Protocol summary
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Study aim
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To assess the effect of new combined medication “Young Prostate" versus standard treatment on clinical symptoms in patients with benign prostate hypertrophy and overactive bladder
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Design
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This is a randomized clinical trial, in which 64 eligible patients will be randomly assigned to the intervention and control groups
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Settings and conduct
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The eligible patients with benign prostate hypertrophy and overactive bladder referring to the Shahid Beheshti Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age of 40 to 65 years,
Benign prostate hypertrophy,
Overactive bladder,
Exclusion criteria:
History of prostate surgery
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Intervention groups
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Intervention group:
New combined tablet “Young prostate” (containing Trazosin 2 mg, Finasteride 5 mg, and Oxybutynin5 mg) daily for 6 months.
Control group:
Tablets Finasteride 5 mg and Trazosin 2 mg and oxytocin 5 mg daily for 6 months.
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Main outcome variables
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Sexual desire, prostate size
General information
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Reason for update
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The form of the medication was changed from capsule to tablet due to the ease of manufacture.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N386
Registration date:
2021-03-07, 1399/12/17
Registration timing:
prospective
Last update:
2021-03-16, 1399/12/26
Update count:
1
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Registration date
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2021-03-07, 1399/12/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-04-04, 1400/01/15
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Expected recruitment end date
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2021-07-06, 1400/04/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of new combined medication “Young Prostate" versus standard treatment on clinical symptoms in patients with benign prostate hypertrophy and overactive bladder: a randomized clinical trial
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Public title
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Effect of new combined medication “Young Prostate" on clinical symptoms in patients with benign prostate hypertrophy and overactive bladder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 40 to 65 years
Benign prostate hypertrophy
Overactive bladder
Exclusion criteria:
History of prostate surgery
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Age
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From 18 years old to 65 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-01-19, 1399/10/30
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Ethics committee reference number
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IR.UMSHA.REC.1399.872
Health conditions studied
1
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Description of health condition studied
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Benign prostate hypertrophy
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ICD-10 code
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D29.1
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ICD-10 code description
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Benign neoplasm of prostate
Primary outcomes
1
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Description
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Sexual desire
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Timepoint
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Before the intervention and 3 and 6 months after that
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Method of measurement
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By taking history
2
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Description
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Prostate size
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Timepoint
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Before the intervention and 3 and 6 months after that
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Method of measurement
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Using ultrasonography
Intervention groups
1
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Description
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Intervention group: New combined tablet “Young prostate” (containing Trazosin 2 mg, Finasteride 5 mg, and Oxybutynin5 mg) daily for 6 months
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Category
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Treatment - Drugs
2
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Description
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Control group: Tablets Finasteride 5 mg and Trazosin 2 mg and oxytocin 5 mg daily for 6 months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available