INVOKANA - Adverse Event - Urinary Tract Infections

Summary

• A post hoc analysis of the CREDENCE study found that INVOKANA increased the risk of genital mycotic infections (GMIs), but not urinary tract infections (UTIs). INVOKANA did not affect the risk of UTI overall or in any subgroup.¹
• In the CANVAS trial^2,3, one of two trials^2-5 comprising the CANVAS Program, UTI adverse events (AEs) were reported at an incidence rate (IR) of 40 and 37 per 1000 patients-years in the INVOKANA and placebo treatment groups, respectively.⁶
• Pooled Phase 3, Placebo-Controlled Studies:
  • In the pool of four 26-week placebo-controlled clinical trials^7-10, UTI was a commonly reported adverse reaction (≥2%): INVOKANA 100 mg (5.9%), INVOKANA 300 mg (4.3%) and placebo (4%).¹¹
    • Recurrence: Recurrent symptomatic UTI was similar across INVOKANA and non-INVOKANA treatment groups.¹¹
    • Discontinuation: Discontinuations due to UTIs occurred in 0.2%, 0.1%, and 0% of patients in the placebo, INVOKANA 100 mg, and 300 treatment groups, respectively.¹¹
    • Treatment: A slightly higher proportion of subjects in the placebo group (84.6%) compared to the INVOKANA 100 and 300 mg groups (75.5% and 80.6%, respectively) were treated with antimicrobial therapy.¹¹ The specific antimicrobial agents used to treat the UTIs were not reported.
  • Doi et al (2026)¹² conducted a post hoc pooled analysis of the CANVAS and CREDENCE trials to evaluate urine leukocyte esterase (LE) and nitrite (NIT) as predictors of UTI risk. For first UTI events, the hazard ratio (HR) for INVOKANA vs placebo was 1.07 (95% confidence interval [CI], 0.93-1.22). For total UTI events (first+recurrent), the HR was 1.01 (95% CI, 0.86-1.17) for the incidence and distribution of recurrent episodes. UTI-related drug withdrawal occurred in 2.9% (27/942) of INVOKANA-treated patients and 2.1% (13/619) of placebo-treated patients.
  • Nguyen et al (2025)¹³ conducted a post hoc individual patient-level pooled analysis of the CANVAS Program and CREDENCE trial to evaluate the association between frailty and outcomes in patients treated with INVOKANA. For UTIs, the HR for INVOKANA vs placebo was 1.09 (95% CI, 0.96-1.24) overall, 1.001
    (95% CI, 0.85-1.18) in frail patients, and 1.26 (95% CI, 1.02-1.56) in nonfrail patients.
  • Siriwardana et al (2025)¹⁴ conducted a post hoc pooled analysis of the CANVAS Program and CREDENCE trial to evaluate the efficacy and safety of INVOKANA across age groups and cardiorenal risk profiles. For serious UTIs, events were reported in 65/7990 patients receiving INVOKANA and 51/6541 patients receiving placebo, corresponding to an HR of 0.98 (95% CI, 0.68-1.43). The HRs for serious UTIs were 0.83 (95% CI, 0.47-1.48) among patients aged <65 years, 0.89 (95% CI, 0.5-1.58) among those aged 65 to <75 years, and 2.07 (95% CI, 0.78-5.49) among those aged ≥75 years; the P_trend across age groups was 0.32.
  • Cardoza et al (2024)^15,16 conducted a post hoc analysis of the CREDENCE trial to evaluate kidney, cardiovascular (CV), and safety outcomes across geographic regions and racial groups. For UTIs by geographic region, events occurred in 245/2200 patients receiving INVOKANA and 221/2197 patients receiving placebo, with IRs of 51.3 and 47.9 events per 100 patient-years, respectively (HR, 1.08; 95% CI, 0.901.29; P_interaction=0.81). For UTIs by race, events occurred in 245/2200 patients receiving INVOKANA and 221/2197 patients receiving placebo, with IRs of 51.3 and 47.9 events per 100 patient-years, respectively (HR, 1.08;95% CI, 0.9-1.29; P_interaction=0.87).
• Pooled Phase 3, Placebo- and Active-Controlled Studies: In a pooled dataset of eight phase 3 active- and placebo-controlled studies^2,7-10,17-19 with longer mean exposure, the incidence of UTI AEs was 8.2%, 8.1%, and 6.7% with INVOKANA 100 mg, INVOKANA 300 mg, and non-INVOKANA, respectively.¹¹
• Please find in the REFERENCES section: Incidence of UTI with INVOKANA treatment was also reported in other phase 3 and postmarketing studies.^20-24 Published systematic reviews and meta-analyses support the above phase 2/3 AE data related to INVOKANA use.^25-27 The economic impact of UTI in patients treated with INVOKANA was evaluated in a retrospective cohort study.²⁸

