NCT04301934

Brief Summary

Randomized controlled trial to determine clinical and microbiome difference between fractional CO2 Laser and vaginal estrogen in treating patients with recurrent urinary tract infection (UTI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 26, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

March 6, 2020

Results QC Date

March 1, 2024

Last Update Submit

March 1, 2024

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Urinary Tract Infections (UTI)

    Prevalence of urinary tract infections (UTI) described as percentage of subjects with none vs one or more UTI.

    4 months

Study Arms (2)

Vaginal Estrogen Therapy Group

ACTIVE COMPARATOR

Women randomized to vaginal estrogen therapy will be offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly

Drug: Conjugated estrogenDrug: Estradiol

Laser Therapy Group

EXPERIMENTAL

Women randomized to the laser therapy group will undergo 3 treatments, 6 weeks apart.

Device: Mona Lisa Touch

Interventions

Mona Lisa TouchDEVICE

Fractional CO2 LASER

Laser Therapy Group
Conjugated estrogenDRUG

Current standard treatment for recurrent UTIs in postmenopausal women

Also known as: Premarin
Vaginal Estrogen Therapy Group
EstradiolDRUG

Current standard treatment for recurrent UTIs in postmenopausal women

Also known as: Estrace
Vaginal Estrogen Therapy Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Estrogens, Conjugated (USP)Estradiol

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Johnny Yi, M.D.
Organization
Mayo Clinic
Yi.Johnny@mayo.edu
480-342-0612

Study Officials

  • Johnny Yi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

June 1, 2020

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

March 26, 2024

Results First Posted

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)