Efficiency and safety of phenazopyridine for treatment of uncomplicated urinary tract infection: results of multi-center, randomized, placebo-controlled, clinical study


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

Aim: to evaluate the efficiency and safety of phenazopyridine for the treatment of patients with uncomplicated lower urinary tract infection, accompanied by pain. Materials and methods. A multicenter double-blind, randomized, placebo-controlled study with parallel groups to evaluate the efficacy and safety of phenazopyridine in patients with acute uncomplicated cystitis was performed. A total of 60 women were divided into two groups of 30 patients. In the main group (average age 32.6±7.4 years) phenazopyridine was prescribed (2 tablets of 100 mg p.o., with a total dose of 200 mg, once). In the control group, patients (mean age 35.53±8.79 years) received a placebo according to the same scheme. To evaluate the efficiency of treatment, the severity of the main symptoms 6 hours after taking the drug was analyzed. After that, patients started antibiotic therapy. They were followed-up for the next three days. The tolerance of therapy was evaluated by the presence of adverse events. Results. All 30 patients taking phenazopyridine had an improvement after 6 hours, and the most frequent response was “significant improvement” (43.3%). The responses of patients in the main group significantly (p<0.05) differed from responses of patients in the control group. Six hours after taking phenazopyridine/placebo, the severity of all values according to VAS score, including the degree of general discomfort, pain during urination and increased frequency of urination improved significantly in the main group compared to the control group. The average assessment of general discomfort in the main group decreased by 53.4% in comparison with 28.8% in the control group, while the severity of pain during urination and urination frequency decreased by 57.4 vs. 35.9% and 39.6 vs. 27.6%, respectively. An analysis of the time before the complete absence of the general discomfort was performed. In the main group this period of time was significantly less than in the control group (p<0.05). There were no serious adverse events while taking phenazopyridine. Rate of adverse events was comparable between two groups. Conclusion. The results of the study showed that phenazopyridine is an effective and well-tolerated drug for symptomatic therapy in patients with acute uncomplicated cystitis and can be recommended in addition to etiological therapy.

Full Text

Restricted Access

About the authors

S. B. Petrov

Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia

Email: petrov-uro@yandex.ru
Dr.Med.Sci., professor, Head of the Scientific and Research Center of Urology. Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia Saint Petersburg, Russia

M. N Slesarevskaya

Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia

Email: mns-1971@yandex.ru
M.N. - Ph.D., senior researcher at Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia Saint Petersburg, Russia

K. H Chibirov

FGBOU Saint Petersburg Scientific and Research Institute of Phthisiopulmonology of Ministry of Health of Russia (Department of phthisionephrology and urology)

Email: ckk_mma@mail.ru
urologist, Department of Phthisionephrology and urology, FGBOU Saint Petersburg Scientific and Research Institute of Phthisiopulmonology of Ministry of Health of Russia Saint Petersburg, Russia

M. E Topuzov

North-Western State Medical University n.a. I.I. Mechnikov

Email: martop@mail.ru
Dr.Med.Sci, MD, professor at the Department of Urology, North-Western State Medical University n.a. I.I. Mechnikov Saint Petersburg, Russia

O. F Kagan

Ltd MedEsteticCenter Laboratory

Email: ofkagan@mail.ru
Dr.Med.Sci, MD, Ltd MedEsteticCenter Laboratory Saint Petersburg, Russia

E. N Voronova

Ltd Avrora Medi

Email: Nickolaevna@mail.ru
urologist at the Ltd Avrora Medi Saint Petersburg, Russia