PHASE 3 STUDIES

CREDENCE

CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven study designed to assess effects of INVOKANA (100 mg once daily) vs placebo on clinically important renal outcomes in patients with type 2 diabetes mellitus (T2DM) and established chronic kidney disease (estimated glomerular filtration rate [eGFR] 30 to <90 mL/min/1.73 m²) and albuminuria (urinary albumin to creatinine ratio >300 to 5000 mg/g), who were receiving a stable, maximum tolerated labelled dose (for ≥4 weeks prior to randomization) of an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker.^29-33 In a post hoc analysis of CREDENCE, Kang et al (2020)¹ analyzed the risk of GMI and UTI with INVOKANA compared to placebo, both overall and in subgroups, in addition to predictors of risk for GMIs.

• The primary analysis was conducted in the on-treatment population.
• Overall, 5.7% (166/2905) of men and 20.1% (300/1492) of women experienced 669 UTIs, of which 8.7% (58/669) were reported as serious. The majority of patients continued treatment following their first infection, with similar recurrence rates in the INVOKANA and placebo groups.
• INVOKANA did not affect the risk of UTI (HR, 1.08; 95% CI, 0.90-1.29; P=0.42) overall or in any subgroup.

CANVAS Program

The CANVAS Program (N=10,142) was comprised of 2 large INVOKANA CV outcome studies, including CANVAS and CANVAS-R.⁶ The CANVAS Program includes a pre-specified integrated analysis of the two trials designed to meet FDA post-marketing requirement to determine CV safety, as well as evaluate the potential for CV protection efficacy of INVOKANA in patients with T2DM.^3-5,34 The mean duration of diabetes at baseline was 13.5 years (13.5 years in INVOKANA treatment group; 13.7 years in the placebo group).⁶

• In the CANVAS Program, UTIs were identified as an AE of interest which required the collection of additional information for a more detailed analysis.³⁵
• UTI events in the CANVAS trial were reported at an IR of 40 and 37 per 1000 patients-years in the INVOKANA and placebo treatment groups, respectively (P=0.38).⁶
  • (Note: The annualized IRs of UTI are reported with data from CANVAS alone through 7 January 2014, because after this time, only serious AEs or AEs leading to discontinuation were collected. In CANVAS-R, only serious AEs or AEs leading to discontinuation were collected. Owing to the differences between the two trials in methods of collection of the data, an integrated analysis of these AEs is not possible.)⁶

Pooled Analysis of Phase 3, Placebo-Controlled Studies

Doi et al (2026)¹² conducted a post hoc pooled analysis of individual participant data from the CANVAS and CREDENCE trials to assess whether urine dipstick LE and NIT findings predicted UTI risk and modified the effect of INVOKANA on UTI outcomes.

