Top

Published in:

Open Access 01-12-2016 | Research article

An observational study of the use of beclomethasone dipropionate suppositories in the treatment of lower urinary tract inflammation in men

Authors: Giorgio Bozzini, Marco Provenzano, Nicolò Buffi, Mauro Seveso, Giovanni Lughezzani, Giorgio Guazzoni, Alberto Mandressi, Gianluigi Taverna

Published in: BMC Urology | Issue 1/2016

Abstract

Background

Nonbacterial prostatitis, together with chronic pelvic pain syndrome, accounts for 90–95 % of prostatitis cases. Anti-inflammatory medications are commonly used to reduce storage/inflammatory symptoms that can deteriorate quality of life. The purpose of this study was to observe the efficacy and safety of beclomethasone dipropionate rectal suppositories (Topster®) in inflammations of the lower urinary tract in men.

Methods

Patients underwent diagnostic and therapeutic protocols according to current evidence-based practice. Efficacy assessments: voiding parameters, perineal pain, International Prostate Symptom Score (IPSS), digital rectal examination (DRE). Adverse events and patient compliance were recorded throughout the study.

Results

One hundred eighty patients were enrolled, mean age 52 ± 14.97. Most frequent diagnosis: nonbacterial prostatitis (85 %). All patients completed visits 1 and 2. All patients were treated with beclomethasone dipropionate (BDP) suppositories, 136/180 also with Serenoa repens (SR) extract. Antibiotics were rarely required.

162/180 patients presented clinically significant improvements and terminated treatment.

Mean change vs. baseline in voiding frequency: −3.55 ± 2.70 n/day in patients taking only BDP and −3.68 ± 2.81 n/day in those taking both BDP and SR (P<.0001 in both groups). Uroflowmetry improved significantly; change from baseline 3.26 ± 5.35 ml/s in BDP only group and 5.61 ± 7.32 ml/s in BDP + SR group (P = 0.0002 for BDP, P<.0001 for BDP + SR). Urine stream normal in 35 % of patients at visit 1 and 57.22 % of patients at visit 2. Mean change in perineal pain, on 0–10 VAS, −0.66 ± 2.24 for BDP only group (P = 0.0699) and −1.37 ± 2.40 for BDP + SR group (P<.0001). IPSS increased at visit 2. No adverse events were reported.

For all parameters, none of the comparisons between groups was found to be statistically significant.

Conclusion

This study confirmed the drug’s good safety profile. We also observed an improvement in the main storage symptoms and clinical findings associated with lower urinary tract inflammation in patients treated with beclomethasone dipropionate suppositories.

Rees J, Abrahams M, Doble A, Cooper A. Prostatitis Expert Reference Group (PERG). Diagnosis and treatment of chronic bacterial prostatitis and chronic prostatitis/chronic pelvic pain syndrome: a consensus guideline. BJU Int. 2015 Feb 24; doi:10.1111/bju.13101.

Gurunadha Rao Tunuguntla HS, Evans CP. Management of prostatitis. Prostate Cancer and Prostatic Dis. 2002;5(3):172–9.CrossRef

Collins MM, Stafford RS, O'Leary MP, Barry MJ. How common is prostatitis? A national survey of physician visits. J Urol. 1998;159:1224–8.CrossRefPubMed

Artibani W, Pesce F, Prezioso D, Scarpa RM, Zattoni F, Tubaro A, Rizzi CA, Santini AM, Simoni L. FLOW study group. Italian validation of the urogenital distress inventory and its application in LUTS patients. Eur Urol. 2006;50(6):1323–9.CrossRefPubMed

Bartoletti R, Cai T, Mondaini N, et al. Prevalence, incidence estimation, risk factors and characterization of chronic prostatitis/chronic pelvic pain syndrome in urological hospital outpatients in Italy: results of a multicenter case–control observational study. J Urol. 2007;178(6):2411–5.CrossRefPubMed

Wagenlehner Florian ME et al. Prostatitis and Male Pelvic Pain Syndrome. Dtsch Arztebl Int. 2009;106(11):175–83.PubMedPubMedCentral

Öztekin I et al. Therapeutic Effects of Oligonol, Acupuncture, and Quantum Light Therapy in Chronic Nonbacterial Prostatitis. Evid Based Complement Alternat Med. 2015;2015:687196.CrossRefPubMedPubMedCentral

Yang MG, Zhao XK, Wu ZP, et al. Corticoid combined with an antibiotic for chronic nonbacterial prostatitis. Zhonghua Nan Ke Xue. 2009;15(3):237–40.PubMed

Talbot M, Bates S. Variability of the symptoms of chronic abacterial prostatitis/chronic pelvic pain syndrome during intermittent therapy with rectal prednisolone foam for ulcerative colitis. Int J STD AIDS. 2001;12(11):752–3.CrossRefPubMed

10.

Fascì Spurio F et al. Low Bioavailability and Traditional Systemic Steroids in IBD: Can the Former Take Over the Latter? Gastrointestin Liver Dis. 2013;22(1):65–71.

11.

Campieri M. New steroids and new salicylates in inflammatory bowel disease: a critical appraisal. Gut. 2002;50(Suppl III):iii43–6.PubMedPubMedCentral

12.

Kumana CR, Seaton T, Meghji M, Castelli M, Benson R, Sivakumaran T. Beclomethasone dipropionate enemas for treating inflammatory bowel disease without producing Cushing's syndrome or hypothalamic pituitary adrenal suppression. Lancet. 1982;1(8272):579–83.CrossRefPubMed

13.

