SCI Model Systems Complicated Urinary Tract Infection (cUTI) Guidelines: International Consensus on cUTI Likelihood Based on Symptoms.

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Learn more: PMC Disclaimer | PMC Copyright Notice Top Spinal Cord Inj Rehabil . 2025 Aug 22;31(3):101–120. doi: 10.46292/sci25-00019 SCI Model Systems Complicated Urinary Tract Infection (cUTI) Guidelines: International Consensus on cUTI Likelihood Based on Symptoms Rochelle E Tractenberg 1, ✉ , Ana Valeria Aguirre Guemez 2, 3 , Marla Petriello 4 , Suzanne L Groah 2, 3 Author information Article notes Copyright and License information 1 Collaborative for Research on Outcomes and -Metrics and Departments of Neurology, Rehabilitation Medicine, and Biostatistics, Bioinformatics & Biomathematics, Georgetown University Medical Center, Washington, DC 2 MedStar National Rehabilitation Hospital, Washington, DC 3 MedStar Georgetown University Hospital, Washington, DC 4 Medrina, Chicago Illinois ✉ Corresponding author: Rochelle E. Tractenberg, Departments of Neurology, Biostatistics, Bioinformatics & Biomathematics, and Rehabilitation Medicine, Georgetown University, Washington, DC 20057; email: rochelle.tractenberg@gmail.com Issue date 2025 Summer. © 2025 American Spinal Injury Association PMC Copyright notice PMCID: PMC12376156  PMID: 40862211 Abstract Background: Complicated urinary tract infection (cUTI) is prevalent among people with spinal cord injury and disease (SCI/D). Diagnostic guidelines are neither consistent nor evidence based. Objectives: To establish consensus around symptoms-based diagnostic and decision-making criteria for cUTI for SCI/D. Methods: A representative sample of clinicians from PM&R, infectious disease, urology, and primary care within the United States (phase 1) and internationally (phase 2) participated in this study. Phase 1 involved focus groups and interviews to refine a decision-making paradigm for cUTI based on reliable and validated Urinary Symptom Questionnaires for Neurogenic Bladder (USQNBs: intermittent catheterization, indwelling catheterization, and voider versions). The phase 2 international Delphi survey on cUTI diagnostic criteria reflected phase 1 results. These criteria feature 6 “profiles”: combinations of symptom number and types with associated likelihood of cUTI for each USQNB (18 total decisions). Results: Analyses of the phase 1 transcripts ( n = 32) led to the Delphi design. Across the United States and internationally, 24 responses were obtained on the complete Delphi, with 48 responses on the USQNB for intermittent catheterization only. We achieved the a priori target 80% consensus on 13 of 18 decisions. The remaining 5 decisions reached 62.2% to 77.8% agreement. Changes were made based on respondent suggestions to clarify decisions and slightly modify risk descriptors. One hundred percent consensus among subject matter experts from 9 collaborating SCI model systems centers was achieved for the revisions. Conclusion: This is the first international and empirical initiative to establish cUTI symptoms-based guidelines for cUTI in SCI/D. These guidelines provide a coherent and evidence-based approach to decision making based on symptoms for clinicians and patients. Keywords: clinical guidelines, complicated UTI, diagnostic criteria, neurogenic lower urinary tract dysfunction (NLUTD), mixed methods, neurogenic bladder, SCI/D, Urinary Symptom Questionnaire for Neurogenic Bladder (USQNB), urinary tract infection (UTI) Introduction Urinary tract infection (UTI) is the most common outpatient infection worldwide. For people with spinal cord injury or disease (SCI/D) and neurogenic lower urinary tract dysfunction (NLUTD), UTIs are the most common infection, secondary condition, cause for emergency room visits, and infectious cause of hospitalization. 1 – 10 A UTI among people with NLUTD is considered “complicated,” and for that reason we refer to UTI in this population as complicated UTI (cUTI; although see Bonkat et al. 11 ). Currently there is no single accepted definition of cUTI for individuals with NLUTD, creating diagnostic subjectivity. The National Institute on Disability and Rehabilitation Research (NIDRR) established diagnostic criteria specific to individuals with SCI/D in 1992. Many groups have developed guidelines, often without specific consideration for SCI/D, for example, the Infectious Disease Society of America (IDSA) established a catheter-associated UTI (CAUTI) definition. Some symptoms on the IDSA guidelines are not relevant for individuals with high-level injuries. Further, diagnostic guidelines may include symptoms that are relevant for individuals without SCI/D but also include signs of inflammation (e.g., white blood cells in the urine/pyuria) and bacteria grown in urine culture, both of which are common in the absence of symptoms among people with SCI/D. 12 The IDSA (2009) guidelines explicitly advise against using white blood cells in the urine as a diagnostic criterion for this population, 13 but some recommendations, including those for the pediatric spina bifida population 14 and inpatient and outpatient SCI, 15 include bacterial count and/or inflammation as diagnostic indicators. A recent international survey of clinical practitioners from diverse specialties utilizes pyuria as a required criterion for a UTI diagnosis for persons not “capable of expressing or perceiving lower urinary tract symptoms,” 16 which includes individuals with SCI/D. Taken together, there is high variability across guidelines. 