Protocol summary

Summary
The aim of this study was to compare the effect of cranberry pills and tablets nitrofurantoin on the prevention of recurrent urinary tract infection recurrence in the form of a clinical trial on 3 groups each one contains twenty one 15-45 years old women with recurrent urinary tract infection that are visited in Kashani hospital’s clinic. The patients that have genitourinary anatomic problems (stone, uretrocell, hydronephros) and genitourinary dysfunction (neurogenic bladder) and bacterial persistence have been removed from this study. Patients were randomly divided into three groups. Before entering the study, the patients were examined clinically in terms of functional and anatomic problems and if necessary ultrasonography were done. After the treatment of current urinary tract infections and clinical improvement, the first group received cranberry 500 mg tablets for 6 months and the second group received Nitrofurantoin 100 mg during night for 6 months and the third group received placebo. These patients were followed up during the six months and once in two months the patient were examined clinically, UA, UC, and in terms of recurrent cystitis, the patients were advised whenever they see the signs of the infection they should go to the hospital .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015111625072N1
Registration date: 2015-12-02, 1394/09/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Narjeskhaton Dadkhah
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0061
Email address
dadgar@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of shahrekord University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cranberry pills and nitrofurantoin tablets on the prevention of relapse recurrent urinary tract infections in women.
Public title
prevention of recurrent urinary tract infections in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women 15-45 years old who suffer from cystitis Kashani hospital clinics were frequent. Exclusion criteria: those with anatomic abnormalities of the genitourinary system (stone,Ureterocele and hydronephrosis)؛ impaired functional genitourinary system (neurogenic bladder) Darshtnd.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University Of Medical Sciences Shahrekord
Street address
Shahrekord University Of Medical Sciences , kashani Street,Shahrekord, Iran
City
shahrekord
Postal code
iran
Approval date
2014-05-25, 1393/03/04
Ethics committee reference number
1155

Health conditions studied

1

Description of health condition studied
Recurrent urinary tract infections
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases

Primary outcomes

1

Description
Recurrent urinary tract infections
Timepoint
Every two months to six months
Method of measurement
Physical examination, clinical signs of cystitis, urine culture and urine analysis Urine

Secondary outcomes

1

Description
Burning and frequent urination
Timepoint
Once every two months to six months
Method of measurement
Ask the patient

Intervention groups

1

Description
group1: cranberry 500 mg tablets for 6 months .
Category
Treatment - Drugs

2

Description
group2: received nitrofurantoin 100 mg during night for 6 months
Category
Treatment - Drugs

3

Description
control group: received placebo for 6 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Doctor Majid Shirani
Street address
Kashani Hospital , Kashani street, Shahrekord
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Doctor Sayedkamal Solati
Street address
Blv University, Kashani Street, Shahrekord University Of Medical Sciences
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Doctor Majid Shirani
Position
Specialist kidney and urinary tract, Educational Assistant
Other areas of specialty/work
Street address
Kashani street, Shahrekord , University Of Medical Sciences
City
Shahrekord
Postal code
Iran
Phone
+98 38 3333 0061
Fax
Email
Dadgar@skums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Doctor Majid Sirani
Position
Specialist kidney and Urinary Tract
Other areas of specialty/work
Street address
University Of Medical Sciences
City
Shahrekord
Postal code
Iran
Phone
+98 38 3333 0061
Fax
Email
Majd_uro@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Doctor Majid Shirani
Position
Specialist kidney and urinary tract, Educational Assistant
Other areas of specialty/work
Street address
University Of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 3333 0061
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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