N/A N=27 Treatment

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

Overactive Bladder

Bottom Line

View on ClinicalTrials.gov: NCT02524769 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Change in the Relative Abundance of Lactobacillus — 0.143 proportion of total microbes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: conjugated estrogen (Drug)
Age: Adult, Older Adult · 55+ yrs
Sex: Female
Sponsor: Loyola University
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Relative Abundance of Lactobacillus	0.143	—
SECONDARY Change in OAB Symptoms	-23	—
SECONDARY OAB Symptoms Associated With Relative Abundance of Lactobacillus	-0.59	—
SECONDARY Change in Urothelial Antimicrobial Peptide (AMP) Levels	-0.11	—
SECONDARY Change in OAB Symptoms Associated With Change in AMP Levels	0.60	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02524769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.