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| Name | Class |
|---|---|
| University of Maryland | OTHER |
| University of Connecticut | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Probiotic Arm | Experimental | BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) is offered over the counter. It contains a total of 5 billion lactobacilli: L. crispatus, L. gasseri, L. jensenii, and L. rhamnosus. RestoreTM gel: moisturizing personal lubricant. We will recommend to participants to use the probiotic supplement and vaginal lubricant as a vaginal suppository three times weekly at night for 3 months. |
|
| Standard Care Arm | Other | Women will perform standard care which includes follow up at 3 months for pessary removal/care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Floor Disability Index (PFDI-20) | The PFDI-20 will be used in order to evaluate pelvic floor symptoms. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Sappenfield, MD | Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37493229 | Derived | Sappenfield EC, Mellen C, Wilcox J, O'Hanlon DE, O'Sullivan DM, Tunitsky-Bitton E. The Impact of Vaginal Probiotics on Pessary Use: A Randomized Controlled Trial. Urogynecology (Phila). 2024 Jan 1;30(1):50-58. doi: 10.1097/SPV.0000000000001379. Epub 2023 Jul 18. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Participants will be randomized to the treatment arm versus standard care arm.
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Investigators performing vaginal specimens are blinded to treatment arm.
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| Standard Care | Other | Standard care arm is standard care for pessary use. Pessary maintenance will be performed standardly by their provider. |
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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. |
| 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. | 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. | 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) | 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. | Vaginal specimens will be collected for cytokine analysis at enrollment and after 3 months |
| Incidence of adverse events (safety and tolerability) | number of adverse events (vaginal irritation) | from enrollment to 3 month follow up visit |