Recurrent Urinary Tract InfectionNCT07637903
Treatment and Prevention of Catheter Related Urinary Tract Infection Use D-mannose
A study testing D-mannose in people with Recurrent Urinary Tract Infection and Catheter-Related Infections, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
Purpose of study To find out whether D-mannose use can prevent urinary tract infection in patients need long-term catheterization. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Recurrent Urinary Tract Infection, Catheter-Related Infections
- What is being tested?
- D-mannose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 May 2022to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients visit the Urology clinic in Tzu Chi hospital due to long-term catheterization monthly and diagnosed as recurrent UTI last year.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of study To find out whether D-mannose use can prevent urinary tract infection in patients need long-term catheterization.
Read the 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
- Being tested
- D-mannose
- Keywords
- D-mannose, Catheter
- Medical subject headings
- Urinary Tract Infections, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-mannoseDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: D-mannose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of symptomatic UTIs requiring treatment
The total number of symptomatic urinary tract infections (UTIs) that required medical treatment during the study period.
Measured: Up to 2 years
Secondary outcomes (3)
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.
Measured: Up to 2 years
Frequency of urinary catheter obstruction
The total number of urinary catheter obstruction events recorded per participant.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start4 May 2022
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Yu Wu, bachelor, Study director, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637903
- Sponsor's protocol ID
- 10-XD-162
- Status last verified
- Jun 2026
- First submitted
- 4 May 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Prevention of Catheter Related Urinary Tract Infection Use D-mannose
- ClinicalTrials.gov ID
- NCT07637903
- Acronym / sponsor ID
- 10-XD-162
- Keywords
- D-mannose, Catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of study To find out whether D-mannose use can prevent urinary tract infection in patients need long-term catheterization.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| D-mannose followed by Standard Care | Experimental | Dietary Supplement: D-mannoseParticipants 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. |
| Standard Care followed by D-mannose | Active comparator | Dietary Supplement: D-mannoseParticipants 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. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients visit the Urology clinic in Tzu Chi hospital due to long-term catheterization monthly and diagnosed as recurrent UTI last year.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-mannoseGive 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. | Dietary supplement | D-mannose followed by Standard Care, Standard Care followed by D-mannose |
Primary outcome
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.
3 secondary outcomes
Incidence of asymptomatic positive bacterial culture
Time frame: Up to 2 years
Frequency of urinary catheter obstruction
Time frame: Up to 2 years
Patient and caregiver subjective feelings score
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Yu Wu, bachelor study director
Taichung Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-mannose in people with Recurrent Urinary Tract Infection and Catheter-Related Infections, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of symptomatic UTIs requiring treatment (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.