Investigation of the Effect of the Female Urinary Microbiome on Incontinence

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Collaborator: Kimberly-Clark Corporation
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients currently on systemic hormone replacement therapy (HRT) or who have been on HRT within the past three months

• Patients with current diagnosis or history of estrogen dependent malignancies (e.g., breast or endometrial malignancies)

• Contraindication or allergy to estrogen therapy

• Insufficient English language skills to complete study questionnaires

• Women with active, standard culture positive urinary tract infection at baseline assessment, or those with a urine dip positive for leukocytes and nitrates on straight catheterized sample.

• Patients who have received antibiotics within the past two weeks

• Patients with stage 3 or 4 pelvic organ prolapse based on the pelvic organ prolapse quantitation system (POP-q)

• Patients unwilling to use vaginal estrogen preparation

• Patients currently on anticholinergic medications or who have received anticholinergic medications within the past three months

• Patients who have previously failed two medications for treatment of OAB or have previously received more advanced treatment for OAB including intra-vesicle botulinum toxin injections, posterior tibial nerve stimulation, or implantation of a sacral neuromodulator

• Patients wishing to start anticholinergic medication at the initial encounter

• Undiagnosed abnormal genital bleeding

• Active deep vein thrombosis (DVT), pulmonary embolism (PE), or a history of these conditions

• Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions

• Known liver dysfunction or disease

• Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders