Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Urgency Urinary; Urinary Incontinence

Treatments: Drug: Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine

Study type: Interventional

Funder types: Other

Identifiers

NCT04090190

2018P000980

Details and patient eligibility

About

Urinary incontinence (UI) is a very common condition affecting women of all ages. The objective of this pilot study is to better understand the urinary microbiome and associated inflammatory markers in blood and urine in women with urgency UI. The study will assess how inflammation may affect response to standard of care anticholinergic medication treatment for urgency urinary incontinence.

Full description

This study is designed as a prospective pilot study of women presenting to the Urogynecology clinic with urgency urinary incontinence symptoms who are offered treatment with a standard of care anticholinergic medication for six weeks. The patient will be asked to provide a catheterized urine sample at baseline and 6 weeks and blood draw only at baseline. Study participants will fill out a Urinary Distress Inventory-6 (UDI-6) questionnaire at baseline and fill a bladder diary for 48 hours before starting the anticholinergic medication.

The urine will be assessed by standard and enhanced urine cultures and DNA amplification and 16S rRNA sequencing for urinary microbiome along with inflammatory markers in the urine. Inflammatory markers in both the blood and urine will be measured using immunoenzyme assays.

Measurements for microbiome will be repeated for all patients at 6 weeks. Baseline urinary symptoms at enrollment and variation of symptoms after 6 weeks of anticholinergic treatment will be assessed using the UDI-6 questionnaire and a bladder diary.

Enrollment: 20 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal (Age ≥ 50) women with Urgency Urinary Incontinence (UUI)
• English speaking
• Willing to take anticholinergics for at least 6 weeks
• Willing to complete UDI-6 and voiding diary at baseline and 6 weeks
• Willing to give urine and blood for study at baseline and 6 weeks

Exclusion criteria

• Have taken anticholinergic medication within the last month
• Have taken antibiotics within the last month
• Urinary Tract Infection (UTI) in the last three months
• Neurological disease (eg. Parkinson's disease, Multiple Sclerosis, etc.)
• Immunological deficiencies
• History of sexually transmitted disease (STD)
• Lack of consent
• Not ambulatory (e.g. uses a wheelchair)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

standard of care anticholinergic treatment

Other group

Description:

Women presenting to the Urogynecology clinic with urgency urinary incontinence symptoms will receive standard of care anticholinergic treatment and will have their urinary microbiome evaluated before and after treatment

Treatment:

Drug: Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine