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

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Treatments: Anti-Infective Agents; Estrogens; Estrogens, Conjugated (USP)

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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