Clinical trial NCT03549650 - References

Lower Urinary Tract Symptoms — Prevention and Management of Intravesical BCG-related Lower Urinary Tract Symptoms

Citation(s)

•   Abdo KM, Johnson JD, Nyska A
  Toxicity and carcinogenicity of Elmiron in F344/N rats and B6C3F1 mice following 2 years of gavage administration. Arch Toxicol. 2003 Dec;77(12):702-11. Epub 2003 Sep 24.
•   Anderson VR, Perry CM
  Pentosan polysulfate: a review of its use in the relief of bladder pain or discomfort in interstitial cystitis. Drugs. 2006;66(6):821-35. Review.
•   Brausi M, Oddens J, Sylvester R, Bono A, van de Beek C, van Andel G, Gontero P, Turkeri L, Marreaud S, Collette S, Oosterlinck W
  Side effects of Bacillus Calmette-Guérin (BCG) in the treatment of intermediate- and high-risk Ta, T1 papillary carcinoma of the bladder: results of the EORTC genito-urinary cancers group randomised phase 3 study comparing one-third dose with full dose and 1 year with 3 years of maintenance BCG. Eur Urol. 2014 Jan;65(1):69-76. doi: 10.1016/j.eururo.2013.07.021. Epub 2013 Jul 24.
•   Brausi M, Witjes JA, Lamm D, Persad R, Palou J, Colombel M, Buckley R, Soloway M, Akaza H, Böhle A
  A review of current guidelines and best practice recommendations for the management of nonmuscle invasive bladder cancer by the International Bladder Cancer Group. J Urol. 2011 Dec;186(6):2158-67. doi: 10.1016/j.juro.2011.07.076. Epub 2011 Oct 19. Review.
•   Chuang YC, Lee WC, Lee WC, Chiang PH
  Intravesical liposome versus oral pentosan polysulfate for interstitial cystitis/painful bladder syndrome. J Urol. 2009 Oct;182(4):1393-400. doi: 10.1016/j.juro.2009.06.024. Epub 2009 Aug 15.
•   Colombel M, Saint F, Chopin D, Malavaud B, Nicolas L, Rischmann P
  The effect of ofloxacin on bacillus calmette-guerin induced toxicity in patients with superficial bladder cancer: results of a randomized, prospective, double-blind, placebo controlled, multicenter study. J Urol. 2006 Sep;176(3):935-9.
•   Davis EL, El Khoudary SR, Talbott EO, Davis J, Regan LJ
  Safety and efficacy of the use of intravesical and oral pentosan polysulfate sodium for interstitial cystitis: a randomized double-blind clinical trial. J Urol. 2008 Jan;179(1):177-85. Epub 2007 Nov 14.
•   de Reijke TM, de Boer EC, Kurth KH, Schamhart DH
  Urinary cytokines during intravesical bacillus Calmette-Guerin therapy for superficial bladder cancer: processing, stability and prognostic value. J Urol. 1996 Feb;155(2):477-82.
•   De Reijke TM, De Boer LC, Steerenberg PA, Vos PC, Kurth KH, Schamhart DH
  The effects of intravesical pretreatment with pentosan polysulfate on the bacillus Calmette-Guérin induced immune reaction of the guinea pig. J Urol. 1994 Mar;151(3):746-9.
•   Gontero P, Bohle A, Malmstrom PU, O'Donnell MA, Oderda M, Sylvester R, Witjes F
  The role of bacillus Calmette-Guérin in the treatment of non-muscle-invasive bladder cancer. Eur Urol. 2010 Mar;57(3):410-29. doi: 10.1016/j.eururo.2009.11.023. Epub 2009 Nov 13. Review.
•   Grigsby PW, Pilepich MV, Parsons CL
  Preliminary results of a phase I/II study of sodium pentosanpolysulfate in the treatment of chronic radiation-induced proctitis. Am J Clin Oncol. 1990 Feb;13(1):28-31.
•   Kassouf W, Traboulsi SL, Kulkarni GS, Breau RH, Zlotta A, Fairey A, So A, Lacombe L, Rendon R, Aprikian AG, Siemens DR, Izawa JI, Black P
