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Phase 4 N=20 Treatment

Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

Urinary Incontinence · Urgency Urinary

Bottom Line

View on ClinicalTrials.gov: NCT04090190 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu. — 2.192; 2.565; 2.192; 2.565 pg/mL — p=0.6497

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine (Drug)
Age
Adult, Older Adult · 50+ yrs
Sex
Female
Sponsor
Brigham and Women's Hospital
Primary completion
May 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.		 2.192; 2.565; 2.192; 2.565; 75.49; 65.02 0.6497
SECONDARY
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.		 0.001131599 —
SECONDARY
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.		 8; 7; 4; 0; 1 —

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.

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04090190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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