Evaluation of radiation cystitis treatment with intravesical instillation of hyaluronic acid (cystistat)
Design
In this single-blind randomized clinical trial, patients undergoing radiotherapy due to pelvic malignancies and have cystitis symptoms, were randomly assigned to two groups (at least 20) via sealed envelops. In one group, 40 mg (50 cc) of cystistat were injected into the bladder with a vial of 2% lidocaine and one vial of heparin and in the other group cystistat was replaced with 50 cc normal saline, and the solution One hour is kept in the bladder. This solution is injected weekly for up to 4 weeks and then monthly for up to 2 months.
Settings and conduct
all patients in Shohada Tajrish hospital in Tehran that due to pelvis radiation suffered from radiation cystitis included in this one side blind(patients) study.through sealed envelope patients were randomized to two groups and the effect of intravesical acid hyaloronic and normal saline in remission of urinary symptoms was compared
Participants/Inclusion and exclusion criteria
Patients who underwent radiotherapy due to pelvic malignancies and developed with urinary symptoms like hematuria, frequency and chronic pelvic pain has evaluated and patients with history of BPH,neurological and neurosurgical disease,positive urine culture,diuretic drugs consumption has excluded
Intervention groups
in one group 40 milligram(50 cc) cystistat plus one vial of lidocain 2% and one vial of heparin and in the other group 50cc normal saline with one vial of lidocain 2%and one vial of heparin instilled into bladder via catheter and was held in bladder for one hour and this methods repeated for 4 weeks weekly then every month for two months
Main outcome variables
situation of radiation cystitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180218038788N1
Registration date:2018-04-27, 1397/02/07
Registration timing:registered_while_recruiting
Last update:2018-04-27, 1397/02/07
Update count:0
Registration date
2018-04-27, 1397/02/07
Registrant information
Name
amirhossein rahavian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
amirrahavian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of radiation cystitis treatment with intravesical instillation of hyaluronic acid (cystistat)
Public title
evaluation of acid hyaluronic on radiation cystitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients that underwent radiotherapy due to pelvic malignancies and developed with urinary problems such as hematuria, frequency, CPPS
patients did not response to current treatment of cystitis
Exclusion criteria:
history of BPH
positive urine culture
history of neurologic and neurosurgery disease
diuretic drugs consumption
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done from a computer-generated sequence(SAS software), concealed in sequentially numbered, sealed, opaque envelopes, and kept by the ward secretary
Blinding (investigator's opinion)
Single blinded
Blinding description
after explanation of study, all the participants and care providers are blind because patients divided to two groups by sealed envelops and same intervention was done for both groups but with different material.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran Province, Tehran, District 1, Daneshjou Blvd., Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2018-02-21, 1396/12/02
Ethics committee reference number
IR.SBMU.UNRC.1395.78
Health conditions studied
1
Description of health condition studied
Radiation cystitis
ICD-10 code
N30.41
ICD-10 code description
Irradiation cystitis with hematuria
Primary outcomes
1
Description
score of pelvic pain
Timepoint
before intervention and 3, 6 , 9 months after intervention
Method of measurement
visual analogue scale to measure pain
2
Description
urinary frequency
Timepoint
before intervention and 3, 6 , 9 months after intervention
Method of measurement
International Prostate Symptom Score(IPSS)
Secondary outcomes
1
Description
Quality Of Life
Timepoint
before intervention and 3, 6 and 9 months after intervention
Method of measurement
King’s Health Quality of Life Questionnaire
Intervention groups
1
Description
Intervention group: in this group 40 mg(50 cc) cystistat +one vial of lidocaine 2% + one vial of heparin instilled into bladder and reserved one hour in bladder. this solution instilled for four weeks weekly and then monthly for two months
Category
Treatment - Drugs
2
Description
Control group: in this group 50 cc normal saline +one vial of lidocaine 2% + one vial of heparin instilled into bladder and reserved one hour in bladder. this solution instilled for four weeks weekly and then monthly for two months