The effect of magnesium hydroxide on urinary symptoms caused by benign prostatic hyperplasia
Design
This was a Phase 3, double blind clinical trial study. Patients and researcher were kept blind.
The sample size was 96. Based on quadruple blocks, sample allocation was performed. We named the intervention group "A" and the control group "B". Blocks were numbered according to the random number table. 49 patients were in the intervention group and 47 patients were in the control group.
Settings and conduct
Patients with benign prostatic hypertrophy referring to Imam Hossein Shahroud Hospital
Participants/Inclusion and exclusion criteria
Criteria for entering the study: 1-Patients aged 55 to 75 with benign prostatic hyperplasia and referring to Imam Hossein Shahroud Hospital 2-Patients Without Absolute Surgery Indication 3-Patients without benign prostatic hyperplasia treatment
Exit criteria Study: 1- Diabetics 2- Patients with discopathy or other neurological diseases that affect the bladder and prostate, and rectum 3- All patients with a history of lower urinary system surgery 4-Patients with a history of neurological anorectal disease 5- Complications of drugs and laxatives, such as diarrhea, etc 6-Smokers and opium users
Intervention groups
Intervention group: Magnesium hydroxide 8% is the main intervention and is administered at a dose of 30 cc per night, and Tamsulosin capsules are given at a dose of 0.4 mg overnight.
control group: All people receive only Tamsulosin capsules, 0.4 mg, every night.
Main outcome variables
Feeling bladder drainage; Repetitive urination in less than 2 hours of bladder emptying; Urinary flow rate; Need for pressure to empty the bladder; Urinary frequency during sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180115038379N1
Registration date:2018-04-09, 1397/01/20
Registration timing:retrospective
Last update:2018-04-09, 1397/01/20
Update count:0
Registration date
2018-04-09, 1397/01/20
Registrant information
Name
Hamed Dashani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3871 2162
Email address
dashani.h@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-07, 1396/11/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of magnesium hydroxide and tamsulosin with tamsulosin alone on urinary symptoms in patients with benign prostatic hyperplasia
Public title
The effect of magnesium hydroxide on urinary symptoms caused by benign prostatic hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients at the age of 55-75 years with benign prostatic hyperplasia referred to Imam Hossein Shahroud Hospital
Patients who do not have an absolute indication of surgery
Patients who have not received the drug for the treatment of benign prostatic hyperplasia
Exclusion criteria:
diabetic patients
Patients with discopathy or other neurological diseases involving the bladder, prostate, anus and rectum
All patients with a history of lower urinary tract surgery
Patients with anorexia nervosa history
Complications following drug and laxative consumption
Smokers and opium users
Age
From 55 years old to 75 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
96
Actual sample size reached:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Sample allocation was performed through block randomization (quadruple blocks). We named the intervention group "A" and the control group "B". Blocks were numbered using random numbers derived from random number table. The entry of individuals into each group was done based on the selected block' number. 49 patients were placed in the intervention group and 47 patients were placed in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial and will be blind to researchers (observers) and patients (subjects)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
next to Haft Tir Square., Shahroud., iran
City
Shahroud
Province
Semnan
Postal code
36147-73947
Approval date
2016-02-23, 1394/12/04
Ethics committee reference number
IR.SHMU.REC.1394.203
Health conditions studied
1
Description of health condition studied
Benign prostate hyperplasia
ICD-10 code
D29.1
ICD-10 code description
Primary outcomes
1
Description
Feeling bladder emptying
Timepoint
Before treatment and 13 weeks after treatment
Method of measurement
Prostate symptom scoring questionnaire
2
Description
Repetitive urination in less than 2 hours of bladder emptying
Timepoint
Before treatment and 13 weeks after treatment
Method of measurement
Prostate symptom scoring questionnaire
3
Description
Urinary flow rate
Timepoint
Before treatment and 13 weeks after treatment
Method of measurement
Prostate symptom scoring questionnaire
4
Description
Need for pressure to empty the bladder
Timepoint
Before treatment and 13 weeks after treatment
Method of measurement
Prostate symptom scoring questionnaire
5
Description
Urinary frequency during sleep
Timepoint
Before treatment and 13 weeks after treatment
Method of measurement
Prostate symptom scoring questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Magnesium hydroxide 8% is the main intervention and is administered at a dose of 30 cc per night, and tamsulosin capsules are given at a dose of 0.4 mg overnight.
Category
Treatment - Drugs
2
Description
Control group: All people receive only tamsulosin capsule, 0.4 mg, every night
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Training and Therapy Hospital in Shahrood