Clinical trial NCT04118049: Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment
Official title: The Effect of Vaginal Probiotics on the Vaginal Microenvironment in Patients Using Vaginal Pessaries: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Inflammatory Response
Dysbiosis
Keywords: Pessary use
Probiotics
Cytokines
Microenvironment
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: University of Maryland
name: University of Connecticut
First posted: 2019-10-07
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to the treatment arm versus standard care arm.
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in vaginal microenvironment
timeFrame: Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment.
Secondary outcomes:
measure: Pelvic Floor Disability Index (PFDI-20)
timeFrame: Participants will complete the PFDI-20 upon enrollment and after 3 months of treatment.
measure: Vaginal probiotic feasibility, compliance with, and side effects of probiotic use.
timeFrame: Participants will complete after 1 month of use as well as at 3 months.
measure: Urinary tract infection incidence
timeFrame: During participant involvement in the study 3-4 months.
measure: BVAB-1
timeFrame: Vaginal specimen will collect from participants upon enrollment and after 3 months.
measure: Pro-inflammatory cytokines (Interleukin (IL-6)), Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin(IL-1alpha) and Interleukin (IL-1beta)
timeFrame: Vaginal specimens will be collected for cytokine analysis at enrollment and after 3 months
measure: Incidence of adverse events (safety and tolerability)
timeFrame: from enrollment to 3 month follow up visit
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Elisabeth Sappenfield, MD
role: PRINCIPAL_INVESTIGATOR
References: