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Effect of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections.

Primary Purpose

Recurrent Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Nanotechnology Structured water Magnalife
Trimethoprim
Ordinary bottled drinking water
Sponsored by
University of Sulaimani
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent Urinary Tract Infection focused on measuring nanotechnology water, antibiotic prophylaxis, recurrent UTI.

Eligibility Criteria

24 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 2 (two or more than two) UTI in the last 6 months
  • ≥ 3 (three or more than three) UTI in the last 12 months

Exclusion Criteria:

  • immunotherapy
  • radiotherapy
  • malignancy
  • steroids
  • chronic infections
  • chemotherapy
  • immunosuppressive drugs
  • anatomical abnormality of the urinary tract
  • surgical operation the urinary tract

Sites / Locations

  • College of Medicine, University of Sulaimani

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Interventional (Group M)

Control (Group T)

Placebo (Group O)

Arm Description

The group of patients given nanotechnology structured water magnalife

The group of patients given Trimethoprim

The group of patients given ordinary bottled drinking water

Outcomes

Primary Outcome Measures

Recurrent Urinary Tract Infection
Urinalysis by GUE (>10 white blood cells (WBC)/mm3 per high-power field (HPF) Urine culture (urinary pathogen of ≥105 colony-forming units (CFU) per mL)

Secondary Outcome Measures

Time to first recurrent UTI
The time since the beginning of the study until the first recurrent UTI (days)

Full Information

First Posted
March 11, 2020
Last Updated
March 13, 2020
Sponsor
University of Sulaimani
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1. Study Identification

Unique Protocol Identification Number
NCT04306731
Brief Title
Effect of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections.
Official Title
A Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Use of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 20, 2014 (Actual)
Primary Completion Date
April 21, 2017 (Actual)
Study Completion Date
April 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sulaimani

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study investigates nanotechnology structured water magnalife in urology and to test its effects against lower urinary tract infections (UTI) in females.
Detailed Description
This study represents the first time to use nanotechnology structured water magnalife in urology and to test its effects against lower urinary tract infections (UTI) in females. Urinary tract infection (UTI ) is the second most common bacterial infection, affecting women at a much higher frequency than men. There is a higher rate of recurrence of UTI, and a recurrent infection will follow 25-35% of initial UTI episodes within 3-6 months. Intermittent or prolonged low dose antibiotic therapy has been used to treat and prevent recurrent UTI. Emerging of resistance to antimicrobial agents, enormous economic burden, and the side effects of antibiotics have led to the search for an alternative non-antibiotic prophylaxis of recurrent UTI. Nanotechnology structured water is a new type of drinking water that has been prepared using different types of energy fields and electromagnetic fields to produce this structured water, which has new and different characteristics from the ordinary water. In the current study, the efficacy of nanotechnology structured water magnalife was compared with low-dose Trimethoprim and bottled drinking water for the prevention of recurrent UTI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection
Keywords
nanotechnology water, antibiotic prophylaxis, recurrent UTI.

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
437 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional (Group M)
Arm Type
Experimental
Arm Description
The group of patients given nanotechnology structured water magnalife
Arm Title
Control (Group T)
Arm Type
Active Comparator
Arm Description
The group of patients given Trimethoprim
Arm Title
Placebo (Group O)
Arm Type
Placebo Comparator
Arm Description
The group of patients given ordinary bottled drinking water
Intervention Type
Dietary Supplement
Intervention Name(s)
Nanotechnology Structured water Magnalife
Other Intervention Name(s)
Magnalife, 5200250040466
Intervention Description
Nanotechnology Structured water Magnalife is drinking water that has been modified using nanotechnology to change the structuring of water molecules
Intervention Type
Drug
Intervention Name(s)
Trimethoprim
Other Intervention Name(s)
Proloprim
Intervention Description
Antibiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
Ordinary bottled drinking water
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Recurrent Urinary Tract Infection
Description
Urinalysis by GUE (>10 white blood cells (WBC)/mm3 per high-power field (HPF) Urine culture (urinary pathogen of ≥105 colony-forming units (CFU) per mL)
Time Frame
Twelve months
Secondary Outcome Measure Information:
Title
Time to first recurrent UTI
Description
The time since the beginning of the study until the first recurrent UTI (days)
Time Frame
Twelve months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 2 (two or more than two) UTI in the last 6 months ≥ 3 (three or more than three) UTI in the last 12 months Exclusion Criteria: immunotherapy radiotherapy malignancy steroids chronic infections chemotherapy immunosuppressive drugs anatomical abnormality of the urinary tract surgical operation the urinary tract
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali K M.Sami, Ph.D.
Organizational Affiliation
College of Medicine, University of Sulaimani
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Medicine, University of Sulaimani
City
Sulaymaniyah
State/Province
Kurdistan Region
ZIP/Postal Code
00964
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The duration of illness, number of recurrence of UTI, other co-morbid diseases

Learn more about this trial

Effect of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections.

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