At a glance
ClinicalIndex Comparison Record- ✓Women with overactive bladder symptoms (urgency, with or without urgency incontinence, usually with frequency and nocturia) and atrophic vaginitis
- ✓Postmenopausal status (≥12 months since last menstrual period, surgical menopause with bilateral oophorectomy, or age >55 with prior hysterectomy without bilateral oophorectomy)
- ✓Clinical indication for vaginal estrogen use with hypoestrogenic findings on physical examination
- ✓Not currently receiving vaginal estrogen therapy
- ✕Currently on systemic hormone replacement therapy (HRT) or within past 3 months
- ✕Current or prior history of estrogen-dependent malignancies (breast or endometrial cancer)
- ✕Contraindication or allergy to estrogen therapy
- ✕Active, culture-positive urinary tract infection or urine dip positive for leukocytes and nitrates on straight catheterized sample at baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Investigation of the Effect of the Female Urinary Microbiome on Incontinence
In Brief
A Phase 4 clinical trial evaluating Estrogen Cream for Overactive Bladder and 2 related conditions. Completed, enrolled 35 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.