16 Table 1 outlines some of the discordance. 17 – 20 Table 1. Variability in definitions for diagnosis of cUTI in SCI/D Authoritative guideline Diagnostic approach suggestions NIDRR Consensus Statement (1992) 39 IDSA (2009) and EAU (2021) 13 · 40 SCI-High UTI Project (2019) 15 Pediatric UTI in SB (2013) 14 Inpatient Outpatient Definition / Criteria Symptoms Inflammation Bacteria Symptoms Bacteria Bladder symptoms + fever Bacteria Bladder symptoms + general symptoms Bacteria Symptoms Inflammation Bacteria Symptoms >1 symptom >1 symptom Number of symptoms unspecified Fever Fever (variable definitions) Fever ↑ Spasticity ↑ Spasticity ↑ Spasticity AD AD AD (not standard definition) Rigors Dysuria Dysuria Dysuria ↑ Incontinence ↑ Incontinence ↑ Incontinence Urgent urination Acute hematuria Unprovoked new gross hematuria Smelly and cloudy urine Change in urine odor and clarity Smellv and/or cloudv urine Vomiting Malaise Malaise Malaise Sense of unease Sense of unease Lethargy Lethargy Mental status change Pain over kidney Flank pain New back pain Bladder pain Suprapubic pain Pelvic pain Abdominal pain Orthostasis (outpatients) Pyuria (inflammation) Leukocytes in urine Pyuria (>10/HPF) New pyuria (amount undefined) Pyuria (>10/HPF) Bacteria 100 CFU/mL ifIC; 10,000 CFU/mL if condom catheter; any if indwelling catheter Bacterial load (>=1000 CFU/mL) Not directly addressed, recommend: >100 CFU/mL ifIC; >10,000 CFU/mL if void; Any detectable if suprapubic aspirate Bacterial load (>100,000 CFU/mL of a single organism) Open in a new tab Note: Grey shading identifies discordance. AD = autonomic dysreflexia; CFU = colony forming units; cUTI = complicated urinary tract infection; HPF = high powered field; IC = intermittent catheter. Adapted from Tractenberg RE, Groah SL, Frost JK, Yumoto F, Rounds AK, Ljungberg IH. Urinary symptoms among people with neurogenic lower urinary tract dysfunction (NLUTD) vary by bladder management. Top Spinal Cord Inj Rehabil. 2023;29(3):31-43. doi: 10.46292/sci22-00065 . Given the clinical discordance and the critical importance of prompt and accurate identification and treatment of cUTI in individuals with SCI/D, our team has focused on measurement of, and decision making around, relevant symptoms and symptom complexes without reference to laboratory results. To do so we developed 3 instruments to track urinary symptoms indicative of cUTI specific to people with SCI/D. These Urinary Symptoms Questionnaires for people with Neurogenic Bladder (USQNBs) were developed with a person-centered approach to patient-reported outcomes, 21 and they therefore depend on bladder management method (intermittent catheterization, 22 indwelling catheters, and voiders 23 , 24 ). The instruments include symptoms that are valid and reliable for the specific bladder management method 25 and that fall into 1 of 4 categories: clinical action needed (A), bladder-related (B1), urine quality (B2), and other/constitutional (C). The symptoms are bladder management method-specific, but the categories are common across all instruments. With this system of symptoms and categories, we created cUTI-likelihood profiles based on symptom numbers and types to help guide clinicians and patients in decision making about how to manage cUTI based on symptoms only. The objective of this project is to establish consensus on cUTI diagnosis based on these patterns of symptom counts and types, without appeal to laboratory values. To do this, we implemented a mixed-methods protocol, incorporating psychometric design features. 26 Methods This protocol, described previously, 26 proceeded in phases, beginning with semi-structured interviews with clinicians experienced with diagnosing and treating cUTI in individuals with NLUTD due to SCI/D (phase 1). The interviews focused on the symptom categories on all 3 USQNB instruments and on 6 cUTI-likelihood profiles. The interviews were conducted with clinicians from SCI, PM&R, urology, infectious disease, primary care, and emergency medicine specialties/certifications nationwide. These interviews represented a cognitive task analysis (CTA), establishment of “diagnostic cut score” determination using a body of work 27 approach to describe how clinicians parse the patient presentation, and standard setting (range finding/pinpointing) 27 for concretely describing the resulting decision-making features for each bladder management method. The results were leveraged in a Delphi survey we deployed internationally (phase 2). Phase 1 Interviews US-based clinicians were invited by participating centers in the Spinal Cord Injury Model Systems (SCIMS) network to participate in a 60- to 90-minute interview after providing informed consent. The elicitation of knowledge (CTA step 3) was the core purpose of our interviews, emphasizing engagement with decision making and whether and how urinary symptoms, inflammatory biomarkers, and bacterial load are utilized across specialties and locations. To facilitate the interview scripting, we utilized the technical features of standard setting, which is used in psychometric projects to describe performance at the “conceptual boundary between acceptable and unacceptable levels of achievement.” 