The Estrogen Impact on Overactive Bladder Syndrome: Female Pelvic Floor Microbiomes and Antimicrobial Peptides

Completed · Not applicable

Conditions studied: Overactive Bladder

In brief

The medical field is beginning to adopt treatments that alter an individual's microbiome to improve patient health; however, this approach has not been adopted for treatment of lower urinary tract symptoms (LUTS). Here, the investigators propose the first step in development of such a therapy. If the investigators hypothesis is correct, the investigators could change the first line of treatment for hypoestrogenic women and develop future therapies that modulate bacteria in the bladder to improve not only LUTS but also treatment response. This could lead to the first treatment for lower urinary disorders that incorporates a person's individual microbiome.

Key facts

Study ID

NCT02524769

Run by

Loyola University

People needed

27

Starts

2015-12-01

Expected to finish

2017-06-01

Last updated by the study team

2021-04-15

Who can join

Age: 55 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of Overactive bladder
• Clinical diagnosis of Postmenopausal:
• English language skills sufficient to complete questionnaires
• Clinical indication for vaginal estrogen use
• Not currently receiving vaginal estrogen therapy

You may not qualify if…

• Currently on systemic hormone replacement therapy (HRT) Have been on HRT within the past three months
• Clinical diagnosis of estrogen dependent malignancies
• Allergy to local estrogen therapy
• Insufficient language skills to complete study questionnaires
• Women with active, urinary tract infection
• Received antibiotics within the past two weeks
• Clinical diagnosis of stage 3 or 4 pelvic organ prolapse
• Patient unwilling to use vaginal estrogen preparation
• Currently on anticholinergic medication Have received anticholinergic medication within the past three months
• Previously failed two medications for treatment of OAB Previously received intra-vesicle botulinum toxin injections Previously had posterior tibial nerve stimulation Previously had implantation of sacral neuromodulator
• Patients wishing to start anticholinergic medication at the initial encounter
• Undiagnosed abnormal genital bleeding
• Clinical diagnosis of deep vein thrombosis (DVT) Clinical diagnosis of pulmonary embolism (PE)
• Clinical diagnosis of arterial thromboembolic disease
• Clinical diagnosis of liver dysfunction or disease
• Clinical diagnosis of protein C, protein S or antithrombin or deficiency other known thrombophilic disorders

Where it is running

• Loyola University Medical Center — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

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