Addressing Preference as a Patient-centered Outcome to Prevent Recurrent Urinary Tract Infection (rUTI) in Post-menopausal Women: a Cross-over Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Vaginally applied estrogen has been shown to decrease the incidence of Recurrent Urinary Tract Infection (rUTI) in post-menopausal women. However, prior studies have shown the compliance rate for topical estrogen cream is low. The vaginal estradiol tablet has been shown to be preferred by patients being treated for genitourinary syndrome of menopause and has improved compliance. There are no studies looking at the preference of post-menopausal women with rUTI for vaginal estradiol tablet as an alternative to vaginal estradiol cream.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• Women age 20-80 who are post-menopausal or have undergone surgical menopause. Post-menopausal defined as amenorrhea for ≥ 1 year, or surgical menopause through bilateral oophorectomy, or menopausal symptoms for ≥ 1 year in women with prior hysterectomy

• New or previous diagnosis of recurrent Urinary Tract Infections (rUTI) (3 or more UTIs in the past year or 2 or more UTIs in the last 6 months) Must have at least one culture documented UTI, the remaining can be documented by urinalysis showing nitrites and leukocyte esterase.

• Not currently taking daily prophylactic antibiotics

• Willing to use vaginal estrogen for prevention of recurrent UTIs

Locations
United States
North Carolina
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Contact Information
Primary
Martina Gabra, MD
mgabra@wakehealth.edu
336-713-4098
Backup
Sachin Vyas, PhD
svyas@wakehealth.edu
336-713-4098
Time Frame
Start Date: 2024-01-12
Estimated Completion Date: 2026-01
Participants
Target number of participants: 24
Treatments
Active_comparator: cream used first and then switch to tablets
participants will start with 3 months of cream and then switch to tablets
Active_comparator: tablets used first and switch to cream
participants will start with 3 months of tablets and switch to cream
Sponsors
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov