Investigation of the Effect of the Female Urinary Microbiome on Incontinence
Condition: Overactive Bladder; Incontinence; Nocturia
MeSH terms: Urinary Bladder, Overactive; Nocturia
Intervention: Estrogen Cream
Intervention description: Participants are provided a vaginal estrogen cream (i.e., Premarin Cream® 0.625 mg conjugated estrogen/gram) and instructed to use 0.5 grams with an applicator twice weekly for 12 weeks.
Intervention MeSH terms: Estrogens
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Overactive Bladder Syndrome; Female Urinary Microbiome; Urinary Urgency; Estrogen; Nocturia; Incontinence

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 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