A Study to Evaluate Feasibility of Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection

Overview

About this study

The purpose of this study is to evaluate the clinical difference between the LASER and topical vaginal estrogen in treating patients with recurrent urinary tract infections (rUTI). 

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:

  • Female patient > 18 years old.
  • Postmenopausal status, documented by prior bilateral salpingo-oophorectomy, or absence of menses >12 months.
  • Recurrent urinary tract infections as defined by 3 culture positive urine cultures in the last 12 months, or 2 positive urine cultures in the last 6 months.
  • Positive urine cultures defined by > 100K colony forming units of 1 or 2 bacterial species on clean catch sample, or > 1000 colony forming units of 1 or 2 bacterial species on sample via straight catheterization.
  • Patients on vaginal estrogen must undergo a 1 month washout period prior to initiation of the trial.

Exclusion Criteria:

  • Hematuria without appropriate workup.
  • Pelvic organ prolapse at or beyond the hymen.
  • Clinically relevant urinary retention.
  • Pelvic reconstructive surgery within 6 months.
  • Prior synthetic mesh procedure for pelvic organ. prolapse or urinary incontinence.
  • Clinically relevant nephrolithiasis.
  • 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

Jacksonville, Fla.

Mayo Clinic principal investigator

Anita Chen, M.D.

Closed for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Johnny Yi, M.D.

Closed for enrollment

Contact information:

Sonia Velazquez

(480) 342-6677

Robertson.Sonia@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20473262

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