28 Instead of “achievement,” we focused on boundaries of clinical decision making. We encouraged clinicians to consider the “conceptual boundary” between treatment decisions (e.g., “yes antibiotics,” “no antibiotics”) or other decisions (e.g., patient self-manage, refer patient for urologic evaluation, etc.). Table 2 presents the published symptom profiles 29 that were featured in the interviews. Table 2. Symptom profiles and decision-making based on USQNB-IC symptoms 29 Clinical action needed (A) Bladder (B1) Urine (B2) Other (C) Symptoms by type a Feeling feverish Increased tone/ spasticity (not bladder spasms) Bladder spasms frequency/ discomfort Abdominal/ suprapubic pain Dizziness Headache Autonomic dysreflexia Difficulty thinking, mental fogginess, forgetfulness, confusion Change in quality of pain when passing urine Change in quality of pain during catheterization Incontinence/ urine leakage Urinary urgency Increase in catheterization frequency Decreased catheter volume Blood in urine Worsesmelling urine Darker urine Cloudier/ sediment in urine Increase in fatigue, lethargy, or weakness Loss of appetite Malaise/ feeling unwell Altered sleep patterns Muscle aches Increase in positional pain Back pain Pain in the legs Nausea Change in bowel patterns Generalized abdominal discomfort or bloating Irritability Profile 1 ≥ 1 0 Any Patient: seek medical attention for evaluation Clinician: work up based on clinical evaluation 2 ≥ 1 ≥ 1 Any Patient: seek medical attention for assessment of cUTI Clinician: consider urinalysis and culture 3 0 ≥ 1 (but not 4 B1 with zero B2) Any Patient: self-manage bladder symptoms and monitor Clinician: advise patient to self-manage and monitor 4 0 ≥ 4 0 Any Patient: seek medical attention for assessment of bladder function Clinician: consider evaluation of bladder function 5 0 0 ≥ 1 Patient: monitor Clinician: advise patient to self-manage and monitor 6 0 0 0 Patient: monitor Clinician: advise patient to monitor Open in a new tab a Only the USQNB-Intermittent Catheter symptoms are listed here; the full instruments for each bladder management method were utilized in the interviews and surveys; items on all 3 USQNB instruments, and one exemplar survey are included in Appendix B . We conducted interviews to ensure that we had equal representation from the targeted medical specialties; all followed a (single) standardized script. These were audio recorded and imported into Dedoose 30 to be parsed and coded. Four coders were trained and experienced with interviewing, the software, and thematic analysis; they used a collaborative, iterative method of analysis to identify themes. 31 We explored clinician perspectives on the decisions until the data were saturated, that is, no new themes emerged. 32 Themes were member-checked for accuracy and validity with interviewees who were asked to review written summaries as thematic data analysis proceeded. Interviewers and 3 of the 4 coders were clinicians, and the thematic analyses were focused on actionable clinical decisions. The iterative thematic analysis included 2 independent coders conducting the analyses and checking each other's work. When themes conflicted, the research group discussed options together to achieve consensus. Either the discussions reached consensus, or new questions were integrated into the interview script. Phase 2 Delphi Survey We leveraged our published decision-making profiles together with the outputs of phase 1 to create a survey for deployment online. The profiles were arranged to display in a hierarchical order based on interviewees’ feedback. The objective was to use a Delphi method to achieve 80% consensus on each of 18 decisions about the 6 cUTI likelihood profiles across the 3 USQNB instruments ( Table 2 , but replicated for each instrument's symptoms). Iqbal and Pipon-Young note 33 that the first Delphi round may be used to establish the aspects those being surveyed will consider. They articulated that high response rates are essential to consensus building, and additional rounds may create fatigue in respondents. We addressed this first round with our 32 interviews. Our focus groups and interviews lasted 60 to 90 minutes, and respondents noted that participation was arduous. We front-loaded the development of the Delphi survey with these extensive interviews so the survey (consensus-building) might have the greatest chance of success. The Delphi survey was deployed using SurveyMonkey. It was designed to be completed online. Over a period of 10 months, clinicians were recruited to participate through the Spinal Cord Injury Model Systems (SCIMS) network, Neurogenic Bladder Research Group, Urinary Tract Infection Global Alliance, American Spinal Injury Association, International Spinal Cord Society, and by email invitation. We received feedback from respondents from the SCIMS network that they found the survey long and complex, consistent with interview feedback. However, most completed the survey in an average of 18 minutes, though some took longer due to interruptions. To address this, the survey's presentation, organization, and format were streamlined without changing the content. We shared the updated version with international cUTI listservs and via email to interested individuals outside of the US. Within the SCIMS network (only), we sent a new QR code for the USQNB-IC survey only, which garnered 17 additional responses. Other respondents (all international participants) were invited to complete the surveys on all 3 instruments. The survey was closed when invitations yielded zero responses within one week (roughly 10 months). One example survey (for the Voiders instrument) is included in