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A Prospective Study to Evaluate the Efficacy of Cistiquer in Improving VOL. 66 . N.4 . DICEMBRE 2014 A PROSPECTIVE STUDY TO EVALUATE THE EFFICACY OF CISTIQUER IN IMPROVING LOWER URINARY TRACT SYMPTOMS IN FEMALES WITH URETHRAL SYNDROME Anno: 2014 Lavoro: Mese: December titolo breve: Efficacy of Cistiquer in improving lower urinary tract symptoms Volume: 66 primo autore: PALLESCHI No: 4 pagine: 1-8 Rivista: MINERVA UROLOGICA E NEFROLOGICA Cod Rivista: MINERVA UROL NEFROL MINERVA UROL NEFROL 2014;66:1-8 A prospective study to evaluate the efficacy of Cistiquer in improving lower urinary tract symptoms in females with urethral syndrome G. PALLESCHI 1, A. CARBONE 1, A. RIPOLI 1, L. SILVESTRI 1 V. PETROZZA 2, P. P. ZANELLO 3, A. L. PASTORE 1 Aim. The aim of the study was to compare 1Unit of Urology, Uroresearch Association Cistiquer, a new phytotherapeutic product Department of Sciences and developed for chronic bladder inflammatory Medico‑Surgical Biotechnologies diseases, and intra-vesical administration of Sapienza University of Rome gentamicin plus betametasone, in females I.C.O.T. Hospital, Latina, Italy with urethral syndrome. 2Unit of Pathology, Department of Sciences and Methods. Between september 2013 and may Medico‑Surgical Biotechnologies 2014, 60 women with urethral syndrome and Sapienza University of Rome trigonitis were incuded in this study. Patients I.C.O.T. Hospital, Latina, Italy 3 were randomly assigned to treatment with Microbiology and Virology intra-vesical administration of betametasone Deakos Scientific Consultant 8 mg plus gentamicin 80 mg (group A), and oral administration of Cistiquer (group B) for 7 weeks. Before and after the therapeutic protocol, symptoms were assessed by three betametasone. However, treatment adherence days voiding diary, the overactive bladder resulted higher for patients treated by oral questionnaire short form and a ten points therapy and rate of adverse events resulted visual analogic scale adopted to assess the higher for those submitted to endovesical micturition discomfort. Histologic findings treatment. were assessed by the examination of speci- Key words: Lower urinary tract symptoms - Ure- mens obtained by cold bladder biopsies of thral syndrome. the bladder trigone at baseline in all the sub- jects. Results. The two groups had significant and rethral syndrome is an ill-understood comparable symptoms improvement. How- ever, the score obtained from the visual ana- Udisease affecting females and respon- logic scale decreased significantly only in the sible for lower urinary tract symptoms group submitted to oral therapy. Further- (LUTS), as urinary frequency, urinary ur- more, in the group treated with endovesical gency, burning micturition, hematuria, and approach, higher drop out rate and higher pelvic pain associated with negative urine incidence of urinary infection were observed. 1 Conclusion. Patients with urethral syndrome cultures. Cystoscopic examination of indi- and trigonitis improved symptoms either viduals suffering from urethral syndrome with oral therapy with Cistiquer and with in- reveals an inflammatory status of the blad- tra-vesical administration of gentamicin plus der neck and trigone, described as trigoni- tis, whose histologic pattern reveals many Corresponding author: A.L. Pastore, MD, Phd, Urology layers of stratified squamous epithelium.2 Unit, Department of Medico-Surgical Sciences and Biotech- nologies, ICOT, Sapienza University of Rome, corso della To cure urethral syndrome, therapies today Repubblica 79, Latina, Italy. E-mail: [email protected] available are symptomatic but most of them Vol. 66 - No. 4 MINERVA UROLOGICA E NEFROLOGICA 1 PALLESCHI Efficacy OF CISTIqUER IN improving lowER URINARy tract Symptoms are not effective and do not contribute to degenerate nucleus.7 Similar findings have significantly improve quality of life of pa- been reported by our pathologists in pa- tients. This is also the consequence of the tients enrolled in this protocol. These al- fact that urethral syndrome has had several terations are usually not found in the lateral sobriquets, which have led to much confu- wall of the bladder, as clearly showed by sion over its existence and the useful op- Pacchioni et al., who showed also clear cor- tions in the care of the afflicted patients.3 respondence between the presence of ster- Urethral syndrome is refractory to antibiosis oid receptors at the squamous metaplasia of and patients often do not respond to oral the trigonum speculating about a possible administration of conventional therapy, endocrine pathogenesis of trigonitis.8 This represented by steroidal and non-steroidal observation is also supported by Stephen- anti-inflammatory drugs. son TJ et al. who found the selective ex- However Tait J. et al. identified a micro- pression of