Treatment and Prevention of Catheter Related Urinary Tract Infection Use D-mannose
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
New Taipei City, Taiwan, 231
- Taipei Tzu Chi Hospital, Taiwan, R.O.C.
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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. |
|
Aktiv komparator: 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.
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of symptomatic UTIs requiring treatment
Tidsramme: Up to 2 years
|
The total number of symptomatic urinary tract infections (UTIs) that required medical treatment during the study period.
|
Up to 2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of asymptomatic positive bacterial culture
Tidsramme: Up to 2 years
|
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
Tidsramme: Up to 2 years
|
The total number of urinary catheter obstruction events recorded per participant.
|
Up to 2 years
|
|
Patient and caregiver subjective feelings score
Tidsramme: 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.
|
Up to 2 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Shu-Yu Wu, bachelor, Taichung Tzu Chi Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10-XD-162
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .