Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

NCT04090190 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2018P000980
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Urgency Urinary

Keywords

Urinary Incontinence; Urgency Urinary; Anticholinergic Treatment; Urinary Microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 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)

Study Arms (1)

standard of care anticholinergic treatment

OTHER

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

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

Interventions

Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine DRUG

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.

Also known as: Ditropan, Vesicare, Detrol, Sanctura, Toviaz

standard of care anticholinergic treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Medical University of Silesia: collaborator

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (7)

• 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.

  PMID: 22473905 BACKGROUND

• 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. doi: 10.1016/j.urology.2003.10.037.

  PMID: 15028438 BACKGROUND

• 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.

  PMID: 22411464 BACKGROUND

• 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.

  PMID: 24371246 BACKGROUND

• 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.

  PMID: 27498309 BACKGROUND

• 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.

  PMID: 26210757 BACKGROUND

• 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.

  PMID: 26423260 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Interventions

oxybutynin; Solifenacin Succinate; Tolterodine Tartrate; trospium chloride; fesoterodine

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Results Point of Contact

• Title: Vatche Minassian, MD, MPH
• Organization: Mass General Brigham

vminassian@bwh.harvard.edu

(617) 732-4838

Study Officials

• Vatche Minassian, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Urogynecology. Associate Professor, Harvard Medical Schoo

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: September 16, 2019
• Study Start: October 30, 2019
• Primary Completion: May 30, 2021
• Study Completion: October 31, 2021
• Last Updated: November 15, 2022
• Results First Posted: October 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)