Determining the effect of protokine therapy in the treatment of painful bladder syndrome/interstitial cystitis
Design
In the current pilot study, 10 patients diagnosed with BPS/IC in Imam Reza Hospital, Tabriz, who did not respond to medical treatment, will be included in the study.
Settings and conduct
The study will be conducted as a pilot study on 10 volunteer patients suffering from painful bladder syndrome/interstitial cystitis, and there will be no randomization and blinding, and the before and after values will be compared.
Participants/Inclusion and exclusion criteria
All patients with painful bladder syndrome/interstitial cystitis who are resistant to first, second, and third-line treatment (Botox injection).
Patients who have the Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) questionnaire completed by the specialist in the file
Patients who have urodynamic evaluation before injection
Intervention groups
10 patients diagnosed with BPS/IC who did not respond to medical treatment, will be included in the study. On the morning of the injection, 10 cc of blood is taken from the person (using a protokine syringe) and incubated at 37 degrees Celsius for 6-9 hours and centrifuged at 5000 rpm for 6 minutes. Finally, 4.5 to 5 cc of plasma is obtained, which is separated from the syringe using a 0.02 serum filter and ready for use. The patient undergoes general or local anesthesia for protokine injection. Cystoscopy is performed using a 19f rigid cystoscope in the lithotomy position. After the bladder is filled with 150 ml of liquid, 5 cc of Protokine is injected into 10 to 20 areas in the bladder wall of each patient. The injection is performed using a 27-gauge disposable needle. The injection is done in the entire wall of the bladder.
Main outcome variables
Response rate to treatment based on BPIC-SS questionnaire scores in patients before and after treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130306012728N9
Registration date:2023-11-05, 1402/08/14
Registration timing:registered_while_recruiting
Last update:2023-11-05, 1402/08/14
Update count:0
Registration date
2023-11-05, 1402/08/14
Registrant information
Name
Sakineh Hajebrahimi
Name of organization / entity
Urology Department, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7328
Email address
ebrahimis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-03, 1402/06/12
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Protokin therapy in the management of painful bladder syndrome/interstitial cystitis: A pilot study
Public title
Protokin therapy in the management of painful bladder syndrome/interstitial cystitis: A pilot study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with painful bladder syndrome/interstitial cystitis who were resistant to first, second and third line treatment (Botox injection).
Patients who had urodynamic evaluation before injection
Exclusion criteria:
Lack of consent to participate in the study
Age
From 18 years old
Gender
Both
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Center for Evidence-based Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran, Azadi Street- Golgasht Ave, Tabriz, East Azarbaijan, Iran.
Determining the level of patients' satisfaction with the intervention
Timepoint
Before and 1 and 3 months after injection
Method of measurement
Based on the evaluation checklist, the patient's satisfaction with the procedure is measured from completely satisfied to completely dissatisfied: the evaluated questions include: completely satisfied, somewhat satisfied, dissatisfied, completely dissatisfied
3
Description
Determining the amount of side effects in patients
Timepoint
1 and 3 months after injection
Method of measurement
Checklist for any side effects
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Protokin therapy. 10 cc of blood is taken from the patient (using a protokine syringe) and incubated at 37 oc for 6-9 hours and centrifuged at 5000 rpm for 6 minutes. Finally, 4.5 to 5 cc of plasma is obtained, which is separated from the syringe using a 0.02 serum filter and ready for use. In order to inject protokine, the patient will be under general or local anesthesia. Cystoscopy is performed using a 19f rigid cystoscope in the lithotomy position. After the bladder is filled with 150 ml of fluid, 5 cc of Protokine is injected into 10 to 20 areas in the bladder wall of each patient. The injection is performed using a 27-gauge disposable needle. The injection is done in the entire wall of the bladder.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Sakineh Hajebrahimi
Street address
Research Center for Evidence-based Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran, Azadi Street- Golgasht Ave, Tabriz, East Azarbaijan, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3334 2219
Fax
+98 41 3334 2219
Email
ebrahimis@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahbi
Street address
دانشگاه علوم پزشکی تبریز
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3334 2219
Email
ebrahimis@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh hajebrahimi
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Research Center for Evidence-based Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran, Azadi Street- Golgasht Ave, Tabriz, East Azarbaijan, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3334 2219
Email
hajebrahimis@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Hajebrahimi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Research Center for Evidence-based Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran, Azadi Street- Golgasht Ave, Tabriz, East Azarbaijan, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3334 2219
Email
hajebrahimis@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Hajebrahimi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Research Center for Evidence-based Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran, Azadi Street- Golgasht Ave, Tabriz, East Azarbaijan, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3334 2219
Email
hajebrahimis@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data on the main outcome will be published
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to help scientific progress in the field of research
From where data/document is obtainable
Sakineh Hajebrahimi
ebrahimis@tbzmed.ac.ir
What processes are involved for a request to access data/document
Scientific approval of the applicant by Tabriz University of Medical Sciences