15. References

Phillips B. Oxford Centre for Evidence-based Medicine Levels of Evidence. Updated by Jeremy Howick March 2009. 1998.
https://www.cebm.ox.ac.uk/resources/levels-of-evidence/oxford-centre-for-evidence-based-medicine-levels-of-evidence-march-2009
International Agency for Research on Cancer. Estimated number of new cases in 2020, worldwide, both sexes, all ages. World Health Organization. 2021.
https://gco.iarc.fr/today/en
Comperat E, Larre S, Roupret M, et al. Clinicopathological characteristics of urothelial bladder cancer in patients less than 40 years old. Virchows Arch. 2015;466:589–94.
https://www.ncbi.nlm.nih.gov/pubmed/25697540
Burger M, Catto JW, Dalbagni G, et al. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol. 2013;63:234–41.
https://www.ncbi.nlm.nih.gov/pubmed/22877502
Teoh JY, Huang J, Ko WY, et al. Global Trends of Bladder Cancer Incidence and Mortality, and Their Associations with Tobacco Use and Gross Domestic Product Per Capita. Eur Urol. 2020;78:893–906.
https://www.ncbi.nlm.nih.gov/pubmed/32972792
Freedman ND, Silverman DT, Hollenbeck AR, et al. Association between smoking and risk of bladder cancer among men and women. Jama. 2011;306:737–45.
https://www.ncbi.nlm.nih.gov/pubmed/21846855
Laaksonen MA, MacInnis RJ, Canfell K, et al. The future burden of kidney and bladder cancers preventable by behavior modification in Australia: A pooled cohort study. Int J Cancer. 2020;146:874–83.
https://www.ncbi.nlm.nih.gov/pubmed/31107541
Colt JS, Friesen MC, Stewart PA, et al. A case-control study of occupational exposure to metalworking fluids and bladder cancer risk among men. Occup Environ Med. 2014;71:667–74.
https://www.ncbi.nlm.nih.gov/pubmed/25201311
Pesch B, Taeger D, Johnen G, et al. Screening for bladder cancer with urinary tumor markers in chemical workers with exposure to aromatic amines. Int Arch Occup Environ Health. 2014;87:715–24.
https://www.ncbi.nlm.nih.gov/pubmed/24129706
Tyagi P, Tyagi S, Kaufman J, et al. Local drug delivery to bladder using technology innovations. Urol Clin North Am. 2006;33:519-30.
http://www.ncbi.nlm.nih.gov/pubmed/17011388
Shariat SF, Chade DC, Karakiewicz PI, et al. Update on intravesical agents for non-muscle-invasive bladder cancer. Immunotherapy. 2010;2:381-92.
http://www.ncbi.nlm.nih.gov/pubmed/20635902
Abern MR, Owusu RA, Anderson MR, et al. Perioperative intravesical chemotherapy in non-muscle-invasive bladder cancer: a systematic review and meta-analysis. Journal of the National Comprehensive Cancer Network: JNCCN. 2013;11:477–84.
http://www.ncbi.nlm.nih.gov/pubmed/23584348
Gandhi NM, Morales A, Lamm DL. Bacillus Calmette-Guerin immunotherapy for genitourinary cancer. BJU International. 2013;112:288––97
http://www.ncbi.nlm.nih.gov/pubmed/23517232
Gontero P, Birtle A, Comperat E, Liedberg P. EAU Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and CIS). 2025
https://uroweb.org/guidelines/non-muscle-invasive-bladder-cancer
Schmidt S, Kunath F, Coles B, Draeger DL, Krabbe LM, Dersch R, et al. Intravesical Bacillus Calmette-Guerin versus mitomycin C for Ta and T1 bladder cancer. The Cochrane database of systematic reviews. 2020;1:CD011935
https://www.ncbi.nlm.nih.gov/pubmed/31912907
Scilipoti P, Slusarczyk A, de Angelis M, Soria F, Pradere B, Krajewski W, et al. The Role of Mitomycin C in Intermediate-risk Non-muscle-invasive Bladder Cancer: A Systematic Review and Meta-analysis. Eur Urol Oncol. 2024
https://www.ncbi.nlm.nih.gov/pubmed/38902138
Health Products Regulatory Authority of Ireland. HPRA. Mitomycin medac 40mg powder - Summary of product characteristics. Accessed Jan 24th 2025.
https://www.hpra.ie/img/uploaded/swedocuments/Licence_PA0623-016- 002_26022024101510.pdf
Health Products Regulatory Authority of Ireland. HPRA. BCG-medac, powder and solvent for suspension for intravesical use - Summary od product characteristics. Accessed Jan 24th 2025.
https://www.hpra.ie/find-a-medicine/for-human-use/authorised-medicines/ details/19330
Bonkat G, Kranz J, Cai T, Geerlings SE, Koves B. EAU Guidelines on Urological Infections Edn. presented at the 40th Annual Congress Madrid. 2025
https://uroweb.org/guidelines/urological-infections
Herr HW. Intravesical bacillus Calmette-Guerin outcomes in patients with bladder cancer and asymptomatic bacteriuria. The Journal of urology. 2012;187:435––7
http://www.ncbi.nlm.nih.gov/pubmed/22177154
Anastasiadis Aa. Best practice in the treatment of nonmuscle invasive bladder cancer. Therapeutic Advances in Urology. 2012;4:13––32
http://www.ncbi.nlm.nih.gov/pubmed/22295042
Lamm DL, Blumenstein BA, Crissman JD, Montie JE, Gottesman JE, Lowe BA, et al. Maintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study. The Journal of urology. 2000;163:1124––9
http://www.ncbi.nlm.nih.gov/pubmed/10737480
Shore ND, Palou Redorta J, Robert G, Hutson TE, Cesari R, Hariharan S, et al. Non-muscle-invasive bladder cancer: An overview of potential new treatment options. Urol Oncol. 2021;39:642–63
https://www.ncbi.nlm.nih.gov/pubmed/34167873
Centers for Disease Control and Prevention. NIOSH List of Hazardous Drugs in Healthcare Settings, 2024. NIOSH. 2024.
https://www.cdc.gov/niosh/docs/2025-103/.