Appendix B . The items on all 3 USQNB instruments, by symptom type and by bladder management, also appear in Appendix A . We asked respondents if they agreed with each of the 6 profiles and their makeup (symptoms and types), the risk of cUTI for a given profile, and the associated clinical decisions. Respondents were encouraged to comment on their agreement or disagreement with each decision. A second set of ratings were requested where we presented a single table for each bladder management method and asked respondents to rate the “risk of cUTI” given each profile (high, medium, low). We also asked about use of pyuria in diagnosing cUTI (yes/no, and if so, when), antibiotic prescription habits, and other contextual considerations (e.g., practice type, insurance, or any other circumstances of their practice or setting) for prescribing. A final question was to ask for “other comments.” Results Interviews Saturation was achieved with 32 interviews. Based on the interviews, the original decision-making profiles were organized into a hierarchical order, ensuring they were clearly mutually exclusive. After the interviews, we decided not to invite emergency department specialists for the Delphi survey, because their decisions were both very different from all other respondents (while being internally consistent) and because the considerations they used in their decision making about cUTI diagnosis and treatment were also fundamentally different from all others. Survey We received 45 responses from United States ( n = 36), Mexico ( n = 3), Argentina ( n = 2), and Canada, Spain, France, and Switzerland ( n = 1 each). Overall, 28 respondents completed the survey that included all 3 instruments, yielding 28 responses to the survey about the USQNB-V and USQNB-IDC. The vast majority of respondents were physicians ( n = 22 MDs and n = 2 DOs). Seventeen other respondents only completed the USQNB-IC. Of these IC-only completers, 16/17 were from the US (1 was from Switzerland), and 15/17 were either MD (14/17) or DO (1/17). Thus, we had a total of 45 eligible USQNB-IC respondents and 28 eligible USQNB-V and USQNB-IDC respondents. Profiles We obtained agreement on 13/18 questions (6 profiles x 3 instruments) about the likelihood of a symptomatic cUTI and clinical decision for each profile (see Table 3 ). Table 3. Agreement by USQNB instrument (bladder management method) across the six profiles cUTI likelihood profile USQNB bladder management method Voider (n = 28) Intermittent catheter (n = 45) Indwelling catheter (n = 28) Profile 1 (“higher likelihood of UTI”) 90.9% 91.1% 91.7% Profile 2 (“moderate likelihood of UTI”) 86.4% 77.8% 75% Profile 3 (“moderate to low likelihood of UTI”) 81.8% 86.7% 83.3% Profile 4 (“lower likelihood of UTI”) 63.6% 62.2% 62.5% Profile 5 (“low likelihood of UTI”) 87.5% 86.7% 87.5% Profile 6 (“lowest likelihood of UTI”) 100% 97.8% 100% Open in a new tab Note: Grey cells identify decisions that did not reach 80% agreement. The lowest agreement (62.2%-63.6%) was observed on profile 4 (lower likelihood of cUTI, higher likelihood of bladder function-specific complaint). For those using catheters (IDC, IC), profile 2 narrowly failed to reach 80% consensus. We examined all comments to confirm the consensus levels and to determine if there were themes underlying the failures to achieve consensus. Comments about disagreement were principally focused on the risk category labels. We made clarifying changes to the profiles and decisions as reflected in Table 4 , which were sent to 9 SCIMS research center teams (registered participants in this study; second round subject matter expert Delphi). One hundred percent consensus (9 center votes) was achieved in this second round. Table 4 and Figure 1 show the final decision-making algorithm. Figure 1 reflects a visualization of the consensus algorithm. Table 4. Consensus profiles and decisions with associated likelihoods of symptomatic cUTI Profile Symptom Type Decision Clinical action needed (A) Bladder (B1) Urine (B2) Other (C) Higher likelihood of symptomatic cUTI a At least one At least one (B1 or B2) Any Clinical decision: Work up based on clinical evaluation, including urinalysis/urine culture Patient decision: Seek medical attention for probable symptomatic cUTI. Moderate likelihood of symptomatic cUTI At least one Zero Zero Any Clinical decision: Work up based on clinical evaluation, including urinalysis and urine culture Patient decision: Seek medical evaluation for possible symptomatic cUTI. OR Zero At least one At least one Any Changes to profile: Change: “medium likelihood of cUTI” to “moderate likelihood of cUTI”; add “symptomatic” Moderate to low likelihood of symptomatic cUTI Zero At least 4 Zero Any Clinical decision: Consider evaluation with urinalysis and other genitourinary assessment as indicated, including bladder pathophysiology Patient decision: Consider seeking medical attention specifically focused on bladder function Changes to profile: Change: “lower likelihood of cUTI” to “moderate to low likelihood of symptomatic cUTI”; add “symptomatic” Change decision: “consider evaluation of bladder function” to “consider evaluation with urinalysis and other genitourinary assessment as indicated, including bladder pathophysiology” Lower likelihood of symptomatic cUTI a Zero Zero At least one At least one Clinical decision: Advise patient to self-manage and monitor Patient decision: Self-manage and selfmonitor OR Zero 1-3 Zero Zero Low likelihood of symptomatic cUTI a Zero Zero At least one Clinical decision: Advise patient to self-manage and monitor Patient decision: Self-manage and selfmonitor Lowest likelihood of symptomatic cUTI a Zero Zero Zero Clinical decision: Advise patient to self-monitor Patient decision: Continue to selfmonitor Open in a new tab Note: cUTI = complicated urinary tract infection. a No changes were made to this profile because consensus (80% agreement) was achieved, but we modified the profile to characterize cUTI as “symptomatic.” Figure 1. Open in a new tab Consensus algorithm visualization. Risk ratings Respondents next chose from a drop-down menu a level of risk (high, medium, low, none) of cUTI to attribute to each profile, separately for each USQNB. We included these items as a convergent validity check on the profiles section of the survey. The greatest agreement was observed for profile 1, the highest cUTI likelihood profiles: 93.1% of respondents rated the risk of cUTI given this symptom pattern “high” for those managing their bladder with IDC, 95.5% rated risk of cUTI for this profile “high” for voiders, and 80.5% rated risk of cUTI to be “high” for those using IC. Agreement on these risk ratings was marginally higher in this section of the survey for IDC and V, but lower for IC, compared to the profiles section. For example, respondents rated the risk of cUTI for patients using intermittent catheters, with no symptoms at all (profile 6, lowest likelihood of cUTI), to be “low” 6/41, “medium” (2/41), and “high” (1/41), representing 78% agreement on “none,” whereas 97.8% of respondents agreed with the profile “lowest likelihood of UTI” in the profiles part of the IC survey. In addition to divergent levels of agreement in the risk ratings with agreement in the profiles section of the survey, the nonresponse rate was higher for this and subsequent sections of the survey. The divergence in agreement on risk assessment from the earlier responses on the profiles made these risk ratings difficult to reconcile with the profile agreements and comments from the same respondent. In many cases, comments about likelihood of cUTI assigned to profiles in the first part of the survey did not match the risk ratings towards the end of the survey. Given the variability within this section, and the disagreement by respondents with their own earlier ratings in the profiles section and their own comments, we were unable to confidently interpret these risk assessments. Pyuria, bacterial load, and treatment of asymptomatic bacteriuria In addition to profile-based consensus and risk ratings, we asked about practice relating to the use of pyuria, bacterial load, and treatment practice relating to asymptomatic bacteriuria (ASB). Table 5 shows these results by bladder management (USQNB instrument). Table 5. International responses about using pyuria, bacterial load, and treatment of ASB in cUTI diagnosis by bladder management method of the patient Intermittent catheterization Indwelling catheterization Voider Use pyuria? 28/45 (62.2%) yes 15/24 a (62.5%) yes 17/22 a (77.3%) yes Use bacterial load? 29/44 (63.6%) yes (1 NR) 12/23 (52.2%) yes (1 NR) 13/22 (59.1%) yes Treat asymptomatic bacteriuria in specific circumstances? 23/41 (56.1%) yes (4 NR) (circumstances: treat with irrigation, pregnancy, stone growing pathogen, prior to procedure, diabetes/ compromised) 16/23 (69.6%) yes (circumstances: pregnancy, stone growing pathogen, prior to procedure, diabetes/ compromised) 10/22 (45.5%) yes (circumstances: pregnancy, stone growing pathogen, prior to procedure, diabetes/ compromised) Open in a new tab Note: ASB = asymptomatic bacteriuria; cUTI = complicated urinary tract infection; NR= no response (to this question, but responses to others in this section). a Not all who completed the profile and risk sections of the survey completed this part of the survey so these numbers do not match the totals in Table 3 . The results we obtained about pyuria and bacterial load were variable, which is consistent with the wide range of guidelines shown in Table 1 . Clinicians who completed the surveys for the IDC and V instruments seem to utilize pyuria and bacterial load somewhat differently depending on the patient's bladder management method. Circumstances for treating asymptomatic bacteriuria were very similar across bladder management methods. Discussion This study represents the first empirical initiative to engage an international pool of clinical decision makers of various specialties actively working “in the field” in the establishment of symptom-based cUTI guidelines for individuals with NLUTD due to SCI/D. This method combined a valid and reliable set of patient-centered, patient-reported instruments with clinical experience and current initiatives towards antimicrobial stewardship with a rigorous qualitative paradigm, moving beyond traditional consensus methods to a structured and evidence-informed approach. Unlike recent multidisciplinary UTI criteria (Bilsen et al. 34 ), these guidelines rely on valid and reliable symptoms specific to NLUTD due to SCI/D and to bladder management method and not on pyuria, systemic criteria, or culture results. Throughout this process, we observed in interviews and focus groups that defining a cUTI in the SCI/D population poses significant challenges to clinicians across specialties. This may be one reason for the discordance amongst UTI guidelines in this population. This difficulty likely