Nutraceutical Efficacy for rUTI

NCT03395288 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 201711120
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Keywords

UTI; recurrent UTI

Outcome Measures

Primary Outcomes (1)

• Incidence of Symptomatic, Culture Proven Urinary Tract Infections

  To compare the cumulative incidence of symptomatic, culture-proven urinary tract infections in postmenopausal women with a history of rUTI on vaginal estrogen therapy randomized to receive prophylactic D-mannose versus women using vaginal estrogen therapy alone (control).

  each participant will be followed for 90 days during study enrollment

Secondary Outcomes (3)

• Incidence of Symptomatic Culture Proved UTI From D-mannose Susceptible Uropathogens

  each participant will be followed for 90 days during study enrollment

• Side Effects

  each participant will be followed for 90 days during study enrollment

• Incidence of Symptomatic, Culture Proven UTI in All Participants Taking D-mannose

  each participant will be followed for 90 days during study enrollment

Study Arms (3)

RCT treatment arm

EXPERIMENTAL

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.

Drug: D-Mannose

RCT control arm

NO INTERVENTION

Participants in this arm will not use any additional intervention.

Observational arm

EXPERIMENTAL

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.

Drug: D-Mannose

Interventions

D-Mannose DRUG

A total of 2 g D-mannose daily

Observational arm; RCT treatment arm

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: This study will involve only adult, postmenopausal women as recurrent UTI predominantly affect this population. Recurrent UTI in men would be considered complicated and would not be addressed with a prophylactic treatment like d-mannose.In addition, men do not go through menopause and do not have a vagina and would thus not be treated with vaginal estrogen therapy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. Postmenopausal women with recurrent UTI
• i. 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

You may not qualify if:

• Not postmenopausal
• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Lenger SM, Chu CM, Ghetti C, Durkin MJ, Jennings Z, Wan F, Sutcliffe S, Lowder JL. d-Mannose for Recurrent Urinary Tract Infection Prevention in Postmenopausal Women Using Vaginal Estrogen: A Randomized Controlled Trial. Urogynecology (Phila). 2023 Mar 1;29(3):367-377. doi: 10.1097/SPV.0000000000001270. Epub 2022 Oct 15.

  PMID: 36808931 DERIVED

• Lenger SM, Chu CM, Ghetti C, Durkin MJ, Jennings Z, Sutcliffe S, Lowder JL. Feasibility and Research Insights From a Randomized Controlled Trial for Recurrent Urinary Tract Infection Prevention in Postmenopausal Women Using Vaginal Estrogen Therapy. Female Pelvic Med Reconstr Surg. 2022 Jun 1;28(6):e163-e170. doi: 10.1097/SPV.0000000000001171.

  PMID: 35421017 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Mannose

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Limitations and Caveats

The primary limitation of this study was the low recruitment and retention encountered. Study retention was lower than expected. A futility analysis was performed at the interim analysis and we found that we do not have power to detect the effect size difference that we originally estimated.

Results Point of Contact

• Title: Jerry Lowder, MD
• Organization: Washington University

lowderj@wustl.edu

314-362-0063

Study Officials

• Jerry Lowder, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 10, 2018
• Study Start: March 22, 2018
• Primary Completion: April 25, 2020
• Study Completion: April 25, 2020
• Last Updated: February 4, 2022
• Results First Posted: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)