• Among the 8614 patients included in the analysis, 34.8% were female, the mean age was 62 years, and the median follow-up was 2.8 years (interquartile range [IQR], 1.9-4.1) for the on-treatment UTI analysis.
• INVOKANA did not significantly affect the risk of first UTI events in the overall population (HR, 1.07; 95% CI, 0.93-1.22). For total UTI events, the incidence and distribution of recurrent episodes were comparable between the INVOKANA and placebo treatment groups (HR, 1.01; 95% CI, 0.86-1.17).
• UTI events leading to drug withdrawal were comparable between the treatment groups, occurring in 2.9% (27/942) of INVOKANA-treated patients and 2.1% (13/619) of placebo-treated patients. Mixed-effects logistic regression analyses showed no significant effect of INVOKANA on longitudinal LE results (odds ratio [OR], 1.02; 95% CI, 0.84-1.24) or NIT results (OR, 0.87; 95% CI, 0.66-1.14).
• Effect-modification analyses were conducted using LE categories (normal, 1-2+, and 3+) and a binary classification (normal vs abnormal), while NIT was analyzed using a binary classification.
  • For first UTI events, LE did not modify the effect of INVOKANA in either the three-category or binary analyses (P_interaction=0.20 and 0.10, respectively), and no effect modification was observed with NIT (P_interaction=0.45).
  • In the binary analysis, the HR for INVOKANA vs placebo was 1.17 (95% CI, 1-1.38) in the LE-normal group and 0.94 (95% CI, 0.73-1.21) in the LE-abnormal group. For NIT, the corresponding HRs were 1.08 (95% CI, 0.94-1.24) and 0.92 (95% CI,
    0.59-1.43), respectively.
  • For total UTI events, no heterogeneity was observed across NIT categories (P_interaction=0.38). However, LE significantly modified the treatment effect in both the two- and three-category analyses (both P_interaction<0.01). For total UTIs, INVOKANA was associated with an increased risk in the LE-normal group (HR, 1.24; 95% CI, 1.03-1.49) and a decreased risk in the LE-abnormal group (HR, 0.76; 95% CI,
    0.58-0.99).
  • A sensitivity analysis restricted to the CREDENCE trial yielded results consistent with the primary analysis. Three-way interactions among treatment, LE/NIT category, and sex were not significant for either the primary or secondary outcome (all P_interaction>0.50).

Nguyen et al (2025)¹³ conducted a post hoc individual patient-level analysis of pooled data (N=14,543) from the CANVAS Program (n=10,142) and the CREDENCE trial (n=4401). The study developed a trial Frailty Index, evaluated the association between frailty and adverse outcomes, and assessed the efficacy and safety of INVOKANA according to frailty status. The study population included 8080 frail and 6463 nonfrail patients. The mean age was 63.2 years, and 35.3% of the patients were female.

• For UTI outcomes, the unadjusted HR with INVOKANA was 1.09 (95% CI, 0.96-1.24) in all patients, 1.001 (95% CI, 0.85-1.18) in frail patients, and 1.26 (95% CI, 1.02-1.56) in nonfrail patients; the P_interaction between frailty status and INVOKANA intervention was 0.07.
• Siriwardana et al (2025)¹⁴ conducted a post hoc analysis of individual participant data pooled from the CANVAS Program (CANVAS and CANVAS-R trials) and the CREDENCE trial (N=14,543; CANVAS, n=10,142; CREDENCE, n=4401) to evaluate the efficacy and safety of INVOKANA across a broad range of age and cardiorenal risk. The mean participant age at baseline was 63.7 years (±8.5 years). Overall, 7927 (54.5%) participants were aged <65 years, 5281 (36.3%) were aged 65 to <75 years and 1335 (9.2%) were aged ≥75 years, with the oldest participant aged 90.6 years. The safety outcomes are listed in Table: Safety Outcomes of INVOKANA vs Placebo by Age Group

Cardoza et al (2024)¹⁵ evaluated the effects of INVOKANA on kidney, CV outcomes, and safety outcomes across geographic regions and racial groups using data from the CREDENCE trial. A stratified Cox proportional hazards model was used to evaluate interactions between INVOKANA treatment and geographic region or racial group. The baseline characteristics of the enrolled participants are listed in Table: Baseline Characteristics of Participants in the CREDENCE Trial

Baseline characteristics differed by geographic regions and racial groups. For geographical region, the mean age ranged from 59 years in Asia to 66 years in Western Europe. For racial group, the mean age ranged from 60 years among Asian participants to 64 years among White participants. History of CV disease ranged from 40% in Asia to 71% in Eastern Europe, while it ranged from 44% among White participants to 61% among Asian participants and 65% among participants classified as Other. Table UTI Outcomes by Geographic Region and Table UTI Outcomes by Race describe the effects of INVOKANA on UTI outcomes.

Nicolle et al (2014)¹¹ conducted a pooled analysis of four 26-week, placebo-controlled clinical studies^7-10 (population 1)^5,6. In one trial, INVOKANA was used as monotherapy⁷ and in three trials^8-10, INVOKANA was used as add-on therapy. These data reflect exposure of 1667 patients to INVOKANA and a mean duration of exposure to INVOKANA of 24 weeks. Patients received INVOKANA 100 mg (n=833), INVOKANA 300 mg (n=834) or placebo (n=646) once daily.