contributed to lower-than-expected survey response rates. Another reason for the lower-than-expected survey response rates might be a stark difference between the schema or mental model most clinicians develop around cUTI diagnosis and treatment and the schema that our symptoms-focused and type-and-number profiles approach represents. The apparent misalignment between the schema represented in the profiles and the survey and the mental models of study participants (interviewees and others who communicated via email) represents a very clear signal about the need for careful consideration of a cognitive strategy in developing training materials to help clinicians learn to utilize the USQNB instruments in practice. We have developed training materials for both patients and for clinicians that will be useful for studying uptake (by clinicians) and impact (on patient outcomes). We also included questions about the use of inflammatory markers and bacterial growth because these are components of some conventional diagnostic frameworks for UTI diagnosis and treatment. 34 Although our study did not aim to estimate the true prevalence of their use in cUTI diagnosis, and the sample size is limited, our findings reveal notable variability in the use, or perceived utility, of inflammatory markers and bacterial growth in cUTI diagnosis for individuals with NLUTD. This is particularly significant given that existing guidelines (IDSA 2009) advise against using white blood cell count (WBC) as a determinant for UTI, while Bilsen et al. 34 include WBC (cell count ≥12×10 9 per L) as one way to meet “systemic criteria” for UTI. However, our results suggest that some clinicians continue to rely on WBC as part of their diagnostic process, which has also been reported for pediatric 35 as well as nonpediatric 36 populations with SCI/D. Our findings that a significant proportion of clinicians treat asymptomatic bacteriuria in spite of guidelines not to do so are consistent with other reports. 36 However, it is important to note that frequent reasons for use of this practice include doing so in pregnant women and in the context of a urologic procedure or stone, which may be clinically appropriate. Biomarkers in blood and urine for inflammation indicative of infection are currently under study. 37 , 38 Recent guidelines for UTI in persons without SCI/D (Bilsen et al. 34 ) include pyuria (≥10 leukocytes per μL or ≥5 leukocytes per hpf) as a requirement for a UTI diagnosis in individuals who are not “capable of expressing or perceiving lower urinary tract symptoms” 34 (p.e517) (although the scoring algorithm depends on the number of specific symptoms that are expressed). There is a critical need to address the utility and limitations of the use of inflammatory biomarkers for cUTI in SCI/D and to support training initiatives to improve evidence-based antibiotics use for cUTI in this population. Our approach features symptoms alone, without laboratory values, to support decisions based on the likelihood of cUTI by both patients and clinicians. This approach does not preclude the use of UA/UC and other aspects of clinical evaluation, but understanding the likelihood of UTI based solely on symptoms can help determine the extent to which laboratory values may support clinical decision making. Limitations of this study include the small sample size and extremely low international response rates. Compared to the size of teams that have led to other guidelines prior to 2024, our survey captured a very wide range of specialties, countries, and practitioners. We recognize that only highly motivated, self-selected respondents participated in our survey, but this set of characteristics is also true for specialists and subject matter experts who are invited to contribute to other guidelines development efforts. An important aspect of the input we received about the difficulties respondents encountered, both in our interviews and in the survey comments, is that the training to use the USQNB and these profiles must include a cognitive strategy that can help overcome these challenges. Rather than try to simplify the algorithm, training clinicians and patients is our team's next step. This training focuses on practice with the USQNB instruments and developing familiarity with the symptoms relevant for each bladder management method. Conclusion This study represents the first international initiative to engage clinical decision makers in a formal and structured qualitative research approach to develop symptom-based guidelines for cUTI among individuals living with SCI/D. We have developed the USQNB instruments, symptom categories, and profiles with their attendant decisions for clinicians and patients as guidelines for diagnosing and decision making around cUTI for individuals with NLUTD due to SCI/D. These guidelines are unique in providing symptom-based cUTI likelihood profiles to assist clinicians in decision making for themselves and also for patients in their self-management. Recognizing the limited diagnostic value of bladder inflammation and urine biomarkers of inflammation and bacterial load in this population, these symptom-based guidelines are offered as a coherent method to allow patients and clinicians to recognize the baseline state and to be sensitive to changes that might indicate a cUTI. Our next steps are to create and implement training programs for clinicians and patients on how to use the USQNBs and the guidelines for decision making in clinical practice. Our team is also seeking to make the USQNB instruments and decision-making algorithm and guidelines available through common electronic medical record programs. APPENDIX A USQNB Symptoms by Type, by Bladder Management Method Actionable Signs/Symptoms (A) V IC IDC □ □ □ Bladder spasm frequency/discomfort □ □ □ Feeling feverish □ □ □ Increased tone or spasticity (not bladder spasms) □ - - Difficulty ambulating □ □ □ Difficulty thinking, mental fogginess, forgetfulness, confusion - □ - Dizziness - □ - Headache - - □ Flushing of the chest, neck or face - - □ Bladder discomfort □ - □ Sweating □ □ □ Autonomic dysreflexia (AD; SCI only) - □ □ Abdominal/ suprapubic pain □ - - MS flare-up (multiple sclerosis only) Open in a new tab Bladder Signs/Symptoms (B1) V IC IDC □ □ □ Blood in urine □ □ □ Urinary urgency □ □ □ Incontinence/urine leakage □ - - Increase frequency of urination □ - - Sensation of urgency, empty bladder □ - - Inability to fully empty bladder □ - - Weak urine stream - □ - Change in quality of pain when passing urine - □ - Change in quality of pain during catheterization - □ - Increase in catheterization frequency - - □ Blood clots in urine □ □ - Reduced urine volume (V)/ decreased catheter volume (IC) Open in a new tab Urine Quality Signs/Symptoms (B2) V IC IDC □ □ □ Worse-smelling urine □ □ □ Darker urine □ □ □ Cloudier/sediment in urine Open in a new tab Other (C) V IC IDC □ □ □ Increase in fatigue, lethargy, or weakness □ - Loss of appetite □ □ - Malaise/feeling unwell - □ - Altered sleep patterns - □ - Muscle aches - □ - Increase in positional pain - □ □ Back pain - □ - Pain in the legs □ □ - Nausea - □ - Change in bowel patterns - □ □ Generalized abdominal discomfort or bloating - □ □ Irritability - - □ Discharge, redness, or sensitivity around catheter site - - □ Increase or decrease from your usual blood pressure - - □ Diarrhea - - □ Numbness, tingling in your extremities - - □ Sense of burning in the extremities or throughout the body - - □ Pain below the level of injury □ - - Chills □ - - Vomiting Open in a new tab Online profile calculator: Enter symptoms experienced at greater than usual levels to obtain profile. https://lxd.sitelms.org/cUTI/story.html APPENDIX B SURVEY Survey questions were identical but symptoms specific to the instrument, by type, were presented to respondents ahead of each set of questions about that specific set of symptoms. cUTI Delphi SURVEY Contents Note: Participants either only answered questions relating to the USQNB-IC (intermittent catheter), for which they were shown those items, or they were shown the items on each instrument and asked questions about each separately. The set of symptoms, by category, were presented together with each of the profiles so respondents could refer directly to the instrument while answering. Demographics Years in practice (postresidency/fellowship) Which of the following best describes your current occupation? Select the area(s) of specialization that applies to you. In what country do you practice in? (Please specify the state or province.) Please specify the city or cities. On average how many SCI patients with neurogenic lower urinary tract dysfunction (NLUTD) do you see per month in the inpatient setting? On average how many SCI patients with neurogenic lower urinary tract dysfunction (NLUTD) do you see per month in the outpatient setting? What is the age range of your patients? (Select all that apply.) Do you diagnose and treat UTI or cUTI in individuals with neurogenic bladder? Three Urinary Symptom Questionnaires for persons with Neurogenic Bladder (USQNB) were published for people using different bladder management methods (intermittent catheter [USQNB-IC], indwelling catheter [USQNB-IDC], and voiding [USQNB-V]). All of the items on each instrument have been designated as falling into 1 of 4 item types: “action needed” (A type), “bladder-related” (B1 type), “urine quality” (B2 type), and “constitutional or other” (C type). On the following set of questions, we want you to consider your experience with individuals with NB who use intermittent catheter (IC), indwelling catheter (IDC), or are voiders (V) to manage their bladder. Each profile is reflected in a table. Indicate whether you agree or disagree with the profile and decision for each bladder management selected for this set of questions. If you disagree, choose the option that best applies. Please comment on your choice for each question. Profile 1. Higher likelihood of UTI Open in a new tab Decision: Consider urinalysis and culture 10. Do you agree with symptoms and decision for profile 1? Agree with symptoms and decision Disagree - add/remove symptom Disagree - decision not appropriate for profile Please elaborate on your choice: Note: The same questions (10-24) were asked for each bladder management method-specific USQNB. Profile 2. Medium likelihood of UTI Open in a new tab Decision: Based on clinical evaluation consider blood work, urinalysis, urine culture, etc. 11. Do you agree with symptoms and decision for profile 2? Note: There are 2 ways to meet profile 2: either with at least one A and no B1 or B2 symptoms or with no A symptoms and at least one B1 and B2 symptom. Agree with symptoms and decision Disagree - add/remove symptom Disagree - decision not appropriate for profile Please elaborate on your choice: Profile 3. Lower likelihood of UTI Open in a new tab Decision: Advise patient to self-manage urinary