Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

Pelvic Organ Prolapse Clinical Trial

Official title:

The Effect of Vaginal Probiotics on the Vaginal Microenvironment in Patients Using Vaginal Pessaries: a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118049
• Other study ID #: R-HHC-2019-0069
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: March 2022
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysbiosis
• Inflammatory Response
• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• BiopHreshTM 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.
• Standard Care
Standard care arm is standard care for pessary use. Pessary maintenance will be performed standardly by their provider.

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Hartford Hospital	University of Connecticut, University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	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.	Participants will complete after 1 month of use as well as at 3 months.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	Incidence of adverse events (safety and tolerability)	number of adverse events (vaginal irritation)	from enrollment to 3 month follow up visit