Ignite Creation Date:
2024-05-06 @ 2:01 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01958073
Status:
COMPLETED
Last Update Posted:
2020-09-21
First Post:
2013-03-27
Brief Title:
Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VESPR
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
Detailed Description:
This was an investigator-initiated multicenter single-blind randomized placebo-controlled trial of vaginal estrogen delivered by estradiol ring or conjugated estrogen cream compared to placebo cream This study was conducted by the Divisions of Female Pelvic Medicine and Reconstructive Surgery at three academic institutions
Potential participants were recruited from women receiving care for rUTIs in the clinics of each institution Women were postmenopausal as defined by amenorrhea for 12 months history of bilateral salpingoophrectomy or in patients with prior hysterectomy defined as menopausal symptoms for 1 year or age 55 Participants had documented rUTI three or more in one year or two in six months by positive urine culture Participants were excluded if they had undergone urologic surgery within three months of screening or planned surgery within one year of screening had the diagnosis of painful bladder syndrome history of UTI requiring the use of intravenous antibiotics or one oral antibiotic available for treatment based on allergies and resistance profiles known etiology of infections eg urologic stones fistulas fecal incontinence catheterization or poorly controlled diabetes urothelial cancer or actively treated estrogen sensitive tumor Participant enrollment was deferred in the setting of undiagnosed hematuria or vaginal bleeding but enrollment could occur after negative workup for malignancy Participants deferred enrollment if they used vaginal androgens estrogens or progestins within six months or if they used medications or supplements known to prevent UTI eg cranberry products D mannose prophylactic antibiotics methenamine hippurate within three months of enrollment but could enroll after washout Those with a remote history of estrogen-sensitive tumor required approval by her oncologist or primary care physician
Participants were initially randomized to receive either vaginal estrogen via estradiol ring or conjugated estrogen cream or placebo cream in a 111 fashion and were told that there were placebo and vaginal estrogen arms but were unaware that there was not a placebo ring Participants were randomized to either conjugated estrogen cream at a strength of 0625 mgg dosed at 05g 0312 mg twice a week estradiol ring containing 2mg of estradiol placed vaginally every three months by study personnel or placebo cream which was an over-the-counter lubricant containing mineral oil petrolatum ceresin and paraffin dosed at 05g twice a week If participants in any arm developed three UTI in the six-month treatment period they were unblinded If on placebo they were provided active study drug or if they were in the vaginal estrogen arm they were treated according to the providers clinical practice and their outcomes recorded for the remainder of the study The primary outcome of occurrence of UTI was assessed at six months or the end of study blinding whichever occurred first In order to improve recruitment and assess long-term compliance satisfaction and efficacy we offered open label use of estradiol ring or conjugated estrogen cream after unblinding until month 12 of the study
Clean-catch urine cultures were collected when participants were symptomatic fever 38 degrees C urgency frequency dysuria or suprapubic tenderness Women were asked to have all urine labs done at the parent site as per standard clinical practice The primary outcome of the study was the presence of a UTI in the randomized six months We also assessed rates of UTI over the course of the 12-month study in all participants as-treated Quality of life QOL questionnaires were administered at baseline six months or unblinding and 12 months Questionnaires included the Pelvic Floor Distress Inventory PFDI-20 Pelvic Floor Impact Questionnaire PFIQ-7 Medical Epidemiologic and Social Aspects of Aging Questionnaire MESA Female Sexual Function Index FSFI and Patient Satisfaction Questionnaire PSQ Global Perception of Improvement GPI and Estimated Percent Improvement EPI rating scales Baseline medical history and concomitant pelvic medicine diagnoses were also collected Participants using a cream treatment were asked to keep medication diaries and return tubes for weighing at months three six nine and 12 Adherence was defined as presence of the estrogen ring or tube weights within 20 of expected at follow up visits In addition before unblinding the participants were asked whether they believed they were on active treatment placebo or were unsure
Potential participants were recruited from women receiving care for rUTIs in the clinics of each institution Women were postmenopausal as defined by amenorrhea for 12 months history of bilateral salpingoophrectomy or in patients with prior hysterectomy defined as menopausal symptoms for 1 year or age 55 Participants had documented rUTI three or more in one year or two in six months by positive urine culture Participants were excluded if they had undergone urologic surgery within three months of screening or planned surgery within one year of screening had the diagnosis of painful bladder syndrome history of UTI requiring the use of intravenous antibiotics or one oral antibiotic available for treatment based on allergies and resistance profiles known etiology of infections eg urologic stones fistulas fecal incontinence catheterization or poorly controlled diabetes urothelial cancer or actively treated estrogen sensitive tumor Participant enrollment was deferred in the setting of undiagnosed hematuria or vaginal bleeding but enrollment could occur after negative workup for malignancy Participants deferred enrollment if they used vaginal androgens estrogens or progestins within six months or if they used medications or supplements known to prevent UTI eg cranberry products D mannose prophylactic antibiotics methenamine hippurate within three months of enrollment but could enroll after washout Those with a remote history of estrogen-sensitive tumor required approval by her oncologist or primary care physician
Participants were initially randomized to receive either vaginal estrogen via estradiol ring or conjugated estrogen cream or placebo cream in a 111 fashion and were told that there were placebo and vaginal estrogen arms but were unaware that there was not a placebo ring Participants were randomized to either conjugated estrogen cream at a strength of 0625 mgg dosed at 05g 0312 mg twice a week estradiol ring containing 2mg of estradiol placed vaginally every three months by study personnel or placebo cream which was an over-the-counter lubricant containing mineral oil petrolatum ceresin and paraffin dosed at 05g twice a week If participants in any arm developed three UTI in the six-month treatment period they were unblinded If on placebo they were provided active study drug or if they were in the vaginal estrogen arm they were treated according to the providers clinical practice and their outcomes recorded for the remainder of the study The primary outcome of occurrence of UTI was assessed at six months or the end of study blinding whichever occurred first In order to improve recruitment and assess long-term compliance satisfaction and efficacy we offered open label use of estradiol ring or conjugated estrogen cream after unblinding until month 12 of the study
Clean-catch urine cultures were collected when participants were symptomatic fever 38 degrees C urgency frequency dysuria or suprapubic tenderness Women were asked to have all urine labs done at the parent site as per standard clinical practice The primary outcome of the study was the presence of a UTI in the randomized six months We also assessed rates of UTI over the course of the 12-month study in all participants as-treated Quality of life QOL questionnaires were administered at baseline six months or unblinding and 12 months Questionnaires included the Pelvic Floor Distress Inventory PFDI-20 Pelvic Floor Impact Questionnaire PFIQ-7 Medical Epidemiologic and Social Aspects of Aging Questionnaire MESA Female Sexual Function Index FSFI and Patient Satisfaction Questionnaire PSQ Global Perception of Improvement GPI and Estimated Percent Improvement EPI rating scales Baseline medical history and concomitant pelvic medicine diagnoses were also collected Participants using a cream treatment were asked to keep medication diaries and return tubes for weighing at months three six nine and 12 Adherence was defined as presence of the estrogen ring or tube weights within 20 of expected at follow up visits In addition before unblinding the participants were asked whether they believed they were on active treatment placebo or were unsure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None