Inflammatory proteins in the urine and bladder tissue of women with lower urinary tract symptoms

Urinary and bladder cytokine expression in women with lower urinary tract symptoms

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN82797589

Enrollment

Registered

2024-11-28

Start date

2023-08-01

Completion date

Unknown

Last updated

2025-01-06

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

Conditions

Identifying and understanding inflammatory changes in the urine and bladder tissue of women with chronic lower urinary tract symptoms Urological and Genital Diseases

Interventions

Women recruited for this study will be asked to fill out three validated symptom questionnaires about their chronic lower urinary tract symptoms: 1) The O'Leary Sant Interstitial Cystitis Index (ICSI)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women with significantly bothersome lower urinary tract symptoms lasting for over 3 months 2. Women who are already undergoing cystoscopy and bladder biopsy under a general anaesthetic for the investigation of lower urinary tract symptoms 3. Women aged 18 or older 4. Women with the capacity to consent to take part in research themselves 5. Women able to complete validated symptom questionnaires in English 6. Women who have signed a valid written consent form for the provision of extra samples for research under the Imperial College Healthcare Tissue Bank Ethics

Exclusion criteria

Exclusion criteria: 1. Women under the age of 18 years 2. Women who are unable to complete validated questionnaires in English 3. Women without capacity to consent themselves for research 4. Women who have undergone previous continence procedures 5. Women with a history of urological malignancy 6. Women undergoing current treatment for urological malignancy

Design outcomes

Primary

Measure	Time frame
Inflammatory cytokine expression in urine and bladder tissue measured at the time of cystoscopy using a sterile sample of urine and two extra bladder biopsies. Multiplex sandwich ELISA assaying techniques are used for the detection of a panel of inflammatory cytokines in the paired urine and bladder tissue samples and compared with healthy controls without chronic urinary tract symptoms.	—

Secondary

Measure	Time frame
Chronic lower urinary tract symptoms measured at baseline 1. The O'Leary Sant Interstitial Cystitis Index (ICSI) 2. The King's Health Questionnaire (KHQ) 3. The international Consultation on Incontinence Questionnaire-female lower urinary tract symptom modules (ICIQ-fluts)	—

Countries

England, United Kingdom

Contacts

Public ContactBernadette Lemmon

blemmon@nhs.net07961949624

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026