References

  1. Foxman B., Brown P. Epidemiology of urinary tract infections: Transmission and risk factors, incidence, and costs. Infect. Dis. Clin. N. Am. 2003;17:227-241. doi: 10.1016/s0891-5520(03)00005-9
  2. Ronald A.R., Nicolle L.E., Stamm E., Krieger J., Warren J., Schaeffer A., Naber K.G., Hooton T.M., Johnson J., Chambers S. et al. Urinary tract infection in adults: Research priorities and strategies. Int. J. Antimicrob. Agents 2001;17:343-348. doi: 10.1016/s0924-8579(01)00303-x
  3. Bonkat G., Pickard R., Bartolett R. et al. Urological Infections EAU Guidelines, 2020. http://uroweb.org/guideline/urological-infections
  4. Naber K.G., Cho Y.H., Matsumoto T., Schaeffer A.J. Immunoactive prophylaxis of recurrent urinary tract infections: a meta-analysis. Int. J. Antimicrob. Agents. 2009;33(2):111-119.
  5. Yang H.J., Kim Y.H., Kim M.E. A Preliminary Study of Troublesome Symptoms in Women with Acute Uncomplicated Cystitis Korean J urol. 2007;48:1082-1087.
  6. Кузьмин И.В., Аль-Шукри С.Х., Слесаревская М.Н. Лечение и профилактика рецидивирующей инфекции нижних мочевых путей у женщин. Урологические ведомости. 2019;9(2):5-10). Doi: 10.17816/ uroved925-10.
  7. Борисов В.В. Диагностика и терапия инфекций мочевыводящих путей. О чем следует помнить всегда (клиническая лекция). Часть 1. Урологические ведомости. 2017;7(3):52-59. doi: 10.17816/uroved7352-59.
  8. Аль-Шукри С.Х., Слесаревская М.Н., Кузьмин И.В. Применение фосфомицина при лечении неосложненной инфекции нижних мочевыводящих путей. Урология. 2018;5:153-159.
  9. Перепанова Т.С., Козлов Р.С. и др. Антимикробная терапия и профилактика инфекций почек, мочевыводящих путей и мужских половых органов. Федеральные клинические рекомендации. М., 2020. 110 с.
  10. Страчунский Л.С. Норфлоксацин (Ноцилин) в лечении инфекций мочевыводящих путей / Материалы международного симпозиума: «Инфекции мочевыводящих путей у амбулаторных больных» 16 февраля 1999 г. М., 1999. Р. 29-32.
  11. Амдий Р.Э., Аль-Шукри С.Х., Кузьмин И.В., Сорокин Н.В., Чаплицкий Е.А., Скворцов М.В., Алексеев А.С., Окунчаев А.Ш., Турбин А.А., Тимаева Г.Р., Булаев Д.В., Москалева Ю.С. Опыт применения канефрона при лечении острого неосложненного цистита у женщин Урологические ведомости. 2016;6(2):16-22.
  12. Kyungtae Ko, Won Ki Lee, Cheol Young Oh et al. Is A Combination of Antibiotics and Non-Steroidal Anti-Inflammatory Drugs More Beneficial Than Antibiotic Monotherapy For The Treatment of Female Acute Uncomplicated Cystitis? A Randomized Controlled Pilot Study. Female Urology. 2018;15(06):365-369. doi: 10.22037/uj.v0i0.3716.
  13. Sri Sivalingam, Manoj Monga. Management of Ureteral Stent Discomfort in Contemporary Urology Practice. Urology Practice 1. 2014:141-145. doi: 10.1016/j.urpr.2014.06.001.
  14. Thomas B.H., Whitehouse L.W., Solomonraj G., Paul C.J. Excretion of phenazopyridine and its metabolites in the urine of humans, rats, mice and guinea pigs. J Pharm Sci 1990;79(4):321-325.
  15. Wander H.J., Pascoe D.J. Phenylazopyridine hydrochloride poisoning. Report of case and review of literature. Am. J. Dis. Child. 1965;110:105-107.
  16. Pergialiotis V., Arnos P.,Mavros M.N.,Pitsouni E.,Athanasiou S.,Falagas M.E. Urinary tract analgesics for the treatment of patients with acute cystitis: where is the clinical evidence? Expert Rev Anti Infect Ther. 2012;10(8):875-879. doi: 10.1586/eri.12.72.
  17. Aizawa N., Wyndaele J.J. Effects ofphenazopyridine on rat bladder primary afferent activity, and comparison with lidocaine and acetaminophen. Neurofuran Urodyn. 2010;29(8):1445-1450. doi: 10.1002/nau.20886.
  18. Trickett P.C. Ancillary use of phenazopyridine (Pyridium) in urinary tract infections. Curr. Ther. Res. Clin. Exp. 1970;12(7):441-445.
  19. Anderson C., Chimhanda M., Sloan J., Galloway S., Sinacore J., Brubaker L. Phenazopyridine does not improve catheter discomfort following gynecologic surgery. Am. J. Obstet. Gynecol. 2011; 204(3):267.e1-267.e3.
  20. Gilderman L., Hendry D., Patrick K. Evaluation of the efficacy of phenazopyridine Hydrochloride (Formula PD-F-0016) as a urinary analgesic in women with urinary tract infections. FDA’s Dockets Management. Protocol Number: 99-001-P (2001).
  21. Deepalatha C., Deshpande N. A comparative study of phenazopyridine (pyridium) and cystone as short-term analgesic in uncomplicated urinary tract infection. Int J Pharm Sci 2011;3(Suppl. 2):224-226.
  22. Pyridium drug description. Available at: www.rxlist.com
  23. Shireen N. Farzadeh, Emily M. Ambizas Urinary Tract Infections and Self-Care Options. Infectious disease 15, 2017 https://www. uspharmacist.com/article/urinary-tract-infections-and-selfcare-options
  24. Винаров А.З., Спивак Л.Г. Современные возможности симптоматической терапии дизурии. Урология. 2019;2:97-102. https://dx.doi.org/10.18565/urology.2019.2.97-102.
  25. Duenas-Garcia O.F., Sierra T., Taylor D., Leung K., Hall C.D., Flynn M.K. The Effect of Oral Phenazopyridine on Perioperative Voiding After Midurethral Slings (EPIPhANy Study). Female Pelvic Med Reconstr Surg. 2018;24(2):95-99. doi: 10.1097/SPV.0000000000000497.
  26. Norris R.D., Sur R.L., Springhart W.P., Marguet C.G., Mathias B.J., Pietrow P.K., Albala D.M., Preminger G.M. A prospective, randomized, double-blinded placebo-controlled comparison of extended release oxybutynin versus for the management of postoperative ureteral stent discomfort. Urology. 2008;71(5):792-795.
  27. Рафальский В.В., Моисеева Е.М. Эпидемиология неосложненных внебольничных инфекций мочевыводящих путей в Российской Федерации. Вестник урологии. 2018;6(2):30-37. doi: 10.21886/2308-6424- 2018-6-2-30-37

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

Copyright (c) 2020 Bionika Media

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies