The Urinary Microbiome in Women Using Single-Use Versus Reusable Catheters for Intermittent Catheterization: An Exploratory Substudy of the COMPaRE Trial

Study information

Needs review

study design

randomized controlled trial

Citation

PMID PubMed identifier for scientific articles.

40708214

DOI Digital object identifier for electronic documents.

https://doi.org/10.1002/nau.70119

URI Uniform resource identifier for web resources.

Authors

van Veen FEE, Serkani ZE, Berendsen S, Kraaij R, Bode L, Hays JP, Scheepe JR, Blok BFM

Journal

Neurourology and urodynamics

Year

2025

Keywords:

microbiota, sustainable development, urinary bladder, urinary catheters, urinary tract infections

AIMS: To characterize the urinary microbiome in women performing clean intermittent self-catheterization (CISC) and explore microbial changes associated with transitioning from single-use to reusable catheters. METHODS: This microbiome study of the COMPaRE trial included female CISC patients with urinary retention randomized to either single-use or reusable catheters. Self-catheterized urine samples were collected at baseline and Week 6 for standard culture and 16S rRNA microbiome analysis. RESULTS: A total of 28 patients (12 reusable, 16 single-use) were included, with a median age of 48 years (IQR 32-60); 67.9% had neurogenic lower urinary tract dysfunction. Escherichia-Shigella (36.3%) and Lactobacillus (22.8%) were the most prevalent genera. PERMANOVA identified significant effects of age (p = 0.003), menopausal status (p < 0.001), and catheterization cause (p = 0.003) on microbiome composition. Transitioning to reusable catheters was associated with significant reductions in Escherichia-Shigella (p < 0.001) and Aerococcus (p < 0.001), and increases in Veillonella (p < 0.001) and Finegoldia (p < 0.001). No significant changes were observed in urine culture results (p = 0.250), alpha diversity as measured by the Shannon index (p = 0.862), or beta diversity as assessed by Bray-Curtis distance (p = 0.096). CONCLUSIONS: Escherichia-Shigella and Lactobacillus were the most abundant genera in the urinary microbiome of women performing CISC. Age, menopausal status, and catheterization cause significantly influenced microbiome composition. Although specific microbial shifts were observed following transition to reusable catheters, no significant changes in overall microbial diversity were detected. Larger, well-powered studies are needed to validate these results and assess their potential clinical implications. TRIAL REGISTRATION: Clinical Trial RegistrationNL-OMON54700/NL8296.

Experiment 1

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Curated date: 2025/08/12

Curator: Martha KJ

Revision editor(s): Martha KJ

Subjects

Location of subjects: Netherlands

Host species Species from which microbiome was sampled. Contact us to have more species added.: Homo sapiens

Body site Anatomical site where microbial samples were extracted from according to the Uber Anatomy Ontology: Lower urinary tract Lower urinary tract,lower urinary tract

Condition The experimental condition / phenotype studied according to the Experimental Factor Ontology: Urinary retention Increased post-void residual urine volume,Urinary retention,urinary retention

Group 0 name Corresponds to the control (unexposed) group for case-control studies: Control arm / Single-use group

Group 1 name Corresponds to the case (exposed) group for case-control studies: Intervention arm / Reusable group

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group: Patients using reusable catheters (Cliny or PureCath brands) cleaned and stored in 1:80 dilution of 2% sodium hypochlorite, with each catheter used for 2 weeks

Group 0 sample size Number of subjects in the control (unexposed) group: 16

Group 1 sample size Number of subjects in the case (exposed) group: 12

Antibiotics exclusion Number of days without antibiotics usage (if applicable) and other antibiotics-related criteria used to exclude participants (if any): Antibiotic treatment in the past 3 months (except for prophylaxis) Additional note: "Patients with missing samples or those receiving antibiotics during follow‐up were excluded" from certain analyses

Lab analysis

Sequencing type: 16S

16S variable region One or more hypervariable region(s) of the bacterial 16S gene: V1-V3

Sequencing platform Manufacturer and experimental platform used for quantifying microbial abundance: Illumina

Statistical Analysis

Data transformation Data transformation applied to microbial abundance measurements prior to differential abundance testing (if any).: relative abundances

Statistical test: DESeq2

Significance threshold p-value or FDR threshold used for differential abundance testing (if any): 0.01

MHT correction Have statistical tests be corrected for multiple hypothesis testing (MHT)?: Yes

