A Study to Analyze the Vaginal and Bladder Microbiome in Patients Undergoing Vaginal Estrogen or Vaginal LASER Therapy

Overview

About this study

The purpose of this study is to evaluate vaginal microbiome at baseline and at 3 months in menopausal women with either vaginal atrophy (with or without rUTI) or rUTI, following treatment of vaginal estrogen and LASER therapy, to evaluate the bladder microbiome at baseline and at 3 months in menopausal women with vaginal atrophy with rUTI undergoing treatment of vaginal estrogen or LASER therapy, and to compare the microbial communities between women who undergo vaginal estrogen with those who undergo LASER therapy.

 

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:

  • Menopausal women > 18 years old.
  • Recruited from the Department of Gynecology or Urology, who are undergoing vaginal estrogen or LASER treatment for either vaginal atrophy or rUTI.
  • Planned treatment of either vaginal estrogen or vaginal LASER therapy.
  • Postmenopausal status, documented by prior bilateral salpingo-oophorectomy, or absence of menses > 12 months.
  • Patients on vaginal estrogen must undergo a 1 month washout period prior to initiation of the trial.
  • Clinical diagnosis of vaginal atrophy with or without rUTI or recurrent UTI.

Exclusion Criteria: 

  • Hematuria without appropriate workup.
  • Pelvic organ prolapse at or beyond the hymen.
  • Incomplete bladder emptying defined by Post void residual > 150mL.
  • Pelvic reconstructive surgery within 6 months.
  • Prior synthetic mesh procedure for pelvic organ prolapse or urinary incontinence.
  • Current nephrolithiasis.
  • Prior urinary tract surgery, including surgery on the urethra, bladder, ureters or kidneys
  • History of breast cancer.
  • Contraindication to topical estrogen therapy.
  • Anticoagulation therapy.
  • Prior pelvic or vaginal radiation therapy.
  • Prior gynecologic malignancy.
  • Undiagnosed genital bleeding

 

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

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Johnny Yi, M.D.

Open for enrollment

Contact information:

Noel De Lucia B.S.

(480)342-1258

DeLucia.Noel@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20470196

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