Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

Hartford Hospital141 enrolled

Overview

In this study, the investigators are evaluating the effect of vaginal probiotics on the bothersome side effects of pessary use and the impact on the vaginal microenvironment (lactobacilli, anaerobic bacteria, mobiluncus bacteria, WBCs, cellular debris, epithelial cells, and BVAB-1), and inflammatory environment (cytokines).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

141

Conditions

Pelvic Organ Prolapse Inflammatory Response Dysbiosis

Interventions

BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.OTHER

BiopHreshTM is a vaginal probiotic supplement that is offered over the counter and contains four different lactobacilli strains (L. crispatus, L. gasseri, L. jensenii, and L. rhamnosus). RestoreTM is a moisturizing personal lubricant that has been on the market for three years. Participants will use 1 probiotic capsule with RestoreTM gel nightly three times weekly.

Standard CareOTHER

Standard care arm is standard care for pessary use. Pessary maintenance will be performed standardly by their provider.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal (no menstruation \>12 months) * Subjects presenting for 2 week post initial pessary insertion appointment or presenting for routine pessary care follow up appointment * Planning on continuing to use a pessary for treatment for at least 3 months * Pessary maintenance performed by provider (as opposed to self-care) * Able to understand English * Able/willing to sign informed consent document Exclusion Criteria: * Lack of cognitive ability to consent to participate in study and to complete the questionnaires * Planned prolapse surgery less than 3 months from enrollment * Presence of vaginal fistulas * Pessary self-care (patient changes and cleans her own pessary) * Receiving immunosuppressive therapy or history of immunodeficiency * Presence of an indwelling vascular access line or structural heart disease * Within 6 weeks from any abdominal or pelvic surgery or other major surgery * Allergy to lactobacillus (contents of probiotic) * Allergy to beta-lactam antibiotics, erythromycin and clindamycin * Use of any probiotic pills, creams, or suppositories currently

Locations (1)

Hartford Hospital

Hartford, Connecticut, United States

Outcomes

Primary Outcomes

Change in vaginal microenvironment

Change in vaginal microenvironment on gram stain measuring lactobacilli, anaerobic bacteria, and mobiluncus, WBCs and epithelial cell maturation reported as Nugent Subscore.

Time frame: Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment.

Secondary Outcomes

Pelvic Floor Disability Index (PFDI-20)

The PFDI-20 will be used in order to evaluate pelvic floor symptoms.

Time frame: Participants will complete the PFDI-20 upon enrollment and after 3 months of treatment.

Vaginal probiotic feasibility, compliance with, and side effects of probiotic use.

Unvalidated questionnaires (vaginal products and hromonal therapy questionnaire, subjective vaginal experiences over the past month questionnaire, and a vaginal probiotic questionnaire) were created in order to evaluate participant experiences with vaginal probiotics including feasibility, impact on symptoms from pessary use, and side effects from use. These questionnaires do not have scales.

Time frame: Participants will complete after 1 month of use as well as at 3 months.

Urinary tract infection incidence

Occurrences of urinary tract infections during the study period will be monitored.

Time frame: During participant involvement in the study 3-4 months.

BVAB-1

Evaluate the incidence of BVAB-1 and impact of vaginal probiotics on BVAB-1 in postmenopausal women via gram stain.

Time frame: Vaginal specimen will collect from participants upon enrollment and after 3 months.

Pro-inflammatory cytokines (Interleukin (IL-6)), Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin(IL-1alpha) and Interleukin (IL-1beta)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.