rinary tract infections in postmenopausal women revisited

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

1. Postmenopausal woman, defined as having had the last menstrual period at
least 12 months ago.
2. RUTI group: having had a UTI at least three times in the last 12 months OR
Control group: not having had a UTI in the last 12 months and never having had
a RUTI diagnosis in the past.
3. Willing and able to complete the expected tasks described in the study
protocol, including answering questions in Dutch or English; allowing home
visits by study staff as needed; allowing study staff to obtain medical
information relevant to the study objectives from the GP; and allowing study
staff to share pseudonymised study samples and data (i.e. identified by
participant identification code only) within the UTIr project consortium.

Exclusion Criteria

1. Having an anatomical abnormality or chronic disease of the urinary tract or
kidneys, or having received a kidney transplant.
2. Having a urinary catheter in place.
3. Using exogenous progestogens and/or oestrogens and/or anti-oestrogen
treatment. Women become eligible again if their last hormonal use is at least 6
months ago.
4. Having a chronic condition and/or using medications that significantly
influence the immune system and/or bacterial growth. Women become eligible
again if their last medication use is at least 6 months ago. Women who use
supplements to prevent or treat UTIs (such as cranberries or d-mannose) are
eligible. Women cannot use vaginal probiotics containing lactobacilli during
the study; they can be enrolled after at least one month has passed since their
last use.
5. Having to undergo a substantial planned medical intervention, such as
surgery, during the follow-up period.
6. Planning a prolonged absence from the Netherlands during the follow-up
period.
7. Women in both groups who have a genital infection at the time of recruitment
must first be treated for that infection and can be included when at least 2
weeks have passed after the end of treatment and they are symptom-free.
8. Women in the RUTI group who have a UTI at the time of recruitment can be
included but baseline procedures will be slightly adjusted.
9. Women in the RUTI group who use antibiotics chronically to manage their
RUTI, or vaginal oestrogen-containing creams for RUTI prophylaxis, will be
excluded in the first instance but may become eligible later on during
recruitment if required to reach recruitment targets.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Urobiome composition by 16S rRNA sequencing/qPCR: alpha and beta diversities,<br /><br>relative and absolute abundances of key taxa (typically up to genus level), and<br /><br>urobiome clusters (urotypes). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Urobiome composition by metagenomic sequencing: same as above but at species<br /><br>and strains level; plus relative abundances of bacterial (other than bacterial<br /><br>16S genes) and non-bacterial genes in urine.<br /><br>• Vaginal, vulvoperineal, and intestinal microbiome composition - same<br /><br>endpoints as described above for urobiome composition.<br /><br>• Urine metabolome composition.<br /><br>• Results of the co-culture and urothelium organoid experiments with bacterial<br /><br>isolates obtained from samples collected in the cohort study.</p><br>