Studying the effect of cranberry medicine on preventing dysuria caused by bladder aerodynamics
Design
Clinical trial. With control group with factorial group. Double-blind randomized with block method. Phase 3 on 74 patients.
Settings and conduct
This study is designed as a double-blind clinical trial. Women who have been referred to the relevant specialist for a bladder tap are randomly assigned to the study until the required sample size is reached according to the inclusion criteria. They are randomly assigned to a number of cranberry drugs and a number of placebos in a block. The dose of cranberry capsules is 500 mg, which the patient takes one capsule every 12 hours for a week before the bladder tap. After the aerodynamic study, within 24 to 72 hours, the first contact is within 24 hours and the second contact is 72 hours later, questions related to the occurrence of burning urination, frequent urination, urgency during defecation, and pain or discomfort in the bladder area are asked from the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals for whom a bladder tap has been requested. Age over 18 years. No previously diagnosed anatomical abnormalities of the urinary tract. No symptoms of vaginitis or cystitis. No asymptomatic bacteriuria. Exclusion criteria: Patient unwillingness to take medication.
Intervention groups
This study is designed as a double-blind clinical trial. Women who have been referred to a specialist for a bladder biopsy will be included in the study. They will be randomly assigned to a number of cranberry drugs and a number of placebos in a block design.
Main outcome variables
Insufficient voiding
Dysuria
Frequent urination
Urgency during defecation
Pain or discomfort in the bladder
History of prolapse
Incontinence surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250503065570N1
Registration date:2025-07-22, 1404/04/31
Registration timing:prospective
Last update:2025-07-22, 1404/04/31
Update count:0
Registration date
2025-07-22, 1404/04/31
Registrant information
Name
Fatemeh Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3435 2018
Email address
f.farahani14000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-26, 1404/05/04
Expected recruitment end date
2026-07-26, 1405/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of cranberry medicine on the prevention of dysuria caused by Urodynamic study A Randomized Clinical Trials
Public title
Investigating the effect of cranberry medicine on the prevention of dysuria caused by Urodynamic study A Randomized Clinical Trials
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People for whom a bladder tape has been requested
Age over 18 years old
Absence of previously diagnosed anatomical abnormalities of the urinary tract
No symptoms of vaginitis or cystitis
Absence of asymptomatic bacteriuria
Exclusion criteria:
Patient's unwillingness to take medication
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the random permutation block method will be used for randomization. For this purpose, a block of 6 will be used. In each block, the letter I (Intervention) is written on three cards and the letter P (Placebo) is written on three cards. To hide the cards, they are placed in an envelope and turned over several times so that their order is not clear. As each participant enters, a card is selected for him and the selected card is set aside. This is done for the next five patients until 6 people are identified. Then, randomization will be done in the same way for the other groups of 6 people to achieve the desired sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study in which neither the researcher nor the patient knows which treatment is assigned to the patient. The statistical consultant performs block randomization and assigns a code to each drug, contacts the pharmacy and announces the type of drug and the code, and then the pharmacy writes the code on the drug and gives it to the patient for whom the specialist doctor has prescribed cranberry.
This study has a placebo and after obtaining informed consent from the patient, some patients are given a placebo and some are given the cranberry drug itself.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Alam Al-Hoda Street . Shahid Shiroodi Street
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2025-04-20, 1404/01/31
Ethics committee reference number
IR.ARAKMU.REC.1404.021
Health conditions studied
1
Description of health condition studied
Dysuria caused by bladder aerodynamics
ICD-10 code
R30.0
ICD-10 code description
Dysuria
Primary outcomes
1
Description
Dysuria after bladder taping
Timepoint
Within 24 to 72 hours, first call within 24 hours and second call 72 hours later.
Method of measurement
Checklist and questions
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Each capsule of Cranfix contains approximately 500 mg of cranberry extract. Since participants are instructed to take 2 capsules per day (one every 12 hours), the total daily dose will be 2 capsules × 500 mg, 1000 mg of cranberry extract per day. Over a 1-week period, they will take a total of 7000 mg of cranberry extract. In order to emphasize the continued use of the capsules, daily telephone calls will be made to the patients in some cases. Cranfix Cranberry Fruit Extract (Vaccinium Macrocarpon L) capsules, 500 mg dose, are manufactured in Gol Daru Company, Isfahan, Soffe Industrial Estate, Iran.
Category
Treatment - Drugs
2
Description
Control group: The placebo control group will be given the same 500 mg cranberry capsule as the original drug and at the same time. Each placebo capsule of Cranfix is approximately 500 mg. Since participants are instructed to take 2 capsules per day (one every 12 hours), the total daily dose of 2 capsules × 500 mg will be 1000 mg per day. Over a 1-week period, they will take a total of 7000 mg. In order to emphasize the continuous use of the placebo capsule, daily telephone calls will be made to the patients in some cases. The placebo capsule of Cranfix Cranberry Fruit Extract (Vaccinium Macrocarpon L), 500 mg, is manufactured in Gol Daru Company, Isfahan, Soffe Industrial Estate, Iran.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghavamzadeh Clinic
Full name of responsible person
Fatemeh Farahani
Street address
Alam Al-Hoda Street , Shahid Shiroodi Street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vice President for Technology Research, Arak University of Medical Sciences
Street address
Shahid Shiroudi Street - Alam Al-Hoda Street
City
Arak
Province
Markazi
Postal code
3816693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maryam Shokrpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alam Al-Hoda Street . Shahid Shiroodi Street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maryam Shokrpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sina Rezaei Ashtiani Hospital . Next to the Faculty of Medicine . Basij Square.
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3836 0000
Fax
Email
it_amiralmomenin@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Farahani
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Alam Al-Hoda Street . Shahid Shiroodi Street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
Email
info@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information available.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available