European Comission. Guidance for the safe management of hazardous medicinal products at work,. Directorate-General for Employment, Social Affairs and Inclusion. 2023
https://op.europa.eu/en/publication-detail/-/publication/8e504373-8a77-11ee-99ba-01aa75ed71a1/language-en
Occupational Safety and Health Administration. OSHA Technical Manual (OTM) OSHA Instruction TED 01-00-015 - Hazardous Drugs. Accessed Jan 24th 2025.
https://www.osha.gov/hazardous-drugs
European Parliament. Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC). 2004
https://eur-lex.europa.eu/eli/dir/2004/37/2024-04-08
Centers for Disease Control and Prevention. NIOSH Closed System Drug-Transfer Device (CSTD) Research. National Institute for Occupational Safety and Health. 2024
https://www.cdc.gov/niosh/healthcare/hazardous-drugs/cstd-research.html
Suspiro A, Prista J. Biomarkers of occupational exposure do anticancer agents: a minireview. Toxicology letters. 2011;207:42––52
http://www.ncbi.nlm.nih.gov/pubmed/21911042
Boiano JM, Hull RD. Development of a National Occupational Exposure Survey and Database associated with NIOSH hazard surveillance initiatives. Applied occupational and environmental hygiene. 2001;16:128––34
http://www.ncbi.nlm.nih.gov/pubmed/11217699
Fransman W. Antineoplastic drugs: Occupational exposure and health risks. 2006. p. 1––166.
Lawson CC, Rocheleau CM, Whelan EAa. Occupational exposures among nurses and risk of spontaneous abortion. American journal of obstetrics and gynecology. 2012;206:327.e1––8
http://www.ncbi.nlm.nih.gov/pubmed/22304790
McDiarmid MA, Oliver MS, Roth TS, Rogers B, Escalante C. Chromosome 5 and 7 abnormalities in oncology personnel handling anticancer drugs. Journal of occupational and environmental medicine / American College of Occupational and Environmental Medicine. 2010;52:1028––34
http://www.ncbi.nlm.nih.gov/pubmed/20881619
Meijster T, Fransman W, Veldhof R, Kromhout H. Exposure to antineoplastic drugs outside the hospital environment. The Annals of occupational hygiene. 2006;50:657––64
http://www.ncbi.nlm.nih.gov/pubmed/16679337
Rogers B, Emmett EA. Handling antineoplastic agents: urine mutagenicity in nurses. Image--the journal of nursing scholarship. 1987;19:108––13
http://www.ncbi.nlm.nih.gov/pubmed/3311973
Yoshida J, Tei G, Mochizuki C, Masu Y, Koda S, Kumagai S. Use of a closed system device to reduce occupational contamination and exposure to antineoplastic drugs in the hospital work environment. The Annals of occupational hygiene. 2009;53:153––60
http://www.ncbi.nlm.nih.gov/pubmed/19261696
Abu-Alhaija D, Bakas T, Shaughnessy E, Miller E. The Factors That Influence Chemotherapy Exposure Among Nurses: An Integrative Review. Workplace Health Saf. 2023;71:212–27
https://www.ncbi.nlm.nih.gov/pubmed/36703295
Brixey MT. Chemotherapeutic agents: intravesical instillation. Urologic Nursing. 1988;9:4––6
http://www.ncbi.nlm.nih.gov/pubmed/3145560
Games J. Nursing implications in the management of superficial bladder cancer. Seminars in Urologic Oncology. 1996;14:36––40
http://www.ncbi.nlm.nih.gov/pubmed/8727809
Mellinger E, Skinker L, Sears D, Gardner D, Shult P. Safe handling of chemotherapy in the perioperative setting. AORN Journal. 2010;91:435––53
http://www.ncbi.nlm.nih.gov/pubmed/20362210
Centers for Disease Control and Prevention. NIOSH Alert. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. National Institute for Occupational Safety and Health. 2004:1––58.
http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf
ASHP guidelines on compounding sterile preparations. Am J Health Syst Pharm. 2014;71:145–66
https://pubmed.ncbi.nlm.nih.gov/24375608/
Clark BA, Sessink PJM. Use of a closed system drug-transfer device eliminates surface contamination with antineoplastic agents. Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners. 2013;19:99––104
http://www.ncbi.nlm.nih.gov/pubmed/23292973
Landeck L, Gonzalez E, Koch OM. Handling chemotherapy drugs-Do medical gloves really protect? International journal of cancer Journal international du cancer. 2014
http://www.ncbi.nlm.nih.gov/pubmed/24978061.
M.M. PMO. Safe handling of hazardous drugs (3rd ed.). Oncology Nursing Society. 2018
Fransman W, Huizer D, Tuerk J, Kromhout H. Inhalation and dermal exposure to eight antineoplastic drugs in an industrial laundry facility. Int Arch Occup Environ Health. 2007;80:396––403
http://www.ncbi.nlm.nih.gov/pubmed/17021843.
Organon Teknika Corporation LLC. BCG Live (for intravesical use) TICE \textregistered BCG. 2009. p. 1––11.
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM163039.pdf
Raviv G, Pinthus JH, Shefi S, Mor Y, Kaufman-Francis K, Levron J, et al. Effects of intravesical chemotherapy and immunotherapy on semen analysis. Urology. 2005;65:765––7
http://www.ncbi.nlm.nih.gov/pubmed/15833524
Garg M, Sankhwar SN, Goel A, Kumar M, Singh BP, Singh V, et al. Effect of intravesical immunotherapy on sperm parameters in young patients with non--muscle-invasive bladder carcinoma: prospective analysis. Clinical genitourinary cancer. 2014;12:e83––6
http://www.ncbi.nlm.nih.gov/pubmed/24411194
Vahr Lauridsen S, Chagani S, Daniels A, et al. Urethral intermittent catheterisation in adults – including urethral intermittent dilatation - Evidence-based Guidelines for Best Practice in Urological Health Care. 1st ed: EAUN Office; 2024.
https://nurses.uroweb.org/guidelines/urethral-intermittent-catheterisation-in-adults
Roper N, Logan WW, Tierney AJ. The Roper-Logan-Tierney Model of Nursing: Based on Activities of Living. 1 ed: Elsevier Health Sciences.; 2000.
Kwan ML, Wang Z, Haque R, Lee VS, Roh JM, Ergas IJ, et al. The Influence of Dietary Isothiocyanates on the Effectiveness of Mitomycin C and Bacillus Calmette-Guérin in Treating Nonmuscle-Invasive Bladder Cancer. J Urol. 2024;212:420–30
https://pubmed.ncbi.nlm.nih.gov/38848543/
Cliff AM, Heatherwick B, Scoble J, N.J P. The effect of fasting or desmopressin before treatment on the concentration of mitomycin C during intravesical administration. BJU International. 2000;86:644––7
http://www.ncbi.nlm.nih.gov/pubmed/11069370
Rink M, Xylinas E, Babjuk M, Pycha A, Karakiewicz PI, Novara G, et al. Smoking reduces the efficacy of intravesical bacillus Calmette-Guerin immunotherapy in non-muscle-invasive bladder cancer. European urology. 2012;62:1201––6
http://www.ncbi.nlm.nih.gov/pubmed/22980442
Sfakianos JP, Shariat SF, Favaretto RL, Rioja J, Herr HW. Impact of smoking on outcomes after intravesical bacillus Calmette-Guerin therapy for urothelial carcinoma not invading muscle of the bladder. BJU International. 2011;108:526––30
http://www.ncbi.nlm.nih.gov/pubmed/21114611
Andius P, Damm O, Holmang S. Prognostic factors in patients with carcinoma in situ treated with intravesical bacille Calmette-Guerin. Scandinavian Journal of Urology and Nephrology. 2004;38:285––90
http://www.ncbi.nlm.nih.gov/pubmed/15669587
Stone MM, Vannier AM, Storch SK, Peterson C, Nitta AT, Zhang Y. Meningitis Due to Iatrogenic Bcg Infection in Two Immunocompromised Children — NEJM. The New England Journal of Medicine. 1995;333:561––3
http://www.nejm.org/doi/full/10.1056/NEJM199508313330905
Shelley MD, Mason MD, Kynaston H. Intravesical therapy for superficial bladder cancer: A systematic review of randomised trials and meta-analyses. Cancer Treatment Reviews. 2010;36:195––205
http://www.ncbi.nlm.nih.gov/pubmed/20079574
Badalament RA, Farah RN. Treatment of superficial bladder cancer with intravesical chemotherapy. Seminars in Surgical Oncology. 1997;13:335––41
http://www.ncbi.nlm.nih.gov/pubmed/9259089
Johnson MH, Nepple KG, Peck V, et al. Randomized controlled trial of oxybutynin extended release versus placebo for urinary symptoms during intravesical bacillus Calmette-Guerin treatment. Journal of Urology. 2013;189:1268––74
http://www.ncbi.nlm.nih.gov/pubmed/23123375
Shah JB, Kamat AM. Strategies for Optimizing Bacillus Calmette-Guerin. Urol Clin North Am. 2013;40:211–8.
http://www.ncbi.nlm.nih.gov/pubmed/23540779
Switters DM, Soares SE, White RWV. Nursing care of the patient receiving intravesical chemotherapy. Urol Nurs. 1992;12:136–9.
http://www.ncbi.nlm.nih.gov/pubmed/1465638
Hariri MK, Rajabalian M-B, Narouie B, rohollahpour S, Rostami G, Ahmadzade M. Comparison of the efficacy of BCG intravesical immunotherapy using the conventional Rotisserie method with the non-Rotisserie method. Afr J Urol. 2023;29:54.
https://link.springer.com/article/10.1186/s12301-023-00375-1
Spencer BA, McBride RB, Hershman DL, et al. Adjuvant intravesical bacillus calmette-guerin therapy and survival among elderly patients with non-muscle-invasive bladder cancer. J Oncol Pract/ Am Soc Clin Onc. 2013;9:92–8.
http://www.jop.ascopubs.org/content/9/2/92.short
Lim D, Izawa JI, Middlebrook P, et al. Bladder perforation after immediate postoperative intravesical instillation of mitomycin C. Can Urol Assoc J. 2010;4:E1–3.
http://www.ncbi.nlm.nih.gov/pubmed/20174483
Akbulut Z, Canda AE, Atmaca AF, et al. BCG sepsis following inadvertent intravenous BCG administration for the treatment of bladder cancer can be effectively cured with anti-tuberculosis medications. N Z Med J. 2010;123:72–7.
http://www.ncbi.nlm.nih.gov/pubmed/21317964
Kamel AIa. Low dose BCG regimen in T1 transitional cell carcinoma of the bladder: long term results. J Egypt Natl Canc Inst. 2009;21:151–5.
http://www.ncbi.nlm.nih.gov/pubmed/21057566
Geng V, Lurvink H, Pearce I, et al. Catheterisation, Indwelling catheterisation in adults, Urethral and Suprapubic – Evidence-based Guidelines for Best Practice in Urological Health Care. 1st ed: EAUN Office; 2024.
