Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women (VESPR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01958073
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Collaborators:
American Urogynecologic Society
NYU Langone Health
Information provided by (Responsible Party):
Kimberly Ferrante, MD, NYU Langone Health

Brief Summary:
The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).

Condition or disease Intervention/treatment Phase
Recurrent Urinary Tract Infection Drug: Conjugated Estrogen Vaginal Cream Drug: Estradiol Ring Drug: Placebo Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized Clinical Trial
Study Start Date : October 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Conjugated Estrogen Vaginal Cream
Conjugated estrogen vaginal cream 0.5g per vagina 2 times weekly
Drug: Conjugated Estrogen Vaginal Cream
Experimental: Estradiol Ring
Estradiol Ring per vagina every 3 months
Drug: Estradiol Ring
Placebo Comparator: Placebo
Per vagina
Drug: Placebo



Primary Outcome Measures :
  1. Occurrence of UTI During Randomization [ Time Frame: 6 months of the randomized period ]
    The primary purpose of this study is to assess the efficacy of vaginal estrogen versus placebo at 6 months on the prevention of urinary tract infections (UTI) in postmenopausal women with history of recurrent UTI.


Secondary Outcome Measures :
  1. Rates of UTI in Both Randomization Period and Within Placebo When Changed to Open Label Estrogen [ Time Frame: Assessed at 6 months for 'a'; assessed over 12 months for 'b' ]
    1. To assess overall rates of UTI over 6 months in postmenopausal women with history of recurrent UTI receiving vaginal estrogen (ring or cream).
    2. To compare rates of UTI between 6 and 12 months of those subjects initially randomized to placebo.

  2. Quality of Life Questionnaire: Female Sexual Function Index [ Time Frame: 6 months of the randomized period ]
    To assess the impact of treatment of recurrent UTI with vaginal estrogen on quality of life at 6 months in postmenopausal women with history of recurrent UTI. Female Sexual Function Index. Scale range 2-95. Lower score corresponds to worse functioning.

  3. Compliance During Randomization [ Time Frame: 6 months of the randomized period ]
    To assess compliance with vaginal estrogen (ring or cream) treatment at 6 months in postmenopausal women with history of recurrent UTI.

  4. Occurrence of UTI in Those Compliant With Treatment During Randomization [ Time Frame: 6 months of the randomized period ]
    To assess efficacy of vaginal estrogen at 6 months in those compliant with treatment.

  5. Quality of Life Questionnaire: MESA I [ Time Frame: 6 months of the randomized period ]
    To assess the impact of treatment of recurrent UTI with vaginal estrogen on quality of life at 6 months in postmenopausal women with history of recurrent UTI. Medical, Epidemiologic, and Social Aspects of Aging Questionnaire (MESA) urinary incontinence questionnaire: stress urinary incontinence subscale. Subscale range 0-27. A higher score indicated more frequent symptoms.

  6. Quality of Life Questionnaire: MESA II [ Time Frame: 6 months of the randomized period ]
    To assess the impact of treatment of recurrent UTI with vaginal estrogen on quality of life at 6 months in postmenopausal women with history of recurrent UTI. Medical, Epidemiologic, and Social Aspects of Aging Questionnaire (MESA) urinary incontinence questionnaire: urgency urinary incontinence subscale. Subscale range 0-18. High score indicates more frequent symptoms.

  7. Quality of Life Questionnaire: Pelvic Floor Disability Index [ Time Frame: 6 months of the randomized period ]
    To assess the impact of treatment of recurrent UTI with vaginal estrogen on quality of life at 6 months in postmenopausal women with history of recurrent UTI. Pelvic Floor Disability Index. Scale range 0-100. Higher score corresponds to increased bother.

  8. Quality of Life Questionnaire: Pelvic Floor Impact Questionnaire [ Time Frame: 6 months of the randomized period ]
    To assess the impact of treatment of recurrent UTI with vaginal estrogen on quality of life at 6 months in postmenopausal women with history of recurrent UTI. Pelvic Floor Impact Questionnaire. Scale range 0-300. Higher score corresponds to increasing bother.

  9. Quality of Life Questionnaire: Estimated Percentage of Improvement [ Time Frame: 6 months of the randomized period ]
    To assess the impact of treatment of recurrent UTI with vaginal estrogen on quality of life at 6 months in postmenopausal women with history of recurrent UTI. Estimated Percentage of Improvement. Scale range 0-100. Higher score corresponds to more improvement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Postmenopausal status as defined by amenorrhea for >12 months, OR history of bilateral salpingoophrectomy, OR if the patient has had a hysterectomy defined by menopausal symptoms for >1 year OR age >55
  2. Documented recurrent UTIs (3 or more in the last year or 2 or more in the last 6 months)- one UTI must be documented by culture, others may be documented by urinalysis
  3. Ability to provide informed consent

Exclusion Criteria:

  1. Use of any investigational drug or device within thirty days of screening
  2. Urologic surgery within the past 3 months of screening or plan for surgery within one year of screening
  3. Diagnosis of Interstitial Cystitis/painful bladder syndrome
  4. History of urinary tract infections which require the use of IV antibiotics or where only one oral antibiotic is available for treatment, or where the risk of treatment with vaginal estrogen only is deemed unacceptable by the principle investigator secondary to the severity of prior urinary tract infections
  5. Known etiology of infection such as, but not limited to: kidney or bladder stones, enterovaginal/vesical fistula, fecal incontinence, intermittent catheterization, indwelling catheter, poorly controlled diabetes
  6. Urothelial cancer
  7. Actively treated estrogen sensitive tumor (breast or endometrial cancer)
  8. Undiagnosed vaginal bleeding
  9. Inability to use a vaginal ring (secondary to advanced prolapse or shortened vaginal length)
  10. Any medical reason the investigator deems incompatible with treatment with vaginal estrogen
  11. Prolapse requiring pessary use

Deferral Criteria

  1. Undiagnosed hematuria - may enroll after malignancy is ruled out
  2. Use of a progestin containing intrauterine device or use of any vaginal androgens, estrogens or progestins within 3 months of enrollment - may enroll after wash out
  3. Use of drugs/supplements known to prevent UTIs (ie cranberry products, prophylactic antibiotics, methenamine hippurate) 1 month prior to enrollment - may enroll after wash out if still meets inclusion criteria.
  4. History of estrogen sensitive tumor (breast or endometrial cancer) - requires approval by the subject's primary oncologist or primary care physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958073


Locations
Layout table for location information
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
University of California, San Diego
American Urogynecologic Society
NYU Langone Health
  Study Documents (Full-Text)

Documents provided by Kimberly Ferrante, MD, NYU Langone Health:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kimberly Ferrante, MD, Female Pelvic Medicine and Reconstructive Surgery Attending, NYU Langone Health
ClinicalTrials.gov Identifier: NCT01958073    
Other Study ID Numbers: 130403
First Posted: October 8, 2013    Key Record Dates
Results First Posted: September 21, 2020
Last Update Posted: September 21, 2020
Last Verified: August 2020
Keywords provided by Kimberly Ferrante, MD, NYU Langone Health:
Recurrent Urinary Tract Infection
Postmenopausal
Vaginal Estrogen
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Urologic Diseases
Estradiol
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs