Catheter-Related Infections, Recurrent Urinary Tract Infection
Conditions
Keywords
D-mannose, Catheter
Brief summary
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
Interventions
DIETARY_SUPPLEMENTD-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.
Sponsors
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of symptomatic UTIs requiring treatment | Up to 2 years | The total number of symptomatic urinary tract infections (UTIs) that required medical treatment during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of asymptomatic positive bacterial culture | Up to 2 years | The number of participants who developed an asymptomatic positive bacterial culture in their urine samples during the study period. |
| Frequency of urinary catheter obstruction | Up to 2 years | The total number of urinary catheter obstruction events recorded per participant. |
| Patient and caregiver subjective feelings score | 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. |
Countries
Taiwan
Contacts
STUDY_DIRECTORShu-Yu Wu, bachelor
Taichung Tzu Chi Hospital
Outcome results
None listed