https://nurses.uroweb.org/guidelines/indwelling-catheterisation-in-adults-urethral-and-suprapubic
Pugliese JM, Greene RN, Peterson AC. Intravesical therapy use in the high risk patient: practice patterns in an equal access healthcare institution before and after national guidelines. Can J Urol. 2009;16:4927–31.
http://www.ncbi.nlm.nih.gov/pubmed/20003671
Cindolo L, Palmieri EA, Autorino R, et al. Standard versus hydrophilic catheterization in the adjuvant treatment of patients with superficial bladder cancer. Urol Int. 2004;73:19–22.
http://www.ncbi.nlm.nih.gov/pubmed/15263787
Hedlund H, Hjelms K, Jonsson O, et al. Hydrophilic versus non-coated catheters for intermittent catheterization. Scand J Urol Nephrol. 2001;35:49–53.
http://www.ncbi.nlm.nih.gov/pubmed/11291688
De Ridder DJMK, Everaert K,Fernández LG, et al. Intermittent catheterisation with hydrophilic-coated catheters (SpeediCath) reduces the risk of clinical urinary tract infection in spinal cord injured patients: a prospective randomised parallel comparative trial. Eur Urol. 2005;48:991–5.
http://www.ncbi.nlm.nih.gov/pubmed/16137822
Loertzer H, Brake M, Horsch R, et al. Do bacteriostatic urethral lubricants affect the clinical efficacy of intravesical bacillus Calmette-Guerin therapy? Urology. 2001;57:900–5.
www.ncbi.nlm.nih.gov/pubmed/11337290
Serretta V. Optimizing intravesical chemotherapy in patient with non muscle invasive bladder carcinoma. Arch Ital Urol Androl. 2008;80:143–8.
http://www.ncbi.nlm.nih.gov/pubmed/19235430
De Bruijn EA SH, van Helsdingen PJ, et al. Pharmacodynamics and pharmacokinetics of intravesical mitomycin C upon different dwelling times. Int J Cancer. 1992;51:359–64.
http://www.ncbi.nlm.nih.gov/pubmed/1592527
Burger M, Oosterlinck W, Konety B, et al. ICUD-EAU international consultation on bladder cancer 2012: Non-muscle-invasive urothelial carcinoma of the bladder. Eur Urol. 2013;63:36–44.
http://www.ncbi.nlm.nih.gov/pubmed/22981672
Kaasinen E, Rintala E, Hellstrom P, et al. Factors explaining recurrence in patients undergoing chemoimmunotherapy regimens for frequently recurring superficial bladder carcinoma. Eur Urol. 2002;42:167–74.
http://www.ncbi.nlm.nih.gov/pubmed/12160589
Wang W, Chen Y, Gu J. Effectiveness of integrated nursing interventions in enhancing patient outcomes during postoperative intravesical instillation for non-muscle invasive bladder cancer: A comparative study. Medicine (Baltimore). 2024;103:e36871.
https://pubmed.ncbi.nlm.nih.gov/38489732/
Griffin JG, Holzbeierlein J. Side Effects of Perioperative Intravesical Treatment and Treatment Strategies for These Side Effects. Urol Clin North Am. 2013;40:197––210
http://www.ncbi.nlm.nih.gov/pubmed/23540778
Au JL, Badalament RA, Wientjes MG, et al. Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III trial. J Natl Cancer Inst. 2001;93:597–604.
http://www.ncbi.nlm.nih.gov/pubmed/11309436
Kapoor R, Vijjan V, Singh P. Bacillus Calmette-Guerin in the management of superficial bladder cancer. Indian J Urol. 2008;24:72–6.
https://pubmed.ncbi.nlm.nih.gov/19468364/
Katz G, Hackett RL, Wajsman Z. Bladder wall fibrosis following intravesical mitomycin treatment for superficial bladder cancer. Urology. 1996;47:928–9.
http://www.ncbi.nlm.nih.gov/pubmed/8677595
Thrasher JB, Crawford ED. Complications of intravesical chemotherapy. Urol Clin North Am. 1992;19:529–39.
http://www.ncbi.nlm.nih.gov/pubmed/1636237
Drago PC, Badalament RA, Lucas J, et al. Bladder wall calcification after intravesical mitomycin C treatment of superficial bladder cancer. J Urol. 1989;142:1071–2.
http://www.ncbi.nlm.nih.gov/pubmed/2507794
Inglis JA, Tolley DA, Grigor KM. Allergy to mitomycin C complicating topical administration for urothelial cancer. BJU Int. 1987;59:547–9.
http://www.ncbi.nlm.nih.gov/pubmed/3120846
Wajsman Z, McGill W, Englander L. Severely contracted bladder following intravesical mitomycin C therapy. J Urol. 1983;130:340–1.
http://www.ncbi.nlm.nih.gov/pubmed/6410085
Bosschieter J, Nieuwenhuijzen JA, van Ginkel T, et al. Value of an Immediate Intravesical Instillation of Mitomycin C in Patients with Non-muscle-invasive Bladder Cancer: A Prospective Multicentre Randomised Study in 2243 patients. Eur Urol. 2018;73:226–32.
https://pubmed.ncbi.nlm.nih.gov/28705539/
Fiore AA, Iorio B, Vennarecci G, et al. Papillary-like bladder calcifications following intravesical mitomycin C. A case report. Minerva Urol Nefrol. 1993;45:171–3.
http://www.ncbi.nlm.nih.gov/pubmed/8023227
Llopis M, Moreno J, Botella R, et al. Incrusted cystitis after intravesical mitomycin C treatment. Acta Urol Belg. 1993;61:21–3.
http://www.ncbi.nlm.nih.gov/pubmed/8256682
De Groot AC, Conemans JMH. Systemic allergic contact dermatitis from intravesical instillation of the antitumor antibiotic mitomycin C. Contact Dermat. 1991;24:201–9.
