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Preventing Recurrent Urinary Tract Infections With α-D-mannose (PUTIM)

Primary Purpose

Urinary Tract Infections

Status
Terminated
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Mannose
Lactose
Sponsored by
Kantonsspital Aarau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infections focused on measuring D-mannose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women
  • ≥ 3 UTIs within the last 12 months or ≥ 2 UTIs within the last 6 months;
  • Laboratory urine culture: <103 CFUs
  • Age > 18 years

Exclusion Criteria:

  • UTIs ≥ 12 within 1 year
  • Pregnancy or Lactation
  • Immune disease
  • Lactose intolerance
  • Urinary tract anomaly
  • Systemic infection
  • Newly started hormone therapy within the last 6 months
  • Antibiotic prophylaxis within the last 6 months
  • α-D-mannose intake within the last month
  • Use of catheters
  • Diabetes mellitus
  • Participation to other studies

Sites / Locations

  • Kantonsspital Aarau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

mannose

placebo

Arm Description

2g d-mannose (white) powder (Hänseler AG, Herisau, Switzerland) daily (sachet) for 6 months.The powder is dispensed in neutral sticks and ready to be dissolved in 100ml of water for oral Ingestion. rUTI diary

2g Hänseler lactose (white) powder (Hänseler AG, Herisau, Switzerland) daily (sachet) for 6 months. The powder is dispensed in neutral sticks and ready to be dissolved in 100ml of water for oral Ingestion. rUTI diary

Outcomes

Primary Outcome Measures

Frequency of UTIs
Frequency of UTIs (defined as ≥103 CFU/ 1mL of clean midstream urine) within the 6 months treatment period with D-mannose.

Secondary Outcome Measures

During UTI: Dysuria
4 categories: no, mild, moderate, severe
During UTI: Urgency
4 categories: no, mild, moderate, severe
During UTI: Frequency
4 categories: no, mild, moderate, severe
During UTI: Flank (side) pain
4 categories: no, mild, moderate, severe
During UTI: Cystalgia
4 categories: no, mild, moderate, severe
During UTI: Back pain
4 categories: no, mild, moderate, severe

Full Information

First Posted
April 5, 2018
Last Updated
September 1, 2020
Sponsor
Kantonsspital Aarau
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1. Study Identification

