Nutraceutical Efficacy for rUTI

  • STATUS
    Recruiting
  • End date
    Dec 24, 2021
  • participants needed
    180
  • sponsor
    Washington University School of Medicine
Updated on 24 January 2021
antibiotic therapy
antibiotics
recurrent urinary tract infection

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.

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.

Details
Condition Urinary tract infection, Recurrent Urinary Tract Infection, Recurrent Urinary Tract Infections, Urinary Tract Infections, urinary tract infection (uti), urinary infection, recurrent utis
Treatment D-Mannose
Clinical Study IdentifierNCT03395288
SponsorWashington University School of Medicine
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 20 yrs?
Are you female?
Do you have any of these conditions: Urinary tract infection or Urinary Tract Infections?
Do you have any of these conditions: Urinary Tract Infections or recurrent utis or Urinary tract infection or Recurrent Urinary Tract Infections or Recurrent Urinary Tract Infection or ur...?
For the RCT arms of the study, the following inclusion criteria will apply
Postmenopausal women with recurrent UTI
Recurrent UTI defined as
2 symptomatic, culture-proven UTI in 6 months OR
3 symptomatic, culture-proven UTI in 12 months
ii. Postmenopausal defined as no menses for at least 12 months or surgical
menopause
b. At least one documented prior uropathogen susceptible to D-mannose
c. Using VET for a minimum of four weeks prior to study day 1
Inclusion criteria for the Observational arm of the study are the same with
the exception of item 'c.' above (using VET for a minimum of four weeks) as
participants will not be on vaginal estrogen therapy

Exclusion Criteria

For the RCT arms of the study, the exclusion criteria are as follows
Not postmenopausal
Currently on daily antibiotic UTI prophylaxis (If this is the only exclusion criteria met, a woman could be cleared for inclusion in study/enrollment after a 2 week washout period occurs prior to inclusion in the study (RCT or Observational arm))
Complicated UTIs (known renal tract anomaly, inability to empty bladder due to neurologic causes, performs self-catheterization or has an indwelling catheter)
Patients with incomplete bladder emptying (defined as post void residual > 150 cc when minimal voided volume is >150 cc)
Known contraindication to VET unless approved by patient's oncologist, oncologic surgeon, or primary care physician (History of or current endometrial cancer; History of estrogen sensitive breast cancer without approval of patient, patient's oncologist, oncologic surgeon, or primary care physician to use vaginal estrogen after counseling)
History of interstitial cystitis/painful bladder syndrome
Urothelial cancer
Non-English speaking
Enrolled in other clinical trials for UTIs
Currently using D-mannose or Methenamine for UTI prevention
Exclusion criteria for the Observational arm of the study are the same with
the exception of item 'e.' above (known contraindication to VET) as
participants will not be on vaginal estrogen therapy
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