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Completed

NCT Number: NCT07637903

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.

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Key information

Conditions

Recurrent Urinary Tract Infection Catheter-Related Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

New Taipei City, 231, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of symptomatic UTIs requiring treatment

    Time frame: Up to 2 years

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

Secondary outcomes

  1. Incidence of asymptomatic positive bacterial culture

    Time frame: Up to 2 years

    The number of participants who developed an asymptomatic positive bacterial culture in their urine samples during the study period.

  2. Frequency of urinary catheter obstruction

    Time frame: Up to 2 years

    The total number of urinary catheter obstruction events recorded per participant.

  3. Patient and caregiver subjective feelings score

    Time frame: Up to 2 years

    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.

Sponsors and collaborators

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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