Treatment and Prevention of Catheter Related Urinary Tract Infection Use D-mannose

NCT07637903 | Completed

• 1 other identifier: 10-XD-162
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of study To find out whether D-mannose use can prevent urinary tract infection in patients need long-term catheterization.

Conditions

Recurrent Urinary Tract Infection; Catheter-Related Infections

Keywords

D-mannose; Catheter

Outcome Measures

Primary Outcomes (1)

• Number of symptomatic UTIs requiring treatment

  The total number of symptomatic urinary tract infections (UTIs) that required medical treatment during the study period.

  Up to 2 years

Secondary Outcomes (3)

• Incidence of asymptomatic positive bacterial culture

  Up to 2 years

• Frequency of urinary catheter obstruction

  Up to 2 years

• Patient and caregiver subjective feelings score

  Up to 2 years

Study Arms (2)

D-mannose followed by Standard Care

EXPERIMENTAL

Participants receive D-mannose (one tablet, twice daily) for the first year. After one year, D-mannose is suspended, and participants receive standard catheter care for the second year. Follow-up and urine specimen collection occur monthly during scheduled outpatient catheter replacements.

Dietary Supplement: D-mannose

Standard Care followed by D-mannose

ACTIVE COMPARATOR

Participants receive standard catheter care for the first year. After one year, participants receive D-mannose (one tablet, twice daily) for the second year. Follow-up and urine specimen collection occur monthly during scheduled outpatient catheter replacements.

Dietary Supplement: D-mannose

Interventions

D-mannose DIETARY_SUPPLEMENT

Give patients D-mannose, twice a day, one tablet each time, for one year; the research area is divided into two groups, The first group took D-mannose for one year. After the one-year period expired, the use of D-mannose was suspended, and the original standard treatment was resumed treatment, and continued follow-up in the outpatient clinic for one year; the second group maintained the standard treatment for one year, and began to take it after the one-year period expired. Use D-mannose for one year; the grouping method is based on the order of admission of patients in each hospital, with odd-numbered cases in the first group and even-numbered cases in the first group and Second groups. Such patients are fixed in the outpatient clinic to change the urinary catheter every month, so the follow-up time is also arranged during the return visit. Urine specimens were collected at the same time as catheter replacement.

D-mannose followed by Standard Care; Standard Care followed by D-mannose

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients visit the Urology clinic in Tzu Chi hospital due to long-term catheterization monthly and diagnosed as recurrent UTI last year.

You may not qualify if:

• The above patients who unwilling to join this study, patients under 18 years old, women with pregnancy or breastfeeding plans, urological interventions in the past 3 months.

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu Chi Hospital, Taiwan, R.O.C.

New Taipei City, 231, Taiwan

Location

MeSH Terms

Conditions

Urinary Tract Infections; Catheter-Related 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

Study Officials

• Shu-Yu Wu, bachelor

  Taichung Tzu Chi Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Give patients D-mannose, twice a day, one tablet each time, for one year; the research area is divided into two groups,The first group took D-mannose for one year. After the one-year period expired, the use of D-mannose was suspended, and the original standard treatment was resumed treatment, and continued follow-up in the outpatient clinic for one year; the second group maintained the standard treatment for one year, and began to take it after the one-year period expired.

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 10, 2026
• Study Start: May 4, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

TW (1)