symptoms, notify clinician of changes 12. Do you agree with symptoms and decision for profile 3? Agree with symptoms and decision Disagree - add/remove symptom Disagree - decision not appropriate for profile Please elaborate on your choice: Profile 4. Lower likelihood of UTI Open in a new tab Decision: Consider evaluation/management of bladder function 13. Do you agree with symptoms and decision for profile 4? Agree with symptoms and decision Disagree - add/remove symptom Disagree - decision not appropriate for profile Please elaborate on your choice: Profile 5. Lower likelihood of UTI Open in a new tab Decision: Advise patient to self-manage and monitor, notify clinician of changes 14. Do you agree with symptoms and decision for profile 5? Agree with symptoms and decision Disagree - add/remove symptom Disagree - decision not appropriate for profile Please elaborate on your choice: Profile 6. Lowest likelihood of UTI Open in a new tab Decision: Advise patient to notify clinician of changes 15. Do you agree with symptoms and decision for profile 6? Agree with symptoms and decision Disagree - add/remove symptom Disagree - decision not appropriate for profile Please elaborate on your choice: 16. Are there other symptoms, not on the USQNB, that you consider when you diagnose cUTI? (List) The next set of questions are about your general approach relating to cUTI for individuals the specific bladder management. 17. Do you use pyuria in your diagnosis of cUTI? No Yes 0-5 /HPF Yes 6-10 /HPF Yes 10-50 /HPF Yes more than 50/HPF If there are other values you use [for the bladder management method], please specify the cutoff value/range and units you use for each indicator (WBC, HPF, other) when you use pyuria in your diagnosis of cUTI. 18. Which inflammatory markers do you consider in diagnosis of cUTI? None (required comment below) If you use them, please go on to the next question. Comment: 19. List the inflammatory markers you consider in diagnosis of cUTI. Note: If response to item 18 was “none,” respondent was skipped to item 20. 20. Please describe how you define “change from usual” for each inflammatory marker in your diagnosis of cUTI for individuals using [the specific bladder management] in the comment box below. I do not consider “change from usual” for inflammatory markers. I consider “change from usual.”. Describe your definition(s): 21. Please describe bacterial load (growth on urine culture) thresholds you use in diagnosing cUTI in persons [using the specific bladder management]. I do not use bacterial load in my diagnosis of cUTI in persons [using the specific bladder management]. I use bacterial load thresholds in diagnosing cUTI in persons [using the specific bladder management]. Please elaborate on bacterial load thresholds (specify values) you use in diagnosing cUTI in persons [using the specific bladder management]. 22. Please elaborate on how you define “change from usual” in bacterial load (growth on urine culture), diagnosing cUTI in persons [using the specific bladder management]. I do not use “change from usual” in bacterial load diagnosing cUTI in persons in persons [using the specific bladder management]. I use “change from usual.” (Please describe your definition(s) in the comment box below.) 23. Describe when you would treat asymptomatic bacteriuria in individuals [using the specific bladder management]. I do not treat asymptomatic bacteriuria in individuals using in persons [using the specific bladder management]. I treat asymptomatic bacteriuria in specific scenarios. (Please elaborate on when you would treat asymptomatic bacteriuria). The following questions are about your suspicion of cUTI with this bladder management. For each profile, rate your level of suspicion of a cUTI when an individual who uses this bladder management presents with the specific symptoms present/absent. Note: The USQNB for the survey's bladder management method appeared with all symptoms separated by category together with the risk rating table. The table, however, that appears in item 24 is the same for every survey although the symptoms vary by bladder management method. 24. Choose the level of suspicion of a UTI that you have given each profile in the table. None Low Medium High Profile 1. Higher likelihood of UTI (>1A; >1B1/B2; Any C) Profile 2. Medium likelihood of UTI (>1A; 0 B1/B2; Any C) or (0 A; >1 B1/B2; Any C) Profile 3. Lower likelihood of UTI (0 A; 0 B1 and >1B2; Any C) Profile 4. Lower likelihood of UTI (0 A; >4B1 and 0B2; Any C) Profile 5. Lower likelihood of UTI (0 A; 0 B1 and 0B2; >1C) Profile 6. Lowest likelihood of UTI (0A; 0 B1; 0B2; 0C) Open in a new tab 25. Are there any characteristics of your workplace (e.g., insurance provisions, health care system, resource allocation) that play a role in your decision making about cUTI in persons with a neurogenic bladder NB or NLUTD? Do these characteristics depend at all on the patient's bladder management method? 26. Are there any factors that we haven't asked about that play a role in your decision making about cUTI in persons with a NB or NLUTD? If yes, please list them in the comment field below and indicate if they depend on the patient's bladder management method. No Please list any factors in cUTI decision making this survey doesn't cover and indicate if they depend on bladder management method. Footnotes Conflicts of Interest The authors declare no conflicts of interest. 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