in group B dropped out from therapy because of side effects. A reduction in the number of daily micturitions, nocturia and episodes of urge incontinence was present with both SS and CAM with statistically highly significant differences, but CAM was significantly more effective than SS. PPIUS and OAB-q SF showed improvements with both SS and CAM with a more significant efficacy of CAM. PGI-I, demonstrated improvements in the two groups of patients with a greater satisfaction expressed by patients treated with CAM. Conclusions: the small number of patients does not permit definitive conclusions; however, the results of the research showed the greater effectiveness and tolerability of CAM.

Keywords

Overactive bladder; Solifenacin; Capsaicin; Cucurbita maxima; Capsicum annum; Polygonum cuspidatum; Vitamin D; Vitamin C; Glutamine; Complementary medicine

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Submitted: 2017-09-25 08:34:35
Published: 2017-12-31 00:00:00
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