Cohen RD1, Dalal SR. Systematic Review: Rectal Therapies for the Treatment of Distal Forms of Ulcerative Colitis. Inflamm Bowel Dis. 2015 May 27. [Epub ahead of print].

14.

Barry MJ, Fowler Jr FJ, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. Journal of Urology. 1992;148(5):1549–57.PubMed

15.

Naber KG, Bergman B, Bishop MC, Bjerklund-Johansen TE, Botto H, Lobel B, Jinenez Cruz F, Selvaggi FP. EAU guidelines for the management of urinary and male genital tract infections. Eur Urol. 2001;40(5):576–88.CrossRefPubMed

16.

Grabe M, Bartoletti R, Bjerklund Johansen TE, Cai T, Çek M, Köves B, Naber KG, Pickard RS, Tenke P, Wagenlehner F, Wullt B. Guidelines on Urological Infections. http://uroweb.org/guideline/urological-infections/. Accessed 04 Aug 2015.

17.

Bernichtein S et al. Anti-Inflammatory properties of Lipidosterolic extract of Serenoa repens (Permixon®) in a mouse model of prostate hyperplasia. Prostate. 2015;75(7):706–22.CrossRefPubMed

18.

Debruyne F, Boyle P, Calais Da Silva F, Gillenwater JG, Hamdy FC, Perrin P, Teillac P, Vela-Navarrete R, Raynaud JP, Schulman CC. Evaluation of the clinical benefit of permixon and tamsulosin in severe BPH patients-PERMAL study subset analysis. Eur Urol. 2004;45(6):773–9. discussion 779–80.CrossRefPubMed

19.

Debruyne F, Koch G, Boyle P, Da Silva FC, Gillenwater JG, Hamdy FC, Perrin P, Teillac P, Vela-Navarrete R, Raynaud JP. Comparison of a phytotherapeutic agent (Permixon) with an alpha-blocker (Tamsulosin) in the treatment of benign prostatic hyperplasia: a 1-year randomized international study. Eur Urol. 2002;41(5):497–506. discussion 506–7.CrossRefPubMed

20.

Latil A, Pétrissans MT, Rouquet J, Robert G, de la Taille A. Effects of hexanic extract of serenoa repens (permixon(®) 160 mg) on inflammation biomarkers in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. Prostate. 2015;75(16):1857–67.CrossRefPubMed

21.

Magri V, Marras E, Restelli A, Wagenlehner FM, Perletti G. Multimodal therapy for category III chronic prostatitis/chronic pelvic pain syndrome in UPOINTS phenotyped patients. Exp Ther Med. 2015;9(3):658–66.PubMed

22.

Morgia G et al. Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial). Prostate. 2014;74(15):1471–80.CrossRefPubMed

23.

Lee HN, Kim TH, Lee SJ, Cho WY, Shim BS. Effects of prostatic inflammation on LUTS and alpha blocker treatment outcomes. Int Braz J Urol. 2014;40(3):356–66.CrossRefPubMed

24.

Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. IUGA/ICS Joint Report On The Terminology For Female Pelvic Floor Dysfunction: Standardisation and Terminology Committees IUGA and ICS, Joint IUGA/ICS Working Group on Female Terminology. Neurourol Urodyn. 2010;29(1):4–20.PubMed

25.

Matsukawa Y, Hattori R, Sassa N, Yamamoto T, Gotoh M. What are the factors contributing to failure in improvement of subjective symptoms following silodosin administration in patients with benign prostatic hyperplasia? Investigation using a pressure-flow study. Neurourol Urodyn. 2013;32(3):266–70.CrossRefPubMed

26.

Park SG, Chung BH, Lee SW, Park JK, Park K, Cheon J, Lee KS, Kim HJ, Seong DH, Oh SJ, Kim SW, Lee JY, Choo SH, Choi JB. Alpha-blocker treatment response in men with lower urinary tract symptoms based on sympathetic activity: prospective multicenter open-Labeled observational study. Int Neurourol J. 2015;19(2):107–12.CrossRefPubMedPubMedCentral

27.

Fujimura T et al. Assessment of lower urinary tract symptoms in men by international prostate symptom score and core lower urinary tract symptom score. BJU Int. 2012;109(10):1512–6.CrossRefPubMed

Title: An observational study of the use of beclomethasone dipropionate suppositories in the treatment of lower urinary tract inflammation in men
Authors: Giorgio Bozzini
Marco Provenzano
Nicolò Buffi
Mauro Seveso
Giovanni Lughezzani
Giorgio Guazzoni
Alberto Mandressi
Gianluigi Taverna
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: BMC Urology / Issue 1/2016
Electronic ISSN: 1471-2490
DOI: https://doi.org/10.1186/s12894-016-0144-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

An observational study of the use of beclomethasone dipropionate suppositories in the treatment of lower urinary tract inflammation in men

Abstract

Background

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 1/2016

The combination of herbal medicine Weng-li-tong with Tolterodine may be better than Tolterodine alone in the treatment of overactive bladder in women: a randomized placebo-controlled prospective trial

Cancer-specific and overall survival in patients with recurrent prostate cancer who underwent salvage extended pelvic lymph node dissection

Prolonged CT urography in duplex kidney

Bacillus Calmette-Guerin therapy after the second transurethral resection significantly decreases recurrence in patients with new onset high-grade T1 bladder cancer

Unilateral congenital giant megaureter with renal dysplasia compressing contralateral ureter and causing bilateral hydronephrosis: a case report and literature review

Abiraterone acetate in metastatic castration-resistant prostate cancer – the unanticipated real-world clinical experience