Vaginal Microbiome Changes in Pessary Users

Overview

About this study

The purpose of this study is to comprehensively investigate the impact of pessary use on the vaginal microbiome and bothersome vaginal discharge in women with pelvic organ prolapse (POP). The study will focus on new users of pessary

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Females who are English speaking and are at least 18 years of age.
  • Menopausal status
  • 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
  • Those who are consenting and able to participate in the follow up and complete the questionnaire.

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
  • Receiving immunosuppressive therapy or history of immunodeficiency
  • Presence of an indwelling vascular access line or structural heart disease
  • Within 6 weeks (about 1 and a half months) from any abdominal or pelvic surgery or other major surgery
  • Currently using probiotics
  • Currently using antibiotics or used within 4 weeks of initial vaginal swab
  • Having BV or vaginitis at the time of recruitment

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/17/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Occhino, M.D., M.S.

Open for enrollment

Contact information:

Sujatha Narayanamoorthy M.B.B.S.

(507) 266-0167

Narayanamoorthy.Sujatha@mayo.edu

More information

Publications

Publications are currently not available