• The overall incidence of UTI AEs were 5.9%, 4.3%, and 4% with INVOKANA 100 mg, 300 mg, and placebo, respectively.¹¹
• The majority (88.3%) of subjects with reported UTIs were women.¹¹
  • Women: The incidence of UTIs in the INVOKANA 300 mg group (6.3%) was slightly lower compared with the placebo group (7.7%), with the highest incidence observed in the INVOKANA 100 mg group (11.1%).
  • Men: A similar incidence of UTIs was seen in the placebo (0.6%) and INVOKANA 100 mg (0.5%) groups, with a higher incidence seen in the INVOKANA 300 mg group (2.2%).
• The median time to the first symptomatic UTI was 70.5 and 76 days in the INVOKANA 100 and 300 treatment groups respectively, and 90 days in the placebo group. The median duration of symptomatic UTIs were similar among patients in each group with duration ranging from 11 to 12.5 days.¹¹
• The proportion of patients with recurrent symptomatic UTI was similar across treatment groups: INVOKANA 100 mg (0.6%), INVOKANA 300 mg (0.2%) and placebo (0.5%).¹¹
• Discontinuations due to UTIs occurred in 1 (0.2%) subject in the placebo group, in 1 (0.1%) subject in the INVOKANA 100 mg group and 0% with INVOKANA 300 mg.¹¹
• Severity: Across treatment groups, few serious UTIs were reported: 0%, 0.2% (n=2), and 0.1% (n=1) in the placebo, INVOKANA 100 mg, and INVOKANA 300 mg groups, respectively. Upper UTIs (ie, kidney infection and urosepsis): Two subjects in the INVOKANA groups and no subjects in the placebo group had upper UTIs. Treatment: A slightly higher proportion of subjects in the placebo group (84.6%) compared to the INVOKANA 100 and 300 mg groups (75.5% and 80.6%, respectively) were treated with antimicrobial therapy. The specific antimicrobial agents used to treat the UTIs were not reported.¹¹

Nicolle et al (2014)¹¹ also evaluated UTIs in a pooled dataset of 8 phase 3, active- and placebo-controlled studies^2,7-10,17-19 with longer mean exposure (population 2).

• This population included four 26-week, placebo-controlled studies (population 1)^7-10, an active-controlled study (glimepiride)¹⁷, placebo-controlled studies in patients with moderate renal impairment (eGFR ≥30 and <50 mL/min/1.73m²),¹⁸ and in older patients (≥55 to ≤80 years)¹⁹ and data from the CANVAS study⁶ (data cutoff July 1, 2012).¹¹
• The results of this broader population were generally consistent with those described in population 1. The incidence of UTI AEs were higher with INVOKANA 100 (8.2%) and 300 mg (8.1%) compared to the non- INVOKANA (6.7%) group. For additional information, refer to Table: Summary of UTI AEs in Pooled Data of 8 Active- and Placebo-Controlled Studies.¹¹
• The incidence of upper UTIs (kidney infection, acute and chronic pyelonephritis, urosepsis) were 0.6%, 0.3%, and 0.3% in the INVOKANA 100 mg, INVOKANA 300 mg, and non-INVOKANA treatment groups, respectively. The proportion of patients with acute upper UTIs was similar across treatment groups, however chronic pyelonephritis was reported more in INVOKANA-treated patients (0.13%) than in the non-INVOKANA treatment group (0.03%).¹¹

Additional Phase 3 Data

The incidence of UTIs in the phase 3 study extension periods (up to 52 weeks or 104 weeks) is provided in Tables: Incidence of UTIs in Phase 3, Placebo-/Active-Controlled Studies and Incidence of UTIs in Phase 3, Placebo-Controlled Studies. The overall incidences of UTI AEs in phase 3 studies were similar at the end of the core periods (summarized above) and at the end of the extension periods.

PHASE 2 STUDIES

Rosenstock et al (2012)⁴¹ evaluated the efficacy and safety of INVOKANA in a 12-week, phase 2b, dose-ranging study in adult subjects with T2DM with inadequate glycemic control while on existing metformin monotherapy (N=451).

