Nutraceutical Efficacy for rUTI

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-22

Study Completion Date

2020-04-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There will be a RCT portion of the study with a treatment arm and a control arm and an additional observational arm of the study.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Participants in the RCT treatment and RCT control arm will not be told the name of the nutraceutical being studied. Participants in the observational arm will be aware of the nutraceutical being studied.

Study Groups

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RCT treatment arm

Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days.

Group Type EXPERIMENTAL

D-Mannose

Intervention Type DRUG

A total of 2 g D-mannose daily

RCT control arm

Participants in this arm will not use any additional intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Observational arm

Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm.

Group Type EXPERIMENTAL

D-Mannose

Intervention Type DRUG

A total of 2 g D-mannose daily

Interventions

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D-Mannose

A total of 2 g D-mannose daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

a. Postmenopausal women with recurrent UTI

i. Recurrent UTI defined as:

1. ≥ 2 symptomatic, culture-proven UTI in 6 months OR
2. ≥ 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

Exclusion Criteria

1. Not postmenopausal
3. Complicated UTIs (known renal tract anomaly, inability to empty bladder due to neurologic causes, performs self-catheterization or has an indwelling catheter)
4. Patients with incomplete bladder emptying (defined as post void residual \> 150 cc when minimal voided volume is \>150 cc)
5. 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)
6. History of interstitial cystitis/painful bladder syndrome
7. Urothelial cancer
8. Non-English speaking
9. Enrolled in other clinical trials for UTIs
10. Currently using D-mannose or Methenamine for UTI prevention

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No