D Mannose in Recurrent Urinary Tract Infections
Recurrent Urinary Tract Infections in Adult Women: a Pilot Study With Oral D Mannose
1 other identifier
interventional
60
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 7, 2013
CompletedFirst Posted
Study publicly available on registry
March 11, 2013
CompletedResults Posted
Study results publicly available
May 21, 2014
CompletedMay 21, 2014
April 1, 2014
9 months
March 7, 2013
April 1, 2013
April 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Days
time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture
168
Study Arms (2)
D Mannose
EXPERIMENTAL1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks
trimethoprim/sulfamethoxazole
ACTIVE COMPARATORintervention 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
Interventions
1 gr. every 8 hours
one cp b.i.d. for 5 days. Then one week of antibiotic every 4 weeks for the following 23 weeks
Eligibility Criteria
You may qualify if:
- Patients 18 years old or older
- 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.
You may not qualify if:
- Patients with evidence of upper urinary tract infection, such as temperature higher than 38 °C, flank/lumbar pain or tenderness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urology Department Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Related Publications (4)
Mulvey MA, Lopez-Boado YS, Wilson CL, Roth R, Parks WC, Heuser J, Hultgren SJ. Induction and evasion of host defenses by type 1-piliated uropathogenic Escherichia coli. Science. 1998 Nov 20;282(5393):1494-7. doi: 10.1126/science.282.5393.1494.
PMID: 9822381BACKGROUNDMulvey MA, Schilling JD, Hultgren SJ. Establishment of a persistent Escherichia coli reservoir during the acute phase of a bladder infection. Infect Immun. 2001 Jul;69(7):4572-9. doi: 10.1128/IAI.69.7.4572-4579.2001.
PMID: 11402001BACKGROUNDMulvey MA, Schilling JD, Martinez JJ, Hultgren SJ. Bad bugs and beleaguered bladders: interplay between uropathogenic Escherichia coli and innate host defenses. Proc Natl Acad Sci U S A. 2000 Aug 1;97(16):8829-35. doi: 10.1073/pnas.97.16.8829.
PMID: 10922042BACKGROUNDCooper TE, Teng C, Howell M, Teixeira-Pinto A, Jaure A, Wong G. D-mannose for preventing and treating urinary tract infections. Cochrane Database Syst Rev. 2022 Aug 30;8(8):CD013608. doi: 10.1002/14651858.CD013608.pub2.
PMID: 36041061DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- D. Porru
- Organization
- Divisione Urologia IRCCS Policlinico San Matteo Pavia, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Daniele Porru, MD
Urology Dept. Fondazione IRCCS Policlinico San Matteo Pavia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Urologist, Principal investigator
Study Record Dates
First Submitted
March 7, 2013
First Posted
March 11, 2013
Study Start
January 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
May 21, 2014
Results First Posted
May 21, 2014
Record last verified: 2014-04