The assessment of the effect of injection of Botulinum toxin A (Transurethral method) on Benign Prostate Hyperplasia refractory to routine medical treatment in poor surgical candidates
Benign prostate hyperplasia (BPH) is a major etiology of bladder outlet obstruction which can cause bothersome urinary symptoms. Although transurethral resection of prostate (TURP) is an effective and gold standard treatment for BPH, but its effect is not complete and almost 15-25% of patients don’t have long term satisfactory outcomes after TURP. Botulinium toxin A (BoNT-A) reduces acetylcholine release from cholinergic terminals. Injection of BoNT-A in prostate causes apoptosis, inhibition of cellular proliferation and down regulation of α1 A receptors and seems that can reduce urinary symptoms. In this study 10 men with BPH refractory to routine medical treatment and not suitable for surgery will be selected. Data such as prostate volume, PSA, IPSS (International Prostatic Symptom Score), PVR and max flow rate will be recorded then BoNT-A injection in prostate will be done transurethrally. After 3 month variables will be recorded again and compared with previous data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008174582N1
Registration date:2010-09-07, 1389/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-07, 1389/06/16
Registrant information
Name
Ali Hamidi Madani
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1552 5259
Email address
hamidimadani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Guilan University of Medical Sciences
Expected recruitment start date
2010-06-06, 1389/03/16
Expected recruitment end date
2010-08-07, 1389/05/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of the effect of injection of Botulinum toxin A (Transurethral method) on Benign Prostate Hyperplasia refractory to routine medical treatment in poor surgical candidates
Public title
The effect of injection of Botulinum toxin A on Benign Prostatic Hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: male patients older than 50 years, patients with BPH refractory to medical therapy and not suitable for surgery, IPSS (International Prostatic Symptom Score) ≥8. Exclusion criteria: active UTI, previous history of prostate surgery, prostate cancer, acute prostatitis, simultaneous use of drugs such as: Amino glycosides, Cholinergics, Anticholinergics, Androgens, Estrogen, Steroids, history of allergy to BoNT-A, neurologic disease like Parkinson, Myastenia Gravis, Multiple Sclerosis, history of allergy to BoNT.
Age
From 50 years old to 149 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Guilan University of Medical Science
City
Rasht
Postal code
41448-95655
Approval date
2010-05-22, 1389/03/01
Ethics committee reference number
1023
Health conditions studied
1
Description of health condition studied
Benign Prostatic Hyperplasia
ICD-10 code
N40
ICD-10 code description
Hyperplasia of prostate
Primary outcomes
1
Description
International score of prostatic signs & symptoms
Timepoint
before intervention and 3 months after that
Method of measurement
IPSS: International Prostatic Symptom Score
Secondary outcomes
1
Description
maximum urinary flow
Timepoint
before intervention and 3 months after that
Method of measurement
uroflometry
2
Description
prostate volume
Timepoint
before intervention and 3 months after that
Method of measurement
sonography
Intervention groups
1
Description
Transurethral injection of Botulinum in prostate
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Ali Hamidi Madani
Street address
Razi Hospital, Sardar Jangal street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasoul Sobhani
Street address
Guilan University of Medical Sciences
City
Rasht
Grant name
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan 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
Urology Research Center
Full name of responsible person
Dr. Ahmad Enshaei
Position
Co worker/Resident
Other areas of specialty/work
Street address
Razi Hospital
City
Rasht
Postal code
4144895655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
ahmad115@yahoo.com ; urc1384@yahoo.com
Web page address
www.urc.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Ali Hamidi Madani
Position
Assistant Professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
4144895655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc1384@yahoo.com
Web page address
www.urc.ir
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Samaneh Esmaeili
Position
Secretor of Urology Research Center/Bachlor
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
4144895655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
samaneh_815@yahoo.com
Web page address
www.urc.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)