Nutraceutical Efficacy for rUTI

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine

Criteria

Inclusion Criteria:

For the RCT arms of the study, the following inclusion criteria will apply:

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

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:

1. Not postmenopausal

2. 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))

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

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.