Treatment and Prevention of Catheter Related Urinary Tract Infection Use D-mannose
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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New Taipei City, Taiwan, 231
- Taipei Tzu Chi Hospital, Taiwan, R.O.C.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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. |
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Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of symptomatic UTIs requiring treatment
Lasso di tempo: Up to 2 years
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The total number of symptomatic urinary tract infections (UTIs) that required medical treatment during the study period.
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Up to 2 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of asymptomatic positive bacterial culture
Lasso di tempo: Up to 2 years
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The number of participants who developed an asymptomatic positive bacterial culture in their urine samples during the study period.
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Up to 2 years
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Frequency of urinary catheter obstruction
Lasso di tempo: Up to 2 years
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The total number of urinary catheter obstruction events recorded per participant.
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Up to 2 years
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Patient and caregiver subjective feelings score
Lasso di tempo: Up to 2 years
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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.
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Up to 2 years
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Collaboratori e investigatori
Investigatori
- Direttore dello studio: Shu-Yu Wu, bachelor, Taichung Tzu Chi Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10-XD-162
Informazioni su farmaci e dispositivi, documenti di studio
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