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Integrated Urinary Microbiomes and Metabolome Signatures in Breast Cancer Survivors on Aromatase Inhibitors: Novel Insights into OAB Symptoms

Integrated Urinary Microbiomes and Metabolome Signatures in Breast Cancer Survivors on Aromatase Inhibitors Novel Insights into OAB Symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20260217003
Enrollment
60
Registered
2026-02-17
Start date
2026-02-09
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive bladder symptoms Genitourinary syndrome of menopause Urinary microbiome dysbiosis Urinary metabolomic alterations in breast cancer survivors on aromatase inhibitors Overactive Bladder Urinary Microbiome Metabolomics Breast Cancer Survivors Aromatase Inhibitors Genitourinary Syndrome of Menopause Lower Urinary Tract Symptoms Urine Metabolome Microbial Dysbiosis Precision Medicine

Interventions

Postmenopausal breast cancer survivors aged 50 to 65 years receiving letrozole or anastrozole for more than 6 months who meet symptom based overactive bladder criteria using Overactive Bladder Symptom
Basic Science,Basic Science
OAB,Non OAB

Sponsors

International Urogynecological Association
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Female sex 2. Age 50 to 65 years 3. Postmenopausal status defined as amenorrhea for at least 12 months without prior hysterectomy 4. History of breast cancer 5. Receiving letrozole or anastrozole for more than 6 months 6. Able and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Abnormal vaginal bleeding 2. History of menopausal hormone therapy 3. Antibiotic use within the past 30 days 4. Urinary catheterization or bladder or urethral procedures within the past 30 days 5. Current urinary tract infection or infection within the past 4 weeks 6. Treatment or medication for urinary symptoms within the past 30 days 7. Pelvic organ prolapse stage 2 or higher 8. Neurological disorders affecting bladder function 9. Diabetic cystopathy or bladder outlet obstruction 10. Use of medications affecting bladder activity 11. History of bladder or pelvic malignancy or pelvic radiation 12. Prior pelvic surgery affecting bladder function 13. Severe cognitive impairment or psychiatric illness 14. Uncontrolled systemic disease 15. Incomplete data or refusal to participate

Design outcomes

Primary

MeasureTime frame
Urinary microbiome composition Single visit baseline at enrollment 16S rRNA gene sequencing of midstream urine with comparison of relative abundance and diversity between OAB and non OAB groups

Secondary

MeasureTime frame
Urinary metabolome profile Single visit baseline at enrollment Liquid chromatography mass spectrometry analysis of midstream urine to compare metabolite features and pathway profiles between OAB and non OAB groups

Countries

Thailand

Contacts

Public ContactApisith Saraluck

Faculty of Medicine Ramathibodi Hospital, Mahidol University

apisith.sar@mahidol.ac.th66869616002

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026