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

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

Study Overview

• Status: Completed
• Conditions: Catheter-Related Infections; Recurrent Urinary Tract Infection
• Intervention / Treatment: Dietary supplement: D-mannose

Detailed Description

Study Design Inclusion criteria Patients visit the Urology clinic in Tzu Chi hospital due to long-term catheterization monthly and diagnosed as recurrent UTI last year. Exclusion criteria 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. Withdraw criteria and rescue medication Severe allergy or side effects occur, or the patient does not want to continue taking medication at any time. Sample Size and Study Duration The estimated patient number: 120. Study duration: 3 years 3. Please specify objectives of study when collecting extra specimen from participants There will be no extra specimen. 4. Expected Endpoints of Treatment Primary outcome: symptomatic UTI episode. Secondary outcome: non-symptomatic UTI, positive urine culture, catheter obstruction, patient report satisfaction

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 231
    • Taipei Tzu Chi Hospital, Taiwan, R.O.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D-mannose followed by Standard Care; 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; 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.
Active Comparator: Standard Care followed by D-mannose; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of asymptomatic positive bacterial culture	The number of participants who developed an asymptomatic positive bacterial culture in their urine samples during the study period.	Up to 2 years
Frequency of urinary catheter obstruction	The total number of urinary catheter obstruction events recorded per participant.	Up to 2 years
Patient and caregiver subjective feelings score	Subjective feelings and satisfaction assessed by the Global Response Assessment (GRA). The GRA is a 7-point scale with scores ranging from -3 (markedly worse) to +3 (markedly better). Higher scores indicate greater symptom improvement and better satisfaction.	Up to 2 years

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Investigators: Study Director: Shu-Yu Wu, bachelor, Taichung Tzu Chi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Catheter; D-mannose
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections; Catheter-Related Infections; Carbohydrates; Sugars; Hexoses; Monosaccharides; Mannose
• Other Study ID Numbers: 10-XD-162

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No