• Patients were randomized to 1 of 7 groups: INVOKANA 50, 100, 200, or 300 mg once daily, 300 mg twice daily, sitagliptin 100 mg once daily, or placebo.
• Similar rates of UTIs were observed between the INVOKANA (3% to 9%), placebo (6%), and sitagliptin (2%) groups. None of the UTIs led to study discontinuation; they were mild or moderate in severity.
• Additional safety analyses were conducted to determine the prevalence of bacteriuria and frequency of UTIs.⁴²
  • At baseline and at week 12, a midstream, clean-catch urine specimen was used for dipstick analysis and culture. Self-administered vaginal swabs were also obtained.
  • Subjects with a history of a UTI within 3 months prior to screening were excluded.
  • The prevalence of bacteriuria at baseline was 6.4% in the pooled INVOKANA group and 6.5% in the pooled placebo/sitagliptin group (control). This prevalence was higher in women. The number of patients with bacteriuria at week 12 did not differ between the INVOKANA group (7.7%) and the control group (6.3%).
  • Among subjects with negative cultures at baseline, 3 out of 82 (3.7%) control subjects and 10 out of 207 (4.8%) INVOKANA subjects became bacteriuric at week 12, without evidence for dose-dependency in the INVOKANA group. E. coli was the most common organism isolated at baseline and at study end.
  • INVOKANA treatment, relative to placebo/sitagliptin treatment, was not a significant predictor of UTI (after adjusting for other possible risk factors)
    • Adjusted OR, 2.39; 95% CI, 0.58-9.94; P=0.23.

Retrospective analysis

Ahsan et al (2026)⁴³ conducted a retrospective cross-sectional pharmacovigilance study of SGLT2 inhibitor-associated AEs using FAERS data from quarter (Q) 1 2013 to Q4 2024. Among 63,231 individual case safety reports (ICSRs) in which an SGLT2 inhibitor was identified as the primary suspect drug, 28,709 (45.4%) were classified as serious adverse events (SAEs). INVOKANA accounted for 54% of the reported ICSRs. The mean age of patients with INVOKANA-associated ICSRs was 55.67±11.65 years.

• UTI was identified as a SAE associated with SGLT2 inhibitors, with 1153 AE reports and 510 SAE reports. The reporting odds ratio (ROR) was 5.38 (95% CI, 5.07-5.71), proportional reporting ratio (PRR) was 5.3 (95% CI, 5-5.62), and lower bound of the 95% credibility interval for Information Component (IC₀₂₅) was 2.28.
• Among UTI cases reported as SAEs, 436 (2.3%) were associated with hospitalization (n=19,196), 17 (0.3%) with death (n=5803), 28 (1.1%) with life-threatening outcomes (n=2485), and 17 (1.6%) with disability (n=1074).
• Among INVOKANA-associated SAEs (N_SAE=7645), 88 (1.2%) were reported as UTIs.

Rever et al (2026)⁴⁴ conducted a retrospective cohort study within a single healthcare system between January 1, 2020, and August 31, 2024, to evaluate the risk-benefit profile of initiating SGLT2 inhibitors in patients with and without a history of UTIs, including the incidence of post-SGLT2 inhibitor infections. A total of 250 patients were included, of whom 197 were UTI-naïve and 53 had a history of UTI.

• INVOKANA was prescribed to 1 patient. The incidence of UTI was 1/1 (100%) in the overall INVOKANA group and 1/1 (100%) in the UTI-naïve cohort, while 0/1 (0%) patients in the history-of-UTI cohort reported a UTI event (P=1).

Srimaya et al (2026)⁴⁵ investigated the prevalence rate of adverse drug reactions (ADRs) associated with SGLT2 inhibitor use (N=293). The ADRs assessed included acute kidney injury (AKI), acute pancreatitis, UTI, and euglycemic diabetic ketoacidosis, and evaluated factors associated with UTI occurrence. Overall, 59 ADRs were reported.

• UTI was reported in 9 (13.04%) patients receiving INVOKANA 100 mg, 14 (13.33%) patients receiving dapagliflozin 10 mg, 8 (11.59%) patients receiving luseogliflozin 5 mg, and 2 (4%) patients receiving Xigduo^®. The overall prevalence of UTI was 33/293 (11.6%; 95% CI, 8.42-15.78; P=0.334).
• Logistic regression analysis showed that female sex was associated with a 2.27-fold higher risk of UTI (95% CI, 1.07-4.95; P=0.031), AKI with a 3.27-fold higher risk (95% CI, 1.12-9.78; P=0.033), age ≥60 years with a 2.68-fold higher risk (95% CI, 1.07-7.01; P=0.033), and SGLT2 inhibitor use for <6 months with a 5.78-fold higher risk compared with use for ≥6 months (95% CI, 2.74-14.18; P=0.017).

