Ignite Creation Date:
2024-05-06 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03395288
Status:
TERMINATED
Last Update Posted:
2022-02-04
First Post:
2017-12-28
Brief Title:
Nutraceutical Efficacy for rUTI
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Randomized Controlled Trial to Determine the Efficacy of Nutraceutical vs Control as Non-antibiotic Prophylaxis for Recurrent Urinary Tract Infection in Postmenopausal Women Using Vaginal Estrogen Therapy
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Performed a futility analysis and determined that study objectives could not be met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study designed to evaluate the efficacy of a nutraceutical as a non-antibiotic treatment to prevent recurrent urinary tract infections in women that have completed menopause and are on vaginal estrogen therapy An additional group of women with recurrent urinary tract infections that have completed menopause but are not using vaginal estrogen therapy will be followed while taking the nutraceutical The study length is ninety days from the date that the study participant will be instructed is day 1
Detailed Description:
The objective of this study is to determine the efficacy of a nutraceutical as a non-antibiotic prophylaxis for postmenopausal women on vaginal estrogen therapy VET with a history of symptomatic culture-proven recurrent urinary tract infection rUTI by means of a randomized controlled trial Recurrent urinary tract infections have a significant impact on patient health quality of life and finances personal and societal
The most common uropathogen for both acute and recurrent UTIs is Escherichia coli
Historically patients with rUTI have been placed on long-term prophylactic antibiotics to prevent recurrence Long term antibiotic use can lead to antibiotic resistance collateral damage to normal flora and organ damage such as pulmonary and hepatic toxicity with long-term nitrofurantoin use There is an increasing prevalence of antibiotic resistance of uropathogenic E coli and other uropathogens Antibiotic resistance and its consequences have resulted in a need for non-antibiotic prophylaxis regimens
A growing body of literature supports the use of vaginal estrogen therapy as a first-line non-antibiotic UTI prevention strategy in postmenopausal women While VET has been shown to significantly reduce the risk of rUTIs some women continue to have rUTIs Other non-antibiotic strategies have been utilized including D-mannose a nutraceutical Three prior studies examined D-mannose as an isolated therapy with promising results but in our experience a multimodal approach has often been needed Therefore additional studies such as this proposed research are needed to determine the potential additive effect of a nutraceutical as a non-antibiotic prophylaxis for postmenopausal women using vaginal estrogen therapy
The most common uropathogen for both acute and recurrent UTIs is Escherichia coli
Historically patients with rUTI have been placed on long-term prophylactic antibiotics to prevent recurrence Long term antibiotic use can lead to antibiotic resistance collateral damage to normal flora and organ damage such as pulmonary and hepatic toxicity with long-term nitrofurantoin use There is an increasing prevalence of antibiotic resistance of uropathogenic E coli and other uropathogens Antibiotic resistance and its consequences have resulted in a need for non-antibiotic prophylaxis regimens
A growing body of literature supports the use of vaginal estrogen therapy as a first-line non-antibiotic UTI prevention strategy in postmenopausal women While VET has been shown to significantly reduce the risk of rUTIs some women continue to have rUTIs Other non-antibiotic strategies have been utilized including D-mannose a nutraceutical Three prior studies examined D-mannose as an isolated therapy with promising results but in our experience a multimodal approach has often been needed Therefore additional studies such as this proposed research are needed to determine the potential additive effect of a nutraceutical as a non-antibiotic prophylaxis for postmenopausal women using vaginal estrogen therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None