Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics
Overview
- Phase
- Phase 4
- Intervention
- Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine
- Conditions
- Urinary Incontinence
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Vatche Arakel Minassian
Chief, Division of Urogynecology. Associate Professor, Harvard Medical Schoo
Brigham and Women's Hospital
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)
Arms & Interventions
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
Intervention: Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine
Outcomes
Primary Outcomes
Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Time Frame: 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 Outcomes
- 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))
- 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)