http://www.ncbi.nlm.nih.gov/pubmed/1831098
Arregui MA, Aguirre A, Gil N, et al. Dermatitis due to mitomycin C bladder instillations: Study of 2 cases. Contact Dermat. 1991;24:368–70.
http://www.ncbi.nlm.nih.gov/pubmed/1832619
Eijsten A, Knonagel H, Hotz E, et al. Reduced bladder capacity in patients receiving intravesical chemoprophylaxis with mitomycin C. BJU Int. 1990;66:386–8.
https://pubmed.ncbi.nlm.nih.gov/2121309/
Baker WC, Russo MA, deVere White RW. Severe bladder contracture in patient receiving intravesical mitomyin C for superficial bladder cancer. Urology. 1987;30:357–8.
http://www.ncbi.nlm.nih.gov/pubmed/3116739
Stoehr B, Mueller T, Granig T, et al. Increasing patient comfort by optimized postoperative administration of intravesical mitomycin C. BJU Int 2008;102:1556–9.
http://www.ncbi.nlm.nih.gov/pubmed/18691179
Mertens LS, Meinhardt W, Rier WB, et al. Extravasation of intravesical chemotherapy for non-muscle-invasive bladder cancer. Urol Int. 2012;89:332–6.
http://www.ncbi.nlm.nih.gov/pubmed/22965138
Wilson JRF, Turney BW, LeMonnier K, et al. A comparison of two BCG instillation regimens for non-muscle invasive bladder cancer: A retrospective cohort analysis of side effect profiles. BJU Int 2010;3:241–8.
https://www.sciencedirect.com/science/article/abs/pii/S1875974210000431
Bohle A, Jocham D, Bock PR. Intravesical bacillus Calmette-Guerin versus mitomycin C for superficial bladder cancer: a formal meta-analysis of comparative studies on recurrence and toxicity. J Urol. 2003;169:90–5.
https://www.ncbi.nlm.nih.gov/pubmed/12478111
Van der Meijden APM, Sylvester R, Oosterlinck W, et al. Maintenance Bacillus Calmette-Guerin for Ta T1 bladder tumors is not associated with increased toxicity: results from a European Organisation for Research and Treatment of Cancer Genito-Urinary Group Phase III Trial. Eur Urol. 2003;44:429–4.
http://www.ncbi.nlm.nih.gov/pubmed/14499676
Witjes JA PJ, Soloway M, et al. Clinical practice recommendations for the prevention and management of intravesical therapy-associated adverse events. Eur Urol Suppl. 2008;7:667–74.
http://www.europeanurology.com/article/S1569-9056(08)00110-3/abstract
Palou J, Rodriguez-Villamil L, Andreu-Crespo A, Salvador-Bayarri J, Vicente-Rodriguez. J. Intravesical treatment of severe bacillus Calmette-Guerin cystitis. Int Urol Nephrol. 2001;33:485–9.
https://www.ncbi.nlm.nih.gov/pubmed/12230277
Falkensammer C, Gozzi C, Hager M, et al. Late occurrence of bilateral tuberculous-like epididymo-orchitis after intravesical bacille Calmette-Guerin therapy for superficial bladder carcinoma. Urology. 2005;65:175.
https://www.ncbi.nlm.nih.gov/pubmed/15667898
Tinazzi E, Ficarra V, Simeoni S, et al. Reactive arthritis following BCG immunotherapy for urinary bladder carcinoma: a systematic review. Rheumatol int. 2006;26:481–8.
https://www.ncbi.nlm.nih.gov/pubmed/16220289
European Medicines Agency. Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics.
https://www.ema.europa.eu/en/medicines/human/referrals/quinolone-fluoroquinolone-containing-medicinal-products
Chowdhury AR, Dey RK. Penile tuberculosis following intravesical Bacille Calmette-Guerin immunotherapy. Indian J Urol. 2013;29:64–6.
http://www.ncbi.nlm.nih.gov/pubmed/23671370
Lestre SIA, Gameiro CD, Joao A, et al. Granulomas of the penis: a rare complication of intravesical therapy with Bacillus Calmette-Guerin. An Bras Dermatol. 2011;86:759–62.
http://www.ncbi.nlm.nih.gov/pubmed/21987145
French CG, Hickey L, Bell DG. Caseating granulomas on the glans penis as a complication of bacille calmette-guerin intravesical therapy. Rev Urol. 2001;3:36–8.
http://www.ncbi.nlm.nih.gov/pubmed/16985688
Cheung JMK, Hou SSM, Yip SKH, et al. An unusual cause of retention of urine after intravesical bacillus calmette-guerin therapy for superficial bladder cancer. Hong Kong Med J. 2011;17:492–4.
https://pubmed.ncbi.nlm.nih.gov/22147321/
Galvan L, Ayani I, Arrizabalaga MJ, et al. Intravesical BCG therapy of superficial bladder cancer: Study of adverse effects. J Clin Pharm Ther. 1994;19:101–4.
http://www.ncbi.nlm.nih.gov/pubmed/8071388
Lamm DLa. Incidence and treatment of complications of bacillus Calmette-Guerin intravesical therapy in superficial bladder cancer. J Urol. 1992;147:596–600.
http://www.ncbi.nlm.nih.gov/pubmed/1538436
Witjes JA, Palou J, Soloway M, et al. Clinical Practice Recommendations for the Prevention and Management of Intravesical Therapy–Associated Adverse Events. Eur Urol Suppl. 2008;7:667–74.
https://www.sciencedirect.com/science/article/abs/pii/S1569905608001103
Schreinemachers LMHa. Intravesical and intradermal Bacillus Calmette-Guerin application. A phase I study to the toxicity of a Dutch Bacillus Calmette-Guerin preparation in patients with superficial bladder cancer. Eur Urol. 1988;14:15–21.
