Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse; Inflammatory Response; Dysbiosis
• Interventions: Other: Standard Care; Other: BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.

• Registration Number: NCT04118049
• Lead Sponsor: Hartford Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-07
• Study Start: 2019-10-30
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care Arm	Standard Care	Women will perform standard care which includes follow up at 3 months for pessary removal/care.
Vaginal Probiotic Arm	BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
Incidence of adverse events (safety and tolerability)	from enrollment to 3 month follow up visit	number of adverse events (vaginal irritation)
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.
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.

Trial Locations

Locations (1)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States