PUTIM: Preventing Recurrent Urinary Tract Infections With α-D-mannose

• Sponsor: Kantonsspital Aarau (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03497598
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.7
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections	Drug: Mannose; Drug: Lactose	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Preventing Recurrent Urinary Tract Infections With α-D-mannose: a Prospective, Randomized, Double-blinded Placebo-controlled Trial
• Actual Study Start Date: May 9, 2018
• Actual Primary Completion Date: May 31, 2020
• Actual Study Completion Date: May 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mannose 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	Drug: Mannose; The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.; Other Names: D-Mannose Oral Powder
Placebo Comparator: placebo 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	Drug: Lactose; The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.; Other Names: Lactose powder

Outcome Measures

Primary Outcome Measures

1. Frequency of UTIs [6 months]

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

Secondary Outcome Measures

1. During UTI: Dysuria [during every UTI in the 6 months period]

   4 categories: no, mild, moderate, severe

2. During UTI: Urgency [during every UTI in the 6 months period]

   4 categories: no, mild, moderate, severe

3. During UTI: Frequency [during every UTI in the 6 months period]

   4 categories: no, mild, moderate, severe

4. During UTI: Flank (side) pain [during every UTI in the 6 months period]

   4 categories: no, mild, moderate, severe

5. During UTI: Cystalgia [during every UTI in the 6 months period]

   4 categories: no, mild, moderate, severe

6. During UTI: Back pain [during every UTI in the 6 months period]

   4 categories: no, mild, moderate, severe

Other Outcome Measures

1. Presence/absence of E. coli, Enterococcus faecali, Klebsiella pneumoniae, Streptococcus agalactiae, Proteus mirabilis, Citro-bacter freundii, Pseudomonas aeruginosa, others not specified [at the screening and during every UTI in the 6 months period]

   2 categories: yes, no

2. Weight [at the screening]

   in kilograms

3. Height [at the screening]

   in cm

4. Menopause status [at the screening]

   3 categories: premenopausal, perimenopausal, postmenopausal

5. Sexual activity [at the screening]

   2 categories: yes, no

6. Medication [at the screening and during every UTI in the 6 months period]

   2 categories: yes, no if yes: Name of the medication, dosage, reason for medication, start and end date of medication

7. Age [at the screening]

   in years

8. Birth control [at the screening]

   2 categories: yes, no

9. Number of CFU [at the screening and during every UTI in the 6 months period]

   number

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kantonsspital Aarau	Aarau		Switzerland	5001

Sponsors and Collaborators

• Kantonsspital Aarau

Investigators

• Principal Investigator: Gloria Ryu, MD, Kantonsspital Aarau

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Kranjčec B, Papeš 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.
• Phé 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.

• Responsible Party: Gloria Ryu, Assistant medical director, Kantonsspital Aarau
• ClinicalTrials.gov Identifier: NCT03497598
• Other Study ID Numbers: PUTIM
• First Posted: Apr 13, 2018
• Last Update Posted: Sep 2, 2020
• Last Verified: Sep 1, 2020

• 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
• Keywords provided by Gloria Ryu, Assistant medical director, Kantonsspital Aarau: D-mannose
• Additional relevant MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections

Study Results

No Results Posted as of Sep 2, 2020