http://www.ncbi.nlm.nih.gov/pubmed/2963745
Lowther C, Miedler JD, Cockerell CJ. Id-like reaction to BCG therapy for bladder cancer. Cutis. 2013;91:145–51.
http://www.ncbi.nlm.nih.gov/pubmed/23617086
Orihuela E, Herr HW, Pinsky CM, et al. Toxicity of intravesical BCG and its management in patients with superficial bladder tumors. Cancer. 1987;60:326–33.
http://www.ncbi.nlm.nih.gov/pubmed/3594369
Linn R, Klimberg IW, Wajsman Z. Persistent acid-fast bacilli following intravesical bacillus Calmette-Guerin. J Urol. 1989;141:1197–8.
http://www.ncbi.nlm.nih.gov/pubmed/2709508
Strock V, Dotevall L, Sandberg T, C.K G, S H. Late bacille Calmette-Guerin infection with a large focal urinary bladder ulceration as a complication of bladder cancer treatment. BJU Int. 2011;107:1592–7.
http://www.ncbi.nlm.nih.gov/pubmed/21166754
Spirnak JP, Lubke WL, Thompson IM, et al. Dystrophic bladder wall calcifications following intravesical BCG treatment for superficial transitional cell carcinoma of bladder. Urology. 1993;42:89–92.
https://pubmed.ncbi.nlm.nih.gov/8328131/
Suzuki S, Shinohara N, Harabayashi T, et al. Complications of bacillus Calmette-Guerin therapy in superficial urothelial cancer: Clinical analysis and implications. Int J Clin Oncol. 2002;7:289–93.
http://www.ncbi.nlm.nih.gov/pubmed/12402062
Costiniuk CT, Sharapov AA, Rose GW, et al. Mycobacterium bovis abdominal aortic and femoral artery aneurysms following intravesical bacillus Calmette-Guerin therapy for bladder cancer. Cardiovasc Pathol. 2010;19:e29–e32.
http://www.ncbi.nlm.nih.gov/pubmed/19026573
Vegt PDJa. 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;157:1246–9.
http://www.ncbi.nlm.nih.gov/pubmed/9120912
Martinez-Caceres P, Rubio-Briones J, Palou J, et al. Prevesical and inguinal abscess following intravesical BCG instillation. Scand J Urol Nephrol. 1998;32:409–10.
http://www.ncbi.nlm.nih.gov/pubmed/9925006
Gonzalez JA, Marcol BR, Wolf MC. Complications of intravesical Bacillus Calmette-Guerin: A case report. J Urol. 1992;148:1892–3.
https://pubmed.ncbi.nlm.nih.gov/1433632/
Holmes BJ, LaRue RW, Black JH, 3rd, et al. Mycotic aortic aneurysm due to intravesical BCG immunotherapy: Clinical manifestations and diagnostic challenges. Int J Mycobacteriol. 2014;3:60–5.
https://pubmed.ncbi.nlm.nih.gov/26786225/
Lorenzo JF, López Arquillo IM, Rey JV. Primary aortoenteric fistula after intravesical instillation of Bacillus Calmette-Guérin for bladder cancer. Vascular. 2023;32:952–6.
https://pubmed.ncbi.nlm.nih.gov/37148206/
Senes AT, Badet L, Lyonnet D, et al. Granulomatous renal masses following intravesical bacillus Calmette Guerin therapy: the central unaffected calyx sign. Br J Radiol. 2007;80:e230–3.
http://www.ncbi.nlm.nih.gov/pubmed/17959911
Garcia JE, Thiel DD, Broderick GA. BCG pyelonephritis following intravesical therapy for transitional cell carcinoma. Can J Urol. 2007;14:3523–5.
http://www.ncbi.nlm.nih.gov/pubmed/17466161
Abdullah OD, Kamran A, Fozia N, et al. Frequency of Complications Post-Intravesical BCG Instillation in Patients with Superficial Urinary Bladder Carcinoma. Pak J Med Health Sci. 2022;16:293.
https://pjmhsonline.com/index.php/pjmhs/article/view/1982
Anis O, Yogev D, Dotan A, et al. Autoimmune disorders caused by intravesical bacillus Calmette-Guerine treatment: A systematic review. Autoimmun Rev. 2023;22:103329.
https://pubmed.ncbi.nlm.nih.gov/37061015/
Witjes JA, Vriesema JLJ, Brinkman K, et al. Mycotic aneurysm of the popliteal artery as a complication of intravesical BCG therapy for superficial bladder cancer: Case report and literature review. Urol Int 2003;71:430–2.
https://pubmed.ncbi.nlm.nih.gov/14646447/
Damm O, Briheim G, Hagstrom T, et al. Ruptured mycotic aneurysm of the abdominal aorta: A serious complication of intravesical instillation bacillus Calmette-Guerin therapy. J Urol. 998;159:984.
http://www.ncbi.nlm.nih.gov/pubmed/9474201
Nam EY, Na SH, Kim SY, et al. Infected Aortic Aneurysm caused by Mycobacterium bovis after Intravesical Bacillus Calmette-Guérin Treatment for Bladder Cancer. Infect Chemother. 2015;47:256–60.
https://pubmed.ncbi.nlm.nih.gov/26788410/
Matsuoka Y, Taoka R, Kohashiguchi K, et al. Efficacy and toxicity of intravesical Bacillus Calmette-Guérin therapy in elderly patients with non-muscle-invasive bladder cancer. Curr Urol 2021;15.
https://pubmed.ncbi.nlm.nih.gov/34084117/
Jose Manzanera Escribano M MRE, Odriozola Grijalba M, et al. Acute renal failure due to interstitial nephritis after intravesical instillation of BCG. Clin Exp Nephrol. 2007;11:238–40.
