Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2021-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Incontinence Urgency Urinary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard of care anticholinergic treatment

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

Group Type OTHER

Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine

Intervention Type DRUG

Study participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.

Interventions

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Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine

Study participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.

Intervention Type DRUG

Other Intervention Names

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Ditropan Vesicare Detrol Sanctura Toviaz

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No