Unique Protocol Identification Number
NCT03497598
Brief Title
Preventing Recurrent Urinary Tract Infections With α-D-mannose
Acronym
PUTIM
Official Title
Preventing Recurrent Urinary Tract Infections With α-D-mannose: a Prospective, Randomized, Double-blinded Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
not enough patients
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Aarau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this trial, women with history of recurrent urinary tract infections (UTIs) will be followed over the course of 6 months. The women will be randomized either to D- Mannose or Placebo. The primary objective of this study is to investigate if treatment with D-mannose reduces the risk for a UTI recurrence compared to treatment with Placebo. H0: Women with history of recurrent UTIs treated with D-Mannose on average have the same number of recurrent UTIs over the course of 6 months compared to women treated with Placebo. H1: Women with history of recurrent UTIs treated with D-Mannose on average have fewer recurrent UTIs over the course of 6 months compared to women treated with Placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
D-mannose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mannose
Arm Type
Experimental
Arm Description
2g d-mannose (white) powder (Hänseler AG, Herisau, Switzerland) daily (sachet) for 6 months.The powder is dispensed in neutral sticks and ready to be dissolved in 100ml of water for oral Ingestion. rUTI diary
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
2g Hänseler lactose (white) powder (Hänseler AG, Herisau, Switzerland) daily (sachet) for 6 months. The powder is dispensed in neutral sticks and ready to be dissolved in 100ml of water for oral Ingestion. rUTI diary
Intervention Type
Drug
Intervention Name(s)
Mannose
Other Intervention Name(s)
D-Mannose Oral Powder
Intervention Description
The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.
Intervention Type
Drug
Intervention Name(s)
Lactose
Other Intervention Name(s)
Lactose powder
Intervention Description
The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.
Primary Outcome Measure Information:
Title
Frequency of UTIs
Description
Frequency of UTIs (defined as ≥103 CFU/ 1mL of clean midstream urine) within the 6 months treatment period with D-mannose.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
During UTI: Dysuria
Description
4 categories: no, mild, moderate, severe
Time Frame
during every UTI in the 6 months period
Title
During UTI: Urgency
Description
4 categories: no, mild, moderate, severe
Time Frame
during every UTI in the 6 months period
Title
During UTI: Frequency
Description
4 categories: no, mild, moderate, severe
Time Frame
during every UTI in the 6 months period
Title
During UTI: Flank (side) pain
Description
4 categories: no, mild, moderate, severe
Time Frame
during every UTI in the 6 months period
Title
During UTI: Cystalgia
Description
4 categories: no, mild, moderate, severe
Time Frame
during every UTI in the 6 months period
Title
During UTI: Back pain
Description
4 categories: no, mild, moderate, severe
Time Frame
during every UTI in the 6 months period
Other Pre-specified Outcome Measures:
Title
Presence/absence of E. coli, Enterococcus faecali, Klebsiella pneumoniae, Streptococcus agalactiae, Proteus mirabilis, Citro-bacter freundii, Pseudomonas aeruginosa, others not specified
Description
2 categories: yes, no
Time Frame
at the screening and during every UTI in the 6 months period
Title
Weight
Description
in kilograms
Time Frame
at the screening
Title
Height
Description
in cm
Time Frame
at the screening
Title
Menopause status
Description
3 categories: premenopausal, perimenopausal, postmenopausal
Time Frame
at the screening
Title
Sexual activity
Description
2 categories: yes, no
Time Frame
at the screening
Title
Medication
Description
2 categories: yes, no if yes: Name of the medication, dosage, reason for medication, start and end date of medication
Time Frame
at the screening and during every UTI in the 6 months period
Title
Age
Description
in years
Time Frame
at the screening
Title
Birth control
Description
2 categories: yes, no
Time Frame
at the screening
Title
Number of CFU
Description
number
Time Frame
at the screening and during every UTI in the 6 months period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women ≥ 3 UTIs within the last 12 months or ≥ 2 UTIs within the last 6 months; Laboratory urine culture: <103 CFUs Age > 18 years Exclusion Criteria: UTIs ≥ 12 within 1 year Pregnancy or Lactation Immune disease Lactose intolerance Urinary tract anomaly Systemic infection Newly started hormone therapy within the last 6 months Antibiotic prophylaxis within the last 6 months α-D-mannose intake within the last month Use of catheters Diabetes mellitus Participation to other studies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria Ryu, MD
Organizational Affiliation
Kantonsspital Aarau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23633128
Citation
Kranjcec B, Papes D, Altarac S. D-mannose powder for prophylaxis of recurrent urinary tract infections in women: a randomized clinical trial. World J Urol. 2014 Feb;32(1):79-84. doi: 10.1007/s00345-013-1091-6. Epub 2013 Apr 30.
Results Reference
background
PubMed Identifier
27424995
Citation
Domenici L, Monti M, Bracchi C, Giorgini M, Colagiovanni V, Muzii L, Benedetti Panici P. D-mannose: a promising support for acute urinary tract infections in women. A pilot study. Eur Rev Med Pharmacol Sci. 2016 Jul;20(13):2920-5.
Results Reference
background
PubMed Identifier
27813195
Citation
Phe V, Pakzad M, Haslam C, Gonzales G, Curtis C, Porter B, Chataway J, Panicker JN. Open label feasibility study evaluating D-mannose combined with home-based monitoring of suspected urinary tract infections in patients with multiple sclerosis. Neurourol Urodyn. 2017 Sep;36(7):1770-1775. doi: 10.1002/nau.23173. Epub 2016 Nov 4.
Results Reference
background
PubMed Identifier
36041061
Citation
Cooper 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.
Results Reference
derived

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Preventing Recurrent Urinary Tract Infections With α-D-mannose

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