CompletedPhase 3

D Mannose in Recurrent Urinary Tract Infections

Italy60 participantsStarted 2012-01

Plain-language 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).

Who can participate

Age range

22 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Days

Timeframe: 168

Trial details

NCT IDNCT01808755

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-10

Results submitted2013-04-01

View on ClinicalTrials.gov More Recurrent Urinary Tract Infection trials