nuclear estrogen receptor in biological cause in 4 patients of a cohort trigonal epithelium of 10 women affected of 31 individuals referred to their attention by trigonitis, in a distribution similar to that with a diagnosis of recurrent urethral syn- reported in vaginal epithelium by other drome.4 Cystoscopy hardly contributes to workers. In this case the authors suggest an diagnosis cause it reveals hyperemia and oestrogen mediated aetiology of trigonitis squamous aspect of the bladder mucosa at speculating that it could be consistent with trigone level. In his population, Tait noted an embryological derivation of the trigone, trigonitis at cystoscopy in 26 of the 31 pa- distinct from that of the rest of the blad- tients and bladder biopsies showed squa- der.9 An association has been found among mous metaplasia in 15 and lymphocytic in- trigonitis, intestinal disorders, and inflam- filtration of the lamina propria in 29. These matory lesions of the genital tract (uterine findings give support to an inflammatory cervix). Since 1956 J.E. Semple of the St. aetiology of this enigmatic condition and Paul’s Hospital, London, reporting his ex- confirm the hard association between ure- perience in 43 females with trigonitis, has thral syndrome and trigonitis5. Further evi- described that 11 subjects presented with dence of this association is provided by Car- lesions of the large intestine (diverticula reras, who reported 68% of urethritis alone and radiologic appearances of inflamma- or combined with trigonitis in a cohort of tion).10 However, he suggested that the cor- 350 women presenting LUTS.6 In addition, relations between bowel inflammation and this author specified that urine examination trigonitis was not so strong as the associa- and cultures resulted negative in 80% of tion that he found with alteration of the cer- this population. Bladder histology in these vix and genital tract (in 66% of patients). patients shows pathological findings. Nor- In his experience, Semple firstly suggested mal trigonal urothelium consists of 3 cell the chance of treating these patients by layers (basal, intermediate and superficial), endoscopic fulguration of the bladder or whereas trigonitis constitutes many lay- urethral calibration.10-12 However, urethral ers of stratified squamous epithelium. The calibration is not useful in patients with basal cells contain prominent nuclei with normal micturition parameters as the pa- condensed chromatin, nucleoli and nuclear tients enrolled in our protocol. Endoscopic bodies. The cytoplasm of these cells is rich treatment is considered invasive but it is in mitochondria. The profiles of the urothe- still widely used for treating this condition lial cells become progressively elongated, by monopolar or bipolar fulguration of the their nuclei increasingly smaller and their inflammatory area of the bladder trigone. content of cell organelles gradually reduced However, no randomized prospective trials as the luminal surface is approached. The have been developed on this therapeutic squamous surface cells, linked by desmo- option and no level of evidence is therefore somes, retain many longitudinally arranged available regarding its efficacy and safety. fine filaments, together with an occasional Only Costantini et al. reported the results of 2 MINERVA UROLOGICA E NEFROLOGICA December 2014 Efficacy OF CISTIqUER IN improving lowER URINARy tract Symptoms PALLESCHI a prospective randomized study on surgical contribute to reduce inflammation and pain, treatment using Nd:yAG laser in 62 patients and to preserve the integrity of urothelium with trigonitis refractory to drugs.1 This and connective tissue of the bladder. quer- study concluded that side-firing laser, which citin, the principal, is a flavonoid, a plant produces necrotic coagulation followed by pigment with a molecular structure like or reconstitution of normal functional epithe- derived from flavone. It is found in fruits, lium, was significantly more successful than vegetables, leaves and grains. It can be used end-firing and was associated with a 78% as an ingredient in supplements, beverages, success rate. These results are encourag- or foods. Several laboratory studies show ing in patients who are usually refractory quercetin may have anti-inflammatory prop- to medical therapy. Medical therapy options erties and it is being investigated for a wide are represented by oral anti-inflammatory range of potential health benefits.16, 17 A drugs which determine short-time relief of study with rats showed that quercetin effec- symptoms and are very often followed by tively reduced immediate-release niacin (vi- recurrence. One of the most used treatment tamin B3) flush, in part by means of reduc- is represented by topic administration of ing prostaglandin D2 production.18 A
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