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

NCT01958073 | Completed Phase 4 Results DMC

• 1 other identifier: 130403
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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).

Conditions

Recurrent Urinary Tract Infection

Keywords

Recurrent Urinary Tract Infection; Postmenopausal; Vaginal Estrogen

Outcome Measures

Primary Outcomes (1)

• Occurrence of UTI During Randomization

  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.

  6 months of the randomized period

Secondary Outcomes (9)

• Rates of UTI in Both Randomization Period and Within Placebo When Changed to Open Label Estrogen

  Assessed at 6 months for 'a'; assessed over 12 months for 'b'

• Quality of Life Questionnaire: Female Sexual Function Index

  6 months of the randomized period

• Compliance During Randomization

  6 months of the randomized period

• Occurrence of UTI in Those Compliant With Treatment During Randomization

  6 months of the randomized period

• Quality of Life Questionnaire: MESA I

  6 months of the randomized period

Study Arms (3)

Conjugated Estrogen Vaginal Cream

EXPERIMENTAL

Conjugated estrogen vaginal cream 0.5g per vagina 2 times weekly

Drug: Conjugated Estrogen Vaginal Cream

Estradiol Ring

EXPERIMENTAL

Estradiol Ring per vagina every 3 months

Drug: Estradiol Ring

Placebo

PLACEBO COMPARATOR

Per vagina

Drug: Placebo

Interventions

Conjugated Estrogen Vaginal Cream DRUG

Conjugated Estrogen Vaginal Cream

Estradiol Ring DRUG

Estradiol Ring

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Ability to provide informed consent

You may not qualify if:

• Use of any investigational drug or device within thirty days of screening
• Urologic surgery within the past 3 months of screening or plan for surgery within one year of screening
• Diagnosis of Interstitial Cystitis/painful bladder syndrome
• 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
• 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
• Urothelial cancer
• Actively treated estrogen sensitive tumor (breast or endometrial cancer)
• Undiagnosed vaginal bleeding
• Inability to use a vaginal ring (secondary to advanced prolapse or shortened vaginal length)
• Any medical reason the investigator deems incompatible with treatment with vaginal estrogen
• Prolapse requiring pessary use
• Deferral Criteria
• Undiagnosed hematuria - may enroll after malignancy is ruled out
• 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
• History of estrogen sensitive tumor (breast or endometrial cancer) - requires approval by the subject's primary oncologist or primary care physician

Sponsors & Collaborators

• University of California, San Diego: lead
• American Urogynecologic Society: collaborator
• NYU Langone Health: collaborator

Study Sites (2)

University of California, San Diego

La Jolla, California, 92037, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Related Publications (1)

• Ferrante KL, Wasenda EJ, Jung CE, Adams-Piper ER, Lukacz ES. Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):112-117. doi: 10.1097/SPV.0000000000000749.

  PMID: 31232721 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Difficult recruitment requiring several modifications to the study design, single-blind nature of the trial, underpowered for secondary outcomes.

Results Point of Contact

• Title: Dr. Kimberly Ferrante
• Organization: Kaiser Permanente San Diego

klf0409@gmail.com

6199801439

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Female Pelvic Medicine and Reconstructive Surgery Attending

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 21, 2020
• Results First Posted: September 21, 2020

Record last verified: 2020-08

Locations

US (2)