  CUA guidelines on the management of non-muscle invasive bladder cancer. Can Urol Assoc J. 2015 Sep-Oct;9(9-10):E690-704. doi: 10.5489/cuaj.3320. Epub 2015 Oct 13.
•   Lamm DL, van der Meijden PM, Morales A, Brosman SA, Catalona WJ, Herr HW, Soloway MS, Steg A, Debruyne FM
  Incidence and treatment of complications of bacillus Calmette-Guerin intravesical therapy in superficial bladder cancer. J Urol. 1992 Mar;147(3):596-600.
•   Ludwig AT, Moore JM, Luo Y, Chen X, Saltsgaver NA, O'Donnell MA, Griffith TS
  Tumor necrosis factor-related apoptosis-inducing ligand: a novel mechanism for Bacillus Calmette-Guérin-induced antitumor activity. Cancer Res. 2004 May 15;64(10):3386-90.
•   National Toxicology Program
  NTP technical report on the toxicology and carcinogenesis studies of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) (CAS No. 1746-01-6) in female Harlan Sprague-Dawley rats (Gavage Studies). Natl Toxicol Program Tech Rep Ser. 2006 Apr;(521):4-232.
•   Nyström E, Sjöström M, Stenlund H, Samuelsson E
  ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence. Neurourol Urodyn. 2015 Nov;34(8):747-51. doi: 10.1002/nau.22657. Epub 2014 Aug 22.
•   Oddens J, Brausi M, Sylvester R, Bono A, van de Beek C, van Andel G, Gontero P, Hoeltl W, Turkeri L, Marreaud S, Collette S, Oosterlinck W
  Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guérin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance. Eur Urol. 2013 Mar;63(3):462-72. doi: 10.1016/j.eururo.2012.10.039. Epub 2012 Nov 2.
•   Schamhart DH, de Boer EC, Kurth KH
  Interaction between bacteria and the lumenal bladder surface: modulation by pentosan polysulfate, an experimental and theoretical approach with clinical implication. World J Urol. 1994;12(1):27-37.
•   Sylvester RJ, Brausi MA, Kirkels WJ, Hoeltl W, Calais Da Silva F, Powell PH, Prescott S, Kirkali Z, van de Beek C, Gorlia T, de Reijke TM; EORTC Genito-Urinary Tract Cancer Group
  Long-term efficacy results of EORTC genito-urinary group randomized phase 3 study 30911 comparing intravesical instillations of epirubicin, bacillus Calmette-Guérin, and bacillus Calmette-Guérin plus isoniazid in patients with intermediate- and high-risk stage Ta T1 urothelial carcinoma of the bladder. Eur Urol. 2010 May;57(5):766-73. doi: 10.1016/j.eururo.2009.12.024. Epub 2009 Dec 18.
•   Teichman JM
  The role of pentosan polysulfate in treatment approaches for interstitial cystitis. Rev Urol. 2002;4 Suppl 1:S21-7.
•   Vegt PD, van der Meijden AP, Sylvester R, Brausi M, Höltl W, de Balincourt C
  Does isoniazid reduce side effects of intravesical bacillus Calmette-Guerin therapy in superficial bladder cancer? Interim results of European Organization for Research and Treatment of Cancer Protocol 30911. J Urol. 1997 Apr;157(4):1246-9.
•   Yadav S, Tomar V, Yadav SS, Priyadarshi S, Banerjee I
  Role of oral pentosan polysulphate in the reduction of local side effects of BCG therapy in patients with non-muscle-invasive bladder cancer: a pilot study. BJU Int. 2016 Nov;118(5):758-762. doi: 10.1111/bju.13489. Epub 2016 Apr 23.

Prevention and Management of Intravesical BCG-related Lower Urinary Tract Symptoms With Prophylactic Pentosan Polysulphate in Patients With Non-Muscle-Invasive Bladder Cancer: A Randomized Controlled Trial

Details for clinical trial NCT03549650