Matched on Factors on which subjects have been matched on in a case-control study: Matched on: "Randomized trial design" is not in the list (abnormal glucose tolerance, acetaldehyde, acute graft vs. host disease, acute lymphoblastic leukemia, acute myeloid leukemia, adenoma, age, AIDS, alcohol consumption measurement, alcohol drinking, ...) of allowed values.Randomized trial design, Matched on: "Baseline characteristics balanced between groups" is not in the list (abnormal glucose tolerance, acetaldehyde, acute graft vs. host disease, acute lymphoblastic leukemia, acute myeloid leukemia, adenoma, age, AIDS, alcohol consumption measurement, alcohol drinking, ...) of allowed values.Baseline characteristics balanced between groups, Matched on: "Paired samples (same patients at Week 0 and Week 6)" is not in the list (abnormal glucose tolerance, acetaldehyde, acute graft vs. host disease, acute lymphoblastic leukemia, acute myeloid leukemia, adenoma, age, AIDS, alcohol consumption measurement, alcohol drinking, ...) of allowed values.Paired samples (same patients at Week 0 and Week 6)

Confounders controlled for Confounding factors that have been accounted for by stratification or model adjustment: age, Confounders controlled for: "BMI (Body Mass Index)" is not in the list (abnormal glucose tolerance, acetaldehyde, acute graft vs. host disease, acute lymphoblastic leukemia, acute myeloid leukemia, adenoma, age, AIDS, alcohol consumption measurement, alcohol drinking, ...) of allowed values.BMI (Body Mass Index), Confounders controlled for: "Menopausal status" is not in the list (abnormal glucose tolerance, acetaldehyde, acute graft vs. host disease, acute lymphoblastic leukemia, acute myeloid leukemia, adenoma, age, AIDS, alcohol consumption measurement, alcohol drinking, ...) of allowed values.Menopausal status, Confounders controlled for: "CIC (Clean Intermittent Catheterization) frequency" is not in the list (abnormal glucose tolerance, acetaldehyde, acute graft vs. host disease, acute lymphoblastic leukemia, acute myeloid leukemia, adenoma, age, AIDS, alcohol consumption measurement, alcohol drinking, ...) of allowed values.CIC (Clean Intermittent Catheterization) frequency, Confounders controlled for: "Catheterization cause (neurogenic vs non-neurogenic)" is not in the list (abnormal glucose tolerance, acetaldehyde, acute graft vs. host disease, acute lymphoblastic leukemia, acute myeloid leukemia, adenoma, age, AIDS, alcohol consumption measurement, alcohol drinking, ...) of allowed values.Catheterization cause (neurogenic vs non-neurogenic)

Alpha Diversity

Pielou Quantifies how equal the community is numerically: unchanged

Shannon Estimator of species richness and species evenness: more weight on species richness: unchanged

Chao1 Abundance-based estimator of species richness: unchanged

Simpson Estimator of species richness and species evenness: more weight on species evenness: unchanged

Inverse Simpson Modification of Simpsons index D as 1/D to obtain high values in datasets of high diversity and vice versa: unchanged

Richness Number of species: unchanged

Faith Phylogenetic diversity, takes into account phylogenetic distance of all taxa identified in a sample: unchanged

Signature 1

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Source: Figure 5

Description: Opportunistic bacterial taxa significantly increased in women using reusable versus single-use catheters for clean intermittent self-catheterization. Veillonella, while found in healthy urinary microbiomes, has been associated with bladder cancer and stress urinary incontinence in other studies. Finegoldia magna, commonly detected in asymptomatic women, has been linked to worsening urinary symptoms before pelvic surgery. Study involved 28 female patients (67.9% neurogenic dysfunction) with 6-week follow-up, analyzed by 16S rRNA sequencing and DESeq2 differential abundance analysis (p<0.01).

Abundance in Group 1: increased abundance in Intervention arm / Reusable group

NCBI	Quality Control	Links
Veillonella (p < 0.001)Veillonella (p < 0.001)
Finegoldia (p < 0.001)Finegoldia (p < 0.001)

Revision editor(s): Martha KJ

Signature 2

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Source: Figure 5

Description: Potential uropathogens significantly reduced in women transitioning to reusable catheters for clean intermittent self-catheterization. Escherichia-Shigella, the most abundant genus overall (36.3% prevalence), and Aerococcus both showed marked decreases, potentially indicating reduced urinary tract infection risk. However, the paper notes that E. coli presence may not be a reliable UTI predictor, as infections are influenced more by overall microbiome composition than specific pathogens. No significant difference in actual UTI rates was observed between groups during the study period. Study involved 28 female patients with neurogenic/non-neurogenic urinary retention, 6-week randomized controlled design.

Abundance in Group 1: decreased abundance in Intervention arm / Reusable group

NCBI	Quality Control	Links
Aerococcus (p < 0.001)Aerococcus (p < 0.001)
Escherichia-Shigella (p < 0.001)Escherichia-Shigella (p < 0.001)

Revision editor(s): Martha KJ