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Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream

Primary Purpose

Recurrent Urinary Tract Infection

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Estradiol vaginal cream
Estradiol Vaginal Tablet
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent Urinary Tract Infection focused on measuring vaginal estradiol cream, vaginal estradiol tablet

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Interstitial cystitis or bladder pain syndrome, nephrolithiasis, genitourinary abnormalities, fistula, history of renal transplant or anatomic abnormality of the kidney Fecal incontinence, intermittent catheterization or indwelling catheter, poorly controlled DM, urothelial cancer, estrogen-sensitive cancer including active breast cancer Recent urologic surgery within 3 months Inability to retain vaginal tablet (ex due to advanced prolapse, history of colpocleisis) Other medical reasons that are deemed incompatible with vaginal estrogen treatment Use of vaginal estrogen in the past 1 month- patients can be recruited after a 1 month wash-out period Inability to follow up at clinic study site to give sample, for example due to transportation issues Organ transplant patients Patients on systemic hormone replacement therapy (HRT)

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

cream used first and then switch to tablets

tablets used first and switch to cream

Arm Description

participants will start with 3 months of cream and then switch to tablets

participants will start with 3 months of tablets and switch to cream

Outcomes

Primary Outcome Measures

Patient preference rate for vaginal estradiol cream versus tablet
Preference will be assess at 6 months or at the time of withdrawal, by asking participants: "Which route of vaginal estrogen do you prefer: Vaginal estradiol tablet or vaginal estradiol cream?"

Secondary Outcome Measures

Change in vaginal and urinary microbiome Lactobacillus amount with the use of vaginal estradiol tablet versus cream
Vaginal culture swab and urine culture specimens will be collected - The specimens will be sent for species-specific polymerase chain reaction (PCR) for Lactobacillus
Change in overall satisfaction, convenience, side effects, and effectiveness of vaginal estradiol cream vs tablet using Treatment Satisfaction Questionnaire for Medication (TSQM)
Treatment Satisfaction Questionnaire for Medication (TSQM) - The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. A questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration.
Changes in adherence scores
Adherence will be assessed by the medication adherence questionnaire (MAQ) - The MAQ will be used to determine medication adherence. This questionnaire asks respondents about past experience in taking medications. The responses are 'yes' or 'no' and are scored as yes=1 and no=0. Scores will be summed: high adherence = score of 0 points; medium adherence = score of 1-2 points, and low adherence = score of 3-4 points. Means and standard deviations will be compared within and between groups.

Full Information

First Posted
February 1, 2023
Last Updated
September 26, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05723601
Brief Title
Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream
Official Title
Addressing Preference as a Patient-centered Outcome to Prevent Recurrent Urinary Tract Infection (rUTI) in Post-menopausal Women: a Cross-over Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
This study is a cross-over randomized study to assess preference. Participants will be in the study for 6 months, they will use vaginal estradiol cream for 3 months and vaginal estradiol tablet for 3 months. Patients who meet diagnostic criteria for rUTI will be recruited. Group A participants will start with 3 months of cream and then switch to tablets. Group B will start with 3 months of tablets and switch to cream. In addition, participants may be started on other supplemental medications (Cranberry, D-mannose, methenamine) at the discretion of their provider. Patients will get monthly phone calls to assess for side effects, safety concerns, and symptoms of UTI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection
Keywords
vaginal estradiol cream, vaginal estradiol tablet

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cream used first and then switch to tablets
Arm Type
Active Comparator
Arm Description
participants will start with 3 months of cream and then switch to tablets
Arm Title
tablets used first and switch to cream
Arm Type
Active Comparator
Arm Description
participants will start with 3 months of tablets and switch to cream
Intervention Type
Drug
Intervention Name(s)
Estradiol vaginal cream
Intervention Description
Participants will use vaginal estradiol cream for 3 months
Intervention Type
Drug
Intervention Name(s)
Estradiol Vaginal Tablet
Intervention Description
Participants will use vaginal estradiol tablet for 3 months
Primary Outcome Measure Information:
Title
Patient preference rate for vaginal estradiol cream versus tablet
Description
Preference will be assess at 6 months or at the time of withdrawal, by asking participants: "Which route of vaginal estrogen do you prefer: Vaginal estradiol tablet or vaginal estradiol cream?"
Time Frame
month 6
Secondary Outcome Measure Information:
Title
Change in vaginal and urinary microbiome Lactobacillus amount with the use of vaginal estradiol tablet versus cream
Description
Vaginal culture swab and urine culture specimens will be collected - The specimens will be sent for species-specific polymerase chain reaction (PCR) for Lactobacillus
Time Frame
Baseline, Month 3, and Month 6
Title
Change in overall satisfaction, convenience, side effects, and effectiveness of vaginal estradiol cream vs tablet using Treatment Satisfaction Questionnaire for Medication (TSQM)
Description
Treatment Satisfaction Questionnaire for Medication (TSQM) - The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. A questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration.
Time Frame
Month 3 and Month 6
Title
Changes in adherence scores
Description
Adherence will be assessed by the medication adherence questionnaire (MAQ) - The MAQ will be used to determine medication adherence. This questionnaire asks respondents about past experience in taking medications. The responses are 'yes' or 'no' and are scored as yes=1 and no=0. Scores will be summed: high adherence = score of 0 points; medium adherence = score of 1-2 points, and low adherence = score of 3-4 points. Means and standard deviations will be compared within and between groups.
Time Frame
Month 3 and Month 6

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Interstitial cystitis or bladder pain syndrome, nephrolithiasis, genitourinary abnormalities, fistula, history of renal transplant or anatomic abnormality of the kidney Fecal incontinence, intermittent catheterization or indwelling catheter, poorly controlled DM, urothelial cancer, estrogen-sensitive cancer including active breast cancer Recent urologic surgery within 3 months Inability to retain vaginal tablet (ex due to advanced prolapse, history of colpocleisis) Other medical reasons that are deemed incompatible with vaginal estrogen treatment Use of vaginal estrogen in the past 1 month- patients can be recruited after a 1 month wash-out period Inability to follow up at clinic study site to give sample, for example due to transportation issues Organ transplant patients Patients on systemic hormone replacement therapy (HRT)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Gabra, MD
Phone
336-713-4098
Email
mgabra@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin Vyas, PhD
Phone
336-713-4098
Email
svyas@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candace Parker-Autry, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Gabra, MD
Phone
336-713-4098
Email
mgabra@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Sachin Vyas, PhD
Phone
336-713-4098
Email
svyas@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data will be shared with other researchers
Citations:
Citation
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Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream

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