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Comparison of the effect of intravesical injection of Botox with oral tamsulosin 0.4 mg in the treatment of lower urinary tract symptom disorders (LUTS) in patients with symptomatic benign prostatic hyperplasia (BPH).

Protocol summary

Study aim
Comparison of the effect of intravesical injection of Botox with oral tamsulosin 0.4 mg in the treatment of LUTS disorders in patients with symptomatic BPH.
Design
Clinical trial with intervention and control group, with parallel groups, randomized, on 40 patients. Blocking technique will be used for randomization.
Settings and conduct
In this clinical trial study, 40 people with benign prostatic hyperplasia with lower urinary tract symptoms who referred to Imam Khomeini Hospital in Ahvaz were randomly divided into 2 groups of 20 people, the target and control groups were injected with Botox in the area Bladder neck and tamsulosin receive 0.4 mg orally daily. Blinding is not possible and all the names and personal information of the patients will be coded during data collection and will remain completely confidential.
Participants/Inclusion and exclusion criteria
Men with benign prostatic hyperplasia who have lower urinary tract symptoms will be included in the study and people who are allergic to Botox will be excluded from the study.
Intervention groups
The intervention group includes patients with benign prostatic hyperplasia who will undergo botox injection in the bladder neck area. The comparison group includes patients with benign prostatic hyperplasia who will be treated with tamsulosin 0.4 mg orally daily.
Main outcome variables
Total Prostate Specific Antigen,International Prostate Symptom Score, Post-Void Residue, Prostate Volume, Voided Volume, maximum urinary flow rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240409061460N1
Registration date: 2024-04-22, 1403/02/03
Registration timing: prospective

Last update: 2024-04-22, 1403/02/03
Update count: 0
Registration date
2024-04-22, 1403/02/03
Registrant information
Name
Reyhaneh Rahnama
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 2368
Email address
rahnama.reyhane93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravesical injection of Botox with oral tamsulosin 0.4 mg in the treatment of lower urinary tract symptom disorders (LUTS) in patients with symptomatic benign prostatic hyperplasia (BPH).
Public title
Comparison of bladder botox and tamsulosin tablets in the treatment of symptomatic benign prostatic hyperplasia (BPH) patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Prostate volume more than 30 ml 2- Obtaining a score higher than 8 from the International Prostate Symptom Score (IPSS) 3- Serum level total prostate specific antigen (tPSA) less than 10ng/mL 4- maximum urinary flow rate (Qmax) less than 16 ml/s 5- Voided volume (VV) more than 150 ml
Exclusion criteria:
1- Having an active and recurrent urinary tract infection 2- History of previous prostatectomy 3- History of prostate cancer 4- Bladder or prostate stones 5- History of using phenylephrine, pseudoephedrine, imipramine, cholinergic, anticholinergic, estrogen, androgen and steroid since 4 weeks before the intervention 6- Biopsy from 6 weeks before the intervention 7- History of unstable angina pectoris, primary neurological disease that affects bladder function, such as multiple sclerosis, myasthenia gravis, Parkinson's 8- History of BoNT-A intraprostatic administration 9- Taking ASA, warfarin and NSAIDs from 6 days before the intervention 10- History of bladder sensitivity to BoNT-A
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation is done by block method. 5 blocks of 8 are used. In this way, the number of 5 blocks of 8 will be randomly extracted using WIN PEPI software. 8 compounds will be from two groups A (injection group) and group B (oral pill group).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Ahvaz Academic City - Vice-Chancellor for Research and Technology, Jundishapur University of Medical Sciences and Healthcare Services, Ahvaz - ground floor
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-04-06, 1403/01/18
Ethics committee reference number
IR.AJUMS.REC.1403.006

Health conditions studied

1

Description of health condition studied
Benign prostatic hyperplasia
ICD-10 code
D29.1
ICD-10 code description
Benign neoplasm of prostate

Primary outcomes

1

Description
maximum urinary flow rate
Timepoint
Before and 3 months after the intervention
Method of measurement
Uroflowmetry test

2

Description
Total Prostate Specific Antigen
Timepoint
Before and 3 months after the intervention
Method of measurement
ELISA test on blood sample

3

Description
Prostate volume
Timepoint
Before and 3 months after the intervention
Method of measurement
Examination of ultrasound results

4

Description
Prostate symptoms
Timepoint
Before and 3 months after the intervention
Method of measurement
International Prostate Symptom Score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group will be injected with Botox in the bladder neck area.The way to inject Botox is that every 100 international units of Bo-A will be diluted in 2 ml of NT saline. The injection dose will be determined according to the prostate volume. For prostate volume less than 30 cc, between 30 and 60 cc and more than 60 cc, respectively, 100, 200 and 300 international units of BoNT-A under spinal anesthesia in the operation room will be injected in the neck area of ​​the bladder.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group will be treated with tamsulosin 0.4 mg orally once a day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz
Full name of responsible person
Dinyar Khazaeli
Street address
Golestan Blvd., Jundishapur University of Medical Sciences, Ahvaz, Faculty of Medicine
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
khazaeli-d@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoosh Zakerkish
Street address
Ahvaz Academic City - Vice-Chancellor for Research and Technology, Jundishapur University of Medical Sciences and Healthcare Services, Ahvaz - ground floor
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dinyar Khazaeli
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Golestan Blvd., Jundishapur University of Medical Sciences, Ahvaz, Faculty of Medicine
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
khazaeli-d@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dinyar Khazaeli
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Golestan Blvd., Jundishapur University of Medical Sciences, Ahvaz, Faculty of Medicine
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
khazaeli-d@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dinyar Khazaeli
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Golestan Blvd., Jundishapur University of Medical Sciences, Ahvaz, Faculty of Medicine
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
khazaeli-d@ajums.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
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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