Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

Phase 4

Completed

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

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
standard of care anticholinergic treatment	Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine	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

Primary Outcome Measures

Name	Time	Method
Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.	Baseline and 6 weeks	Statistical testing was used to determine if there was a difference in inflammatory markers in the urine of patients between baseline visit and 6 week visit. 7 markers were chosen and compared, all inflammatory markers present in urine.

Secondary Outcome Measures

Name	Time	Method
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.	Baseline visit (0 weeks)	Symptoms taken from the UDI-6, a validated questionnaire for urogynecologic symptoms, were gathered at baseline for all patients. Duration of Urinary Incontinence symptoms is presented.
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.	At the 6 week mark	The change in g_lactobacillus from Baseline to Follow-up (6 weeks), which corresponds to before and after anticholinergic treatment.