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Completed

NCT Number: NCT04118049

Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

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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Key information

Conditions

Pelvic Organ Prolapse Dysbiosis Inflammatory Response Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hartford Hospital

Hartford, Connecticut, 06103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard care

Other

Standard care arm is standard care for pessary use. Pessary maintenance will be performed standardly by their provider.

Primary outcomes

  1. Change in vaginal microenvironment

    Time frame: 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 outcomes

  1. Pelvic Floor Disability Index (PFDI-20)

    Time frame: 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.

  2. Vaginal probiotic feasibility, compliance with, and side effects of probiotic use.

    Time frame: 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.

  3. Urinary tract infection incidence

    Time frame: During participant involvement in the study 3-4 months.

    Occurrences of urinary tract infections during the study period will be monitored.

  4. BVAB-1

    Time frame: 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.

  5. Pro-inflammatory cytokines (Interleukin (IL-6)), Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin(IL-1alpha) and Interleukin (IL-1beta)

    Time frame: 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.

  6. Incidence of adverse events (safety and tolerability)

    Time frame: from enrollment to 3 month follow up visit

    number of adverse events (vaginal irritation)

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • University of Connecticut
  • University of Maryland

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 7, 2019
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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