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D Mannose in Recurrent Urinary Tract Infections

NCT01808755 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-05-21

Study results available
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Summary

Background- In recurrent urinary tract infections (RUTIs) usual prophylactic antibiotic regimes do not change the long term risk of recurrence.

Objective- D-Mannose is a sugar, it sticks to E. coli bacteria, the aim of the study was to evaluate its efficacy in the treatment and prophylaxis of recurrent UTIs.

Design, setting and participants- : In this crossover trial female patient were eligible for the study if they had recurrent UTIs, that is three ore more episodes during the preceding 12 months. Suitable patients were randomly assigned to antibiotic treatment with trimethoprim/sulfamethoxazole or to a regimen of oral D Mannose for 24 weeks, and received the other intervention in the second phase of the study.

Outcome measurements and statistical analysis- The time to recurrence of UTI, bladder pain (VAS p) and urinary urgency (VAS u) were evaluated at the end of antibiotic therapy and at the and of 24 weeks fo D Mannose. The results for quantitative variables were expressed as mean values and SD as they were all normally distributed (Shapiro-Wilk test). T-test for paired data was used to analyze differences of time of recurrence, VAS pain, Vas urgency and number of voidings between treatment. Data analysis was performed with STATA statistical package (release 11,1, 2010, Stata Corporation, College Station, Texas, USA).

Conditions

  • Recurrent Urinary Tract Infection

Interventions

DIETARY_SUPPLEMENT

D Mannose

1 gr. every 8 hours

DRUG

trimethoprim/sulfamethoxazole

one cp b.i.d. for 5 days. Then one week of antibiotic every 4 weeks for the following 23 weeks

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Daniele Porru, MD · Urology Dept. Fondazione IRCCS Policlinico San Matteo Pavia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01808755 on ClinicalTrials.gov