Urinary Tract InfectionsPhase 4PUTIMNCT03497598
Preventing Recurrent Urinary Tract Infections With α-D-mannose
A Phase 4 study testing Mannose and Lactose in people with Urinary Tract Infections, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Mannose and Lactose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 May 2018to 31 May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- ≥ 3 UTIs within the last 12 months or ≥ 2 UTIs within the last 6 months;
- Laboratory urine culture: <103 CFUs
- Age > 18 years
Who cannot join
- UTIs ≥ 12 within 1 year
- Pregnancy or Lactation
- Immune disease
- Lactose intolerance
- Urinary tract anomaly
- Systemic infection
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Recurrent Urinary Tract Infections With α-D-mannose: a Prospective, Randomized, Double-blinded Placebo-controlled Trial
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.
- Conditions
- Urinary Tract Infections
- Being tested
- Mannose, Lactose
- Keywords
- D-mannose
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannoseDrug
Also called D-Mannose Oral Powder
The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.
LactoseDrug
Also called Lactose powder
The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.
| Study group | Role | What they receive |
|---|---|---|
| mannose | Experimental | 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 Receives: Drug: Mannose |
| placebo | Placebo comparator | 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 Receives: Drug: Lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of UTIs
Frequency of UTIs (defined as ≥103 CFU/ 1mL of clean midstream urine) within the 6 months treatment period with D-mannose.
Measured: 6 months
Secondary outcomes (6)
During UTI: Dysuria
4 categories: no, mild, moderate, severe
Measured: during every UTI in the 6 months period
During UTI: Urgency
4 categories: no, mild, moderate, severe
Measured: during every UTI in the 6 months period
During UTI: Frequency
4 categories: no, mild, moderate, severe
Measured: during every UTI in the 6 months period
During UTI: Flank (side) pain
4 categories: no, mild, moderate, severe
Measured: during every UTI in the 6 months period
During UTI: Cystalgia
4 categories: no, mild, moderate, severe
Measured: during every UTI in the 6 months period
During UTI: Back pain
4 categories: no, mild, moderate, severe
Measured: during every UTI in the 6 months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start9 May 2018
- Primary completion31 May 2020
- Study completion31 May 2020
Why it stopped: not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Ryu, Kantonsspital Aarau
- Investigators
- Gloria Ryu, MD, Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497598
- Sponsor's protocol ID
- PUTIM
- Acronym
- PUTIM
- Status last verified
- Sep 2020
- First submitted
- 5 Apr 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23633128Domenici 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.
PubMed 27424995Phe 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.
PubMed 27813195Cooper 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.
PubMed 36041061
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Recurrent Urinary Tract Infections With α-D-mannose: a Prospective, Randomized, Double-blinded Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03497598
- Acronym / sponsor ID
- PUTIM / PUTIM
- Conditions
- Urinary Tract Infections
- Keywords
- D-mannose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- 9 May 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mannose | Experimental | Drug: Mannose2g 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 |
| placebo | Placebo comparator | Drug: Lactose2g 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women
- ≥ 3 UTIs within the last 12 months or ≥ 2 UTIs within the last 6 months;
- Laboratory urine culture: <103 CFUs
- Age > 18 years
Key exclusion criteria (12 listed)
- UTIs ≥ 12 within 1 year
- Pregnancy or Lactation
- Immune disease
- Lactose intolerance
- Urinary tract anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MannoseAlso: D-Mannose Oral PowderThe powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion. | Drug | mannose |
| LactoseAlso: Lactose powderThe powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion. | Drug | placebo |
Primary outcome
Frequency of UTIs
Time frame: 6 months
Frequency of UTIs (defined as ≥103 CFU/ 1mL of clean midstream urine) within the 6 months treatment period with D-mannose.
6 secondary outcomes
During UTI: Dysuria
Time frame: during every UTI in the 6 months period
During UTI: Urgency
Time frame: during every UTI in the 6 months period
During UTI: Frequency
Time frame: during every UTI in the 6 months period
During UTI: Flank (side) pain
Time frame: during every UTI in the 6 months period
During UTI: Cystalgia
Time frame: during every UTI in the 6 months period
During UTI: Back pain
Time frame: during every UTI in the 6 months period
Results and safety
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Background: PubMed 23633128Kranjcec 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.
- Background: PubMed 27424995Domenici 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.
- Background: PubMed 27813195Phe 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.
- Derived from this study: PubMed 36041061Cooper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria Ryu, MD principal investigator
Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mannose and Lactose in people with Urinary Tract Infections, run by Kantonsspital Aarau at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of UTIs (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03497598, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.