Riaz et al (2024)⁴⁶ conducted a retrospective, active-comparator, new-user cohort study using the IBM^® MarketScan^® Commercial and Medicare Supplemental databases from January 1, 2012, to December 31, 2020. The study evaluated the comparative safety of SGLT2 inhibitors for the risks of UTI and genital infection among patients with heart failure with preserved ejection fraction (HFpEF). Before inverse probability of treatment weighting (IPTW), the study included 513 patients initiating INVOKANA, 415 patients initiating dapagliflozin, and 848 patients initiating empagliflozin. See Table: Risk of UTI or Genital Infection as Composite (Primary) or Separate Outcomes in Inverse Probability Treatment Weighting-Adjusted Analyses.

Mohammed et al (2018)⁴⁷ conducted a retrospective analysis utilizing the FDA FAERS data to compare UTI and genital fungal infection cases reported between March 2013 and November 2015 for 6 SGLT2 inhibitors and combination products, including INVOKANA and INVOKANA/metformin.

• UTI cases were captured with preferred terms: UTI, genitourinary tract infection, kidney infection, cystitis, and pyelonephritis.
• A total of 727 UTI cases were reported across the SGLT2 inhibitor class. INVOKANA as a single agent was associated with the greatest number of reports of UTI (n=503), however, there was a larger number of INVOKANA cases in total due to its time on the market. See Table: Number of UTI Cases Reported for INVOKANA and INVOKANA/Metformin.
  • Of the combination products, INVOKANA/metformin had the most UTI cases reported (n=8).

additional RELEVANT LITERATURE

Bellapu et al (2025)⁴⁸ conducted a 12-month prospective, interventional, comparative study in patients with T2DM (N=3456; INVOKANA, n=1854; dapagliflozin, n=1602) between January 2022 and January 2023 to evaluate the long-term effects of INVOKANA and dapagliflozin on urinary volume, renal status and metabolic changes.

• UTI was reported in 50/1504 (3%) patients receiving INVOKANA and 40/974 (4%) patients receiving dapagliflozin. Among patients receiving INVOKANA, 46 patients reported concurrent UTI and vaginal candidiasis, compared with 34 patients receiving dapagliflozin.

Shin et al (2025)⁴⁹ conducted an observational study designed to emulate 2 target trials comparing individual SGLT2 inhibitors for CV and safety outcomes in individuals with T2DM treated in clinical practice using data from 3 large US health insurance claims databases (Clinformatics, MarketScan, and Medicare). Data analyses were performed between August 2023 and July 2024.

• In the comparison of INVOKANA vs empagliflozin, severe UTI events occurred in 405 patients (IR, 3.7/1000 person-years) receiving INVOKANA and 410 patients (IR, 3.4/1000 person-years) receiving empagliflozin, with an HR of 1.13 (95% CI, 1.03-1.24).

Mechanism of development of utis

• People with diabetes are at higher risk for developing UTIs and their increased susceptibility is associated with increased duration and severity of diabetes. Clinical epidemiological data identifying mechanisms of increased UTI susceptibility in diabetes patients are lacking. The etiology of UTI in these patients may be multifactorial (eg, bacterial growth with glucose in urine) and is not fully established.^50,51
• Increase in urinary glucose excretion may increase bacterial growth in the perineum. Therefore, in the clinical development program, the effect of INVOKANA treatment on bacteriuria was examined in phase 2 studies.⁴² In addition, the incidence of AEs of UTI was evaluated in phase 2 and phase 3 studies and these results are summarized above.

PH EFFECTS

• In INVOKANA clinical studies, pH effects or acidification of urine and its impact on the incidence of UTI were not studied.

PREVENTATIVE THERAPY

• In INVOKANA clinical studies, pharmacologic prophylactic therapy was not administered for the prevention of UTIs.
• Please refer to the following website for information on non-pharmacological preventative methods:
  • National Center for Biotechnology Information, U.S. National Library of Medicine: www.ncbi.nlm.nih.gov/.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 20 July 2026.