Dysbiosis, Inflammatory Response, Pelvic Organ Prolapse
Conditions
Keywords
Pessary use, Probiotics, Cytokines, Microenvironment
Brief summary
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).
Interventions
OTHERBiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.
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.
OTHERStandard Care
Standard care arm is standard care for pessary use. Pessary maintenance will be performed standardly by their provider.
Sponsors
University of Maryland
University of Connecticut
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
Investigators performing vaginal specimens are blinded to treatment arm.
Intervention model description
Participants will be randomized to the treatment arm versus standard care arm.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vaginal microenvironment | Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment. | Change in vaginal microenvironment on gram stain measuring lactobacilli, anaerobic bacteria, and mobiluncus, WBCs and epithelial cell maturation reported as Nugent Subscore. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal probiotic feasibility, compliance with, and side effects of probiotic use. | Participants will complete after 1 month of use as well as at 3 months. | 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. |
| Urinary tract infection incidence | During participant involvement in the study 3-4 months. | Occurrences of urinary tract infections during the study period will be monitored. |
| Pelvic Floor Disability Index (PFDI-20) | Participants will complete the PFDI-20 upon enrollment and after 3 months of treatment. | The PFDI-20 will be used in order to evaluate pelvic floor symptoms. |
| Pro-inflammatory cytokines (Interleukin (IL-6)), Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin(IL-1alpha) and Interleukin (IL-1beta) | Vaginal specimens will be collected for cytokine analysis at enrollment and after 3 months | Pro-inflammatory cytokines will be evaluated from vaginal specimens collected in order to evaluate (1) the impact of probiotics on the inflammatory environment of the vagina (2) longitudinal assessment of pro-inflammatory cytokines in pessary wearing patients. |
| Incidence of adverse events (safety and tolerability) | from enrollment to 3 month follow up visit | number of adverse events (vaginal irritation) |
| BVAB-1 | Vaginal specimen will collect from participants upon enrollment and after 3 months. | Evaluate the incidence of BVAB-1 and impact of vaginal probiotics on BVAB-1 in postmenopausal women via gram stain. |
Countries
United States
Outcome results
None listed