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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mannose | Drug | The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of UTIs | Frequency of UTIs (defined as ≥103 CFU/ 1mL of clean midstream urine) within the 6 months treatment period with D-mannose. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| During UTI: Dysuria | 4 categories: no, mild, moderate, severe | during every UTI in the 6 months period |
| During UTI: Urgency | 4 categories: no, mild, moderate, severe |
| Measure | Description | Time Frame |
|---|---|---|
| Presence/absence of E. coli, Enterococcus faecali, Klebsiella pneumoniae, Streptococcus agalactiae, Proteus mirabilis, Citro-bacter freundii, Pseudomonas aeruginosa, others not specified | 2 categories: yes, no | at the screening and during every UTI in the 6 months period |
| Weight |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gloria Ryu, MD | Kantonsspital Aarau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau | Aarau | 5001 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23633128 | Background | 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. | |
| 27424995 | Background | 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. |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D008358 | Mannose |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D004187 |
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| Lactose | Drug | The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion. |
|
|
| during every UTI in the 6 months period |
| During UTI: Frequency | 4 categories: no, mild, moderate, severe | during every UTI in the 6 months period |
| During UTI: Flank (side) pain | 4 categories: no, mild, moderate, severe | during every UTI in the 6 months period |
| During UTI: Cystalgia | 4 categories: no, mild, moderate, severe | during every UTI in the 6 months period |
| During UTI: Back pain | 4 categories: no, mild, moderate, severe | during every UTI in the 6 months period |
in kilograms |
| at the screening |
| Height | in cm | at the screening |
| Menopause status | 3 categories: premenopausal, perimenopausal, postmenopausal | at the screening |
| Sexual activity | 2 categories: yes, no | at the screening |
| Medication | 2 categories: yes, no if yes: Name of the medication, dosage, reason for medication, start and end date of medication | at the screening and during every UTI in the 6 months period |
| Age | in years | at the screening |
| Birth control | 2 categories: yes, no | at the screening |
| Number of CFU | number | at the screening and during every UTI in the 6 months period |
| 27813195 | Background | 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. |
| 36041061 | Derived | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |