Assessment of the effect of transurethral intraprostatic injection of botolinum toxin type A on males with chronic pelvic pain syndrome & refractory to conventional therapy referred to Razi hospital
Chronic pelvic pain syndrome (CPPS) has substituted the previously used classification of nonbacterial prostatitis & prostatodynia.
Although medical approaches have reduced CPPS symptoms, thus the objective of the current a pilot double blind & randomized placebo-controlled clinical trial study is to evaluate the safety & efficacy of transurethral intraprostatic injection of BoNT-A for the treatment of men diagnosed with CPPS refractory to conventional medical therapies.
60 Men referred to Razi Hospital with a clinical diagnosis of CPPS and refractory to 4-6 weeks convetional medical therapy will be treated with intraprostatic BoNT-A or placebo(Nl.Saline) & followed for 1 week (complications),1 & 3 months (primary efficacy analyses),6months (long term follow-up) for responders.
Patients undergo baseline evaluation including history, clinical examination, NIH-CPSI, IPSS ,VAS score & QoL score questionairs , sonography, 4-Glass test & Uroflowmetry.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208051853N8
Registration date:2012-09-08, 1391/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-08, 1391/06/18
Registrant information
Name
Siavash Falahatkar
Name of organization / entity
Urology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
urc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center, Guilan University of Medical Sciences
Expected recruitment start date
2012-06-04, 1391/03/15
Expected recruitment end date
2013-09-06, 1392/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of transurethral intraprostatic injection of botolinum toxin type A on males with chronic pelvic pain syndrome & refractory to conventional therapy referred to Razi hospital
Public title
Effect of transurethral intraprostatic injection of botolinum toxin type A on chronic pelvic pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age>18; clinical diagnosis of CPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least the past 3 months without evidence of bacterial infection; aggregate score of greater than or equal to 10 on the NIH-CPSI questionair; failed empirical therapy for 4-6 weeks
Exclusion criteria: history of prostate; bladder or urethra cancer; pelvic radiation or systemic chemotherapy or intravesical chemotherapy; neurological disease affectin g the bladder; previous intraprostatic injection of BoNT-A; PVR>200 cc; history of prostate surgery; urinary catheter; cystostomy or nephrostomy; penile or urinary sphincter implants; PSA > age- specific range; coagulopathies; during the last month: intake of antibiotics,alpha-receptor blockers,anticholinergics; intake of analgesics containing opioids; during the last 3 months:documented urinary infection,epididymitis,positive urinary cultures,STD; during the last 6 months:5-alpha reductase inhibitor; during the last 12 months: genital herpes, not adjustable HTN; angina pectoris; heart failure; status post MI; coronary bypass surgery or coronary dilatation; during the last 24 months: cerebral insult; serum creatinin >2 mg/dl; hypersensitivity concerning any substances of content of BoNT-A or myasthenia gravis; abuse of drugs or alcohol during last 5 years
Age
From 18 years old to 149 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Namjoo Street
City
Rasht
Postal code
Approval date
2012-05-23, 1391/03/03
Ethics committee reference number
1910095609
Health conditions studied
1
Description of health condition studied
chronic pelvic pain syndrome
ICD-10 code
N41.8
ICD-10 code description
Other inflammatory diseases of prostate
Primary outcomes
1
Description
Chronic pelvic pain syndrome
Timepoint
before injection, 1,3,6 months after injection
Method of measurement
NIH-CPSI questionnaire
Secondary outcomes
1
Description
IPSS total score
Timepoint
before injection, 1,3,6 months after injection
Method of measurement
IPSS questionnaire
2
Description
patient's pain scaling
Timepoint
before injection, 1,3,6 months after injection
Method of measurement
Visual Analog Scale score questionnaire
3
Description
patient's quality of life scoring
Timepoint
before injection, 1,3,6 months after injection
Method of measurement
QoL score questionnaire
4
Description
Max flow rate
Timepoint
before injection, 1,3,6 months after injection
Method of measurement
Uroflowmeter
Intervention groups
1
Description
transurethral intraprostatic injection of 20 U/ML Botolinum Toxsin type-A
Category
Treatment - Drugs
2
Description
transurethral intraprostatic injection of 0.9% normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Elahe Shahab (Rezident)
Street address
Urology Research Center, Razi Hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Siavash Falahatkar
Street address
Razi Hospital, Urology Research Center
City
Rasht
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Center
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. Elahe Shahab
Position
Co worker/Resident
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
Phone
+98 13 1552 5259
Fax
Email
Shah3000us@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Siavash Falahatkar
Position
Proffesor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Samaneh Esmaeili
Position
Bachlor/ Accountant of Urology Research Center
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc@gums.ac.ir; samaneh_815@yahoo.com
Web page address
www.urology.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)