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Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

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ClinicalTrials.gov Identifier: NCT04090190
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
Medical University of Silesia
Information provided by (Responsible Party):
Vatche Arakel Minassian, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Urgency Urinary Drug: Oxybutynin, Solifenacin, Tolterodine, Sanctura or Toviaz Not Applicable

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 clean catch urine sample and blood draw. Study participants will fill out a Urinary Distress Inventory-6 (UDI-6) questionnaire at baseline and keep a bladder diary before starting the anticholinergic medication.

The urine will be assessed by enhanced urine cultures and DNA sequencing for urinary microbiome along with inflammatory mediators in the urine. Inflammatory mediators in both the blood and urine will be measured using immuonenzyme 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Oxybutynin, Solifenacin, Tolterodine, Sanctura or Toviaz
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.




Primary Outcome Measures :
  1. The change in the urinary microbiome with inflammatory changes in postmenopausal women with UUI. Culture to standard culture media will pickup aerobic bacteria and yeasts after DNA extraction and end point PCR for 16S rDNA genes. [ Time Frame: 6 weeks ]
  2. The change in the urinary microbiome with immune changes in postmenopausal women with UUI. Culture to standard culture media will pickup aerobic bacteria and yeasts after DNA extraction and end point PCR for 16S rDNA genes. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 6 weeks ]
  2. The Urogenital Distress Inventory (UDI-6) questionnaire will be used to assess changes in urinary symptoms after 6-weeks of anticholinergic treatment. Participants indicate which symptoms they are experiencing and how bothersome they are. [ Time Frame: 6 weeks ]
  3. Inflammatory mediators in blood and urine will be measured using immunoenzyme assays to measure the interaction of anticholinergic treatment and the inflammatory milieu. [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal (Age ≥ 50) women with 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
  • UTI in the last three months
  • Neurological disease (eg. Parkinson's disease, MS, etc.)
  • Immunological deficiencies
  • History of STDs
  • Lack of consent
  • Not ambulatory (e.g. uses a wheelchair)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090190


Contacts
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Contact: Vatche A Minassian, MD, MPH 617-732-4838 vminassian@bwh.harvard.edu
Contact: Talar Abdalian, MS, BS 617-732-6281 tabdalian@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Vatche A Minassian, MD, MPH    617-732-4838    vminassian@bwh.harvard.edu   
Contact: Talar Abdalian, MS    617-732-6281    tabdalian@bwh.harvard.edu   
Principal Investigator: Vatche A Minassian, MD, MPH         
Sub-Investigator: Jeannine M Miranne, MD, MS         
Sponsors and Collaborators
Brigham and Women's Hospital
Medical University of Silesia

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Responsible Party: Vatche Arakel Minassian, Chief, Division of Urogynecology. Associate Professor, Harvard Medical Schoo, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04090190    
Other Study ID Numbers: 2018P000980
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vatche Arakel Minassian, Brigham and Women's Hospital:
Urinary Incontinence
Urgency Urinary
Anticholinergic Treatment
Urinary Microbiome
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Inflammation
Pathologic Processes
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Solifenacin Succinate
Tolterodine Tartrate
Oxybutynin
Cholinergic Antagonists
Muscarinic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents