Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

Urinary Incontinence Clinical Trial

Official title:

Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04090190
• Other study ID #: 2018P000980
• Status: Completed
• Phase: Phase 4
• Start date: October 30, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: October 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 31, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Enuresis
• Inflammation
• Urgency Urinary
• Urinary Incontinence

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Medical University of Silesia

Country where clinical trial is conducted

United States, 

References & Publications (7)

Cho I, Blaser MJ. The human microbiome: at the interface of health and disease. Nat Rev Genet. 2012 Mar 13;13(4):260-70. doi: 10.1038/nrg3182. Review. — View Citation

Hilt EE, McKinley K, Pearce MM, Rosenfeld AB, Zilliox MJ, Mueller ER, Brubaker L, Gai X, Wolfe AJ, Schreckenberger PC. Urine is not sterile: use of enhanced urine culture techniques to detect resident bacterial flora in the adult female bladder. J Clin Microbiol. 2014 Mar;52(3):871-6. doi: 10.1128/JCM.02876-13. Epub 2013 Dec 26. — View Citation

Hu TW, Wagner TH, Bentkover JD, Leblanc K, Zhou SZ, Hunt T. Costs of urinary incontinence and overactive bladder in the United States: a comparative study. Urology. 2004 Mar;63(3):461-5. — View Citation

Molinuevo B, Batista-Miranda JE. Under the tip of the iceberg: psychological factors in incontinence. Neurourol Urodyn. 2012 Jun;31(5):669-71. doi: 10.1002/nau.21216. Epub 2012 Mar 30. Review. — View 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. — View 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. — View Citation

Thomas-White KJ, Kliethermes S, Rickey L, Lukacz ES, Richter HE, Moalli P, Zimmern P, Norton P, Kusek JW, Wolfe AJ, Brubaker L; National Institute of Diabetes and Digestive and Kidney Diseases Urinary Incontinence Treatment Network. Evaluation of the urinary microbiota of women with uncomplicated stress urinary incontinence. Am J Obstet Gynecol. 2017 Jan;216(1):55.e1-55.e16. doi: 10.1016/j.ajog.2016.07.049. Epub 2016 Aug 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.	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.	Baseline and 6 weeks
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.	The change in g_lactobacillus from Baseline to Follow-up (6 weeks), which corresponds to before and after anticholinergic treatment.	At the 6 week mark
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.	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.	Baseline visit (0 weeks)