Investigation of the Effect of the Female Urinary Microbiome on Incontinence

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This purpose of this study is to understand the types of bacteria that are in the bladder and vagina in patients with overactive bladder (OAB) symptoms and understand if the types of bacteria change when with the use of estrogen in the vagina. The investigators are also trying to understand how estrogen influences the body's ability to make substances called peptides that can kill bacteria.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Women who present with symptoms of OAB, defined as a condition characterized by urgency, with or without urgency incontinence, usually with frequency and nocturia in the absence of obvious pathology or infection \[9\], with atrophic vaginitis.

• Postmenopausal by history (i.e., defined as twelve months or greater since last menstrual period), surgical menopause with removal of bilateral ovaries, or age over 55 with a previous hysterectomy (without removal of bilateral ovaries).

• English language skills sufficient to complete questionnaires

• Clinical indication for vaginal estrogen use (i.e., hypoestrogenic findings on physical examination)

• Patients not currently receiving vaginal estrogen therapy

Locations
United States
Illinois
Loyola University Medical Center
Maywood
Time Frame
Start Date: 2016-09
Completion Date: 2018-05
Participants
Target number of participants: 35
Treatments
Experimental: Estrogen Arm
The intervention for this study is an estrogen cream (i.e., Premarin Cream®). Women in this study will receive this estrogen cream and apply it to their vagina twice weekly for 12 weeks
Authors
Alan Wolfe, Cynthia Brincat
Sponsors
Leads: Loyola University
Collaborators: Kimberly-Clark Corporation

This content was sourced from clinicaltrials.gov