http://www.ncbi.nlm.nih.gov/pubmed/17891353
Gao CQ, Mithani R, Leya J, Dawravoo L, et al. Granulomatous hepatitis, choroiditis and aortoduodenal fistula complicating intravesical Bacillus Calmette-Guerin therapy: Case report. BMC Infect Dis. 2011;11.
http://www.ncbi.nlm.nih.gov/pubmed/21961922
Ozbakkaloglu B, Tunger O, Surucuoglu S, et al. Granulomatous hepatitis following intravesical bacillus Calmette-Guerin therapy. Int Urol Nephrol. 1999;31:49–53.
http://www.ncbi.nlm.nih.gov/pubmed/10408303
Geldmacher H, Taube C, Markert U, et al. Nearly fatal complications of cervical lymphadenitis following BCG immunotherapy for superficial bladder cancer. Respiration. 2001;68:420–1.
http://www.ncbi.nlm.nih.gov/pubmed/11464093
Pancaldi P, Van Linthoudt D, Alborino D, et al. Reiter’s syndrome after intravesical Bacillus Calmette-Guerin treatment for superficial bladder carcinoma. Br J Rheumatol. 1993;32:1096–8.
http://www.ncbi.nlm.nih.gov/pubmed/8252321
Josephson CB, Al-Azri S, Smyth DJ, et al. A case of Pott’s disease with epidural abscess and probable cerebral tuberculoma following Bacillus Calmette-Guerin therapy for superficial bladder cancer. Can J Infect Dis Med Microbiol. 2010;21:e75–e8.
https://pubmed.ncbi.nlm.nih.gov/21358881/
Agrawal MS, Agrawal M, Bansal S, et al. The Safety and Efficacy of Different Doses of Bacillus Calmette Guerin in Superficial Bladder Transitional Cell Carcinoma. Urology. 2007;70:1075–8.
http://www.ncbi.nlm.nih.gov/pubmed/18158020
Miyazaki M, Yoshiiwa T, Ishihara T, et al. Tuberculous Spondylitis following Intravesical Bacillus Calmette-Guerin for Bladder Cancer. Case Rep Orthop. 2016;2016:6741284.
https://pubmed.ncbi.nlm.nih.gov/27313927/
Topazio L, Miano R, Maurelli V, et al. Could hyaluronic acid (HA) reduce Bacillus Calmette-Guérin (BCG) local side effects? Results of a pilot study. BMC Urol. 2014;14:64.
https://pubmed.ncbi.nlm.nih.gov/25123116/
Canepa G, Campodonico F, Tamagno S, et al. Adelmidrol + hyaluronic acid in the treatment of symptoms associated with intravesical anticancer therapy in non-muscle invasive bladder cancer. An observational retrospective investigation. Pelviperineology. 2023;42:5–11.
https://pelviperineology.org/articles/adelmidrol-hyaluronic-acid-in-the-treatment-of-symptoms-associated-with-intravesical-anticancer-therapy-in-non-muscle-invasive-bladder-cancer-an-observational-retrospective-investigation/PPj.2023.42.01.2023-1-2
Imperatore V, Creta M, Di Meo S, et al. Intravesical administration of combined hyaluronic acid and chondroitin sulfate can improve symptoms in patients with refractory bacillus Calmette-Guerin-induced chemical cystitis: Preliminary experience with one-year follow-up. Arch Ital Urol Androl. 2018;90:11–4.
https://pubmed.ncbi.nlm.nih.gov/29633792/
Gubbiotti M, Rubilotta E, Bacchiani M, et al. Intravesical administration of highly concentrated hyaluronic acid and chondroitin sulfate as add-on therapy for chemical cystitis induced by Bacillus Calmette-Guérin (BCG) immunotherapy. Int Urol Nephrol. 2025;57:2033–9.
https://pubmed.ncbi.nlm.nih.gov/39821149/
Numakura K, Kobayashi M, Ishida T, et al. Effect of Levofloxacin on the Efficacy and Adverse Events in Intravesical Bacillus Calmette-Guerin Treatment for Bladder Cancer: Results of a Randomized, Prospective, Multicenter Study. Eur Urol Focus. 2022;8:1666–72.
https://pubmed.ncbi.nlm.nih.gov/35717522/
Damiano R, De Sio M, Quarto G, et al. Short-term administration of prulifloxacin in patients with nonmuscle-invasive bladder cancer: an effective option for the prevention of bacillus Calmette-Guerin-induced toxicity? BJU Int. 2009;104:633–9.
https://www.ncbi.nlm.nih.gov/pubmed/19298412
Ecclestone H, Hamid R. Intravesical Bacillus Calmette-Guerin Cystitis. Curr Bladder Dysfunct Rep. 2017;12:207–11.
https://link.springer.com/article/10.1007/s11884-017-0437-0
Koch GE, Smelser WW, Chang SS. Side Effects of Intravesical BCG and Chemotherapy for Bladder Cancer: What They Are and How to Manage Them. Urology. 2021;149:11–20.
https://pubmed.ncbi.nlm.nih.gov/33181123/
Nouhaud FX, Rigaud J, Saint F, et al. Final results of the phase III URO-BCG 4 multicenter study: efficacy and tolerance of one-third dose BCG maintenance in nonmuscle invasive bladder cancer. Anticancer Drugs. 2017;28:335–40.
https://pubmed.ncbi.nlm.nih.gov/27902496/
Danielsson G, Thiel T, Thulin H. Bladder Instillation Therapy Form (BITF)—Nursing Instrument for Intravesical Bacillus Calmette-Guérin Instillations. Int J Urol Nurs. 2025;19.
https://onlinelibrary.wiley.com/doi/10.1111/ijun.70037
Catto JWF, Downing A, Mason S, et al. Quality of Life After Bladder Cancer: A Cross-sectional Survey of Patient-reported Outcomes. Eur Urol. 2021;79:621–32.
