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D Mannose in Recurrent Urinary Tract Infections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01808755
First Posted: March 11, 2013
Last Update Posted: May 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniele Porru, IRCCS Policlinico S. Matteo
  Purpose

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).


Condition Intervention Phase
Recurrent Urinary Tract Infection Dietary Supplement: D Mannose Drug: trimethoprim/sulfamethoxazole Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recurrent Urinary Tract Infections in Adult Women: a Pilot Study With Oral D Mannose

Resource links provided by NLM:


Further study details as provided by Daniele Porru, IRCCS Policlinico S. Matteo:

Primary Outcome Measures:
  • Days [ Time Frame: 168 ]
    time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture


Enrollment: 60
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D Mannose
1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks
Dietary Supplement: D Mannose
1 gr. every 8 hours
Other Name: sugar
Drug: trimethoprim/sulfamethoxazole
one cp b.i.d. for 5 days. Then one week of antibiotic every 4 weeks for the following 23 weeks
Other Name: trimethoprim/sulfamethoxazole 160 mg/800 mg
Active Comparator: trimethoprim/sulfamethoxazole
intervention was a 5-days course of trimethoprim/sulfamethoxazole cp 160 mg/800 mg twice a day. Then one week of antibiotic every 4 weeks for the following 23 weeks
Dietary Supplement: D Mannose
1 gr. every 8 hours
Other Name: sugar
Drug: trimethoprim/sulfamethoxazole
one cp b.i.d. for 5 days. Then one week of antibiotic every 4 weeks for the following 23 weeks
Other Name: trimethoprim/sulfamethoxazole 160 mg/800 mg

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808755


Locations
Italy
Urology Department Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Investigators
Principal Investigator: Daniele Porru, MD Urology Dept. Fondazione IRCCS Policlinico San Matteo Pavia
  More Information

Additional Information:
Publications:
Responsible Party: Daniele Porru, Consultant Urologist, Principal investigator, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT01808755     History of Changes
Other Study ID Numbers: DMannose UTIs
First Submitted: March 7, 2013
First Posted: March 11, 2013
Results First Submitted: April 1, 2013
Results First Posted: May 21, 2014
Last Update Posted: May 21, 2014
Last Verified: April 2014

Keywords provided by Daniele Porru, IRCCS Policlinico S. Matteo:
recurrent urinary tract infections
D Mannose
cystitis
antibiotic treatment

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Trimethoprim
Sulfamethoxazole
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors