Clinical trial NCT04090190: Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics
Official title: Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Urgency Urinary
Keywords: Urinary Incontinence
Urgency Urinary
Anticholinergic Treatment
Urinary Microbiome
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Medical University of Silesia
First posted: 2019-09-16
Enrollment: 20
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: The Effectiveness of Anticholinergic Treatment in Relation to the Urinary Microbiome. Culture to Standard Culture Media Will Pickup Aerobic Bacteria and Yeasts After DNA Extraction and End Point PCR for 16S rDNA Genes.
timeFrame: At the 6 week mark
measure: The Urogenital Distress Inventory (UDI-6) Questionnaire Will be Used to Assess Baseline Urinary Symptoms Prior to Anticholinergic Treatment. Participants Indicate How Long They Have Had These Symptoms.
timeFrame: Baseline visit (0 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Vatche Minassian, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Pearce MM, Zilliox MJ, Rosenfeld AB, Thomas-White KJ, Richter HE, Nager CW, Visco AG, Nygaard IE, Barber MD, Schaffer J, Moalli P, Sung VW, Smith AL, Rogers R, Nolen TL, Wallace D, Meikle SF, Gai X, Wolfe AJ, Brubaker L; Pelvic Floor Disorders Network. The female urinary microbiome in urgency urinary incontinence. Am J Obstet Gynecol. 2015 Sep;213(3):347.e1-11. doi: 10.1016/j.ajog.2015.07.009. Epub 2015 Jul 23.
citation: Thomas-White KJ, Hilt EE, Fok C, Pearce MM, Mueller ER, Kliethermes S, Jacobs K, Zilliox MJ, Brincat C, Price TK, Kuffel G, Schreckenberger P, Gai X, Brubaker L, Wolfe AJ. Incontinence medication response relates to the female urinary microbiota. Int Urogynecol J. 2016 May;27(5):723-33. doi: 10.1007/s00192-015-2847-x. Epub 2015 Sep 30.