https://pubmed.ncbi.nlm.nih.gov/33581875/
Kopenhafer L, Thompson A, Chang J, et al. Patient experience and unmet needs in high-risk nonmuscle-invasive bladder cancer: Insights from qualitative interviews and a cross-sectional survey. Urol Oncol. 2024;42:70.e1–.e10.
https://pubmed.ncbi.nlm.nih.gov/38272755/
Rammant E, Fox L, Beyer K, et al. The current use of the EORTC QLQ-NMIBC24 and QLQ-BLM30 questionnaires for the assessment of health-related quality of life in bladder cancer patients: a systematic review. Qual Life Res. 2023;32:2127–35.
https://www.ncbi.nlm.nih.gov/pubmed/36648569
Witjes JA. Follow-up in non-muscle invasive bladder cancer: facts and future. World J Urol. 2021;39:4047–53.
https://pubmed.ncbi.nlm.nih.gov/33367941/
Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–76.
http://www.ncbi.nlm.nih.gov/pubmed/8433390
World Health Organization. WHOQOL User Manual - Programme on mental health 2012
https://www.who.int/tools/whoqol
Lee LJ, Kwon CS, Forsythe A, et al. Humanistic and Economic Burden of Non-Muscle Invasive Bladder Cancer: Results of Two Systematic Literature Reviews. Clinicoecon Outcomes Res. 2020;12:693–709.
https://pubmed.ncbi.nlm.nih.gov/33262624/
Vaioulis A, Bonotis K, Perivoliotis K, et al. Quality of Life and Anxiety in Patients with First Diagnosed Non-Muscle Invasive Bladder Cancer Who Receive Adjuvant Bladder Therapy. Bladder Cancer. 2021;7:297–306.
https://pubmed.ncbi.nlm.nih.gov/38993613/
Siracusano S, Silvestri T, Bassi S, et al. Health-related quality of life after BCG or MMC induction for non-muscle invasive bladder cancer. Can J Urol. 2018;25:9480–5.
https://pubmed.ncbi.nlm.nih.gov/30281005/
Yuen JW, Wu RW, Ching SS, et al. Impact of Effective Intravesical Therapies on Quality of Life in Patients with Non-Muscle Invasive Bladder Cancer: A Systematic Review. Int J Environ Res Public Health. 2022;19.
https://pubmed.ncbi.nlm.nih.gov/36078542/
van Straten C, Caris C, Grimm MO, et al. Quality of Life in Patients with High-grade Non-muscle-invasive Bladder Cancer Undergoing Standard Versus Reduced Frequency of Bacillus Calmette-Guérin Instillations: The EAU-RF NIMBUS Trial. Eur Urol Open Sci. 2023;56:15–24.
https://pubmed.ncbi.nlm.nih.gov/37822514/
Grabe-Heyne K, Henne C, Mariappan P, et al. Intermediate and high-risk non-muscle-invasive bladder cancer: an overview of epidemiology, burden, and unmet needs. Front Oncol. 2023;13:1170124.
https://pubmed.ncbi.nlm.nih.gov/37333804/
Beeren I, Klerks NE, Aben KK, Oddens JR, Witjes JA, Kiemeney LA, et al. Health-related Quality of Life During the First 4 Years After Non-Muscle-invasive Bladder Cancer Diagnosis: Results of a Large Multicentre Prospective Cohort. Eur Urol Oncol. 2024;7:829–37.
https://pubmed.ncbi.nlm.nih.gov/37996278/
Koga H, Ozono S, Tsushima T, Tomita K, et al. Maintenance intravesical bacillus Calmette-Guérin instillation for Ta, T1 cancer and carcinoma in situ of the bladder: randomized controlled trial by the BCG Tokyo Strain Study Group. Int J Urol. 2010;17:759–66.
http://www.ncbi.nlm.nih.gov/pubmed/20604814
Beeren I, Koops C, van der Heijden AG, et al. Lifestyle Advice to Patients with Bladder Cancer: A National Survey of Dutch Urologists. Bladder Cancer. 2024;10:215–20.
https://pubmed.ncbi.nlm.nih.gov/39493821/
Sandager M, Freil, M, Knudsen JL. Please tick the appropriate box: perspectives on patient reported experience. Patient Exp J. 2016;3 (1):63–79.
https://pxjournal.org/journal/vol3/iss1/10/
Myers A, Ristau B, Mossanen M, et al. Patient reported treatment burden and attitudes towards in-home intravesical therapy among patients with bladder cancer. Urol Oncol. 2024;42:29.e17–29.e2.
https://pubmed.ncbi.nlm.nih.gov/37993341/
Rutherford C, Costa DSJ, King MT, et al. A conceptual framework for patient-reported outcomes in non-muscle invasive bladder cancer. Support Care Cancer. 2017;25:3095–102.
https://pubmed.ncbi.nlm.nih.gov/28451912/
Alcorn J, Burton R, Topping A. Withdrawing from treatment for Bladder cancer: Patient experiences of BCG installations. Int J Urol Nurs. 2020;14.
https://onlinelibrary.wiley.com/doi/abs/10.1111/ijun.12236
Chung J, Kulkarni GS, Morash R, et al. Assessment of quality of life, information, and supportive care needs in patients with muscle and non-muscle invasive bladder cancer across the illness trajectory. Support Care Cancer. 2019;27:3877–85.
https://pubmed.ncbi.nlm.nih.gov/30767131/
Miyake M, Nishimura N, Oda Y, et al. Intravesical Bacillus Calmette-Guerin treatment-induced sleep quality deterioration in patients with non-muscle invasive bladder cancer: functional outcome assessment based on a questionnaire survey and actigraphy. Support Care Cancer. 2022;30:887–95.
https://pubmed.ncbi.nlm.nih.gov/34398288/

Appendix 3

Example of side effects questionnaire