Phase 3 N=60 Randomized Treatment

D Mannose in Recurrent Urinary Tract Infections

Recurrent Urinary Tract Infection

Bottom Line

View on ClinicalTrials.gov: NCT01808755 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Days — 200; 52.7 days

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: D Mannose (Dietary_supplement); trimethoprim/sulfamethoxazole (Drug)
Age: Adult, Older Adult · 22+ yrs
Sex: Female
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Days	200; 52.7	—

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).

Eligibility Criteria

Inclusion Criteria

Patients 18 years old or older
3 or more culture documented urinary tract infections in the preceding 12 months
Patients who had not taken antimicrobials within 4 weeks and were not pregnant or contemplating pregnancy.

Exclusion Criteria

Patients with evidence of upper urinary tract infection, such as temperature higher than 38 °C, flank/lumbar pain or tenderness.

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Data sourced from ClinicalTrials.gov (NCT01808755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.