Treatment of interstitial cystitis; clinical effectiveness of hydrodistention with intravesical hyaluronic acid (cystistat®) over hydrodistention alone
We compared the therapeutic effects of bladder hydrodistention alone or together with intravesical cystistat (40mg of sodium hyaluronate in a 50ml vial) in the treatment of interstitial cystitis.
Design
A randomized controlled trial with blinded outcome assessment.The patients were allocated to the intervention (n=12) and control (n=12) groups based on the randomized computer assignment list.
Settings and conduct
This study was conducted in Urology Clinic of Imam Reza Hospital of Mashhad in 2017. Twenty-four female interstitial cystitis patients were selected using clinical examinations and the O`Leary-Sant questionnaire, which was also used for evaluating the effects of the treatment. all the patients filled O`leary saint questionnaire at the baseline, one week, one month and three months after treatment. PASS software was used for generating the random assignment list. The researcher who evaluated the questionnaires and the statistical analyzer were blinded but the doctor and the patients were aware of treatments.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women over 18 years old with intravesical cystitis were included. Exclusion criteria: Patients with a history of other diseases related to the urogenital system, cyclophosphamide use, abdomen or pelvis radiotherapy, and urination frequency less than 8 times a day were excluded from the study.
Intervention groups
Intervention group: Hydrodistention was performed under general anesthesia for 8 minutes. Cystistat® produced by Mylan company was infused into the bladder through a catheter. it was kept in the bladder for 30 minutes, then drained by urinating. This procedure was done weekly for four weeks, then monthly until two months later. Control group: The control group underwent hydrodistention with the same procedure as the intervention group.
Main outcome variables
urgency, frequency, nocturia, dysuria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130811014330N5
Registration date:2018-11-29, 1397/09/08
Registration timing:retrospective
Last update:2018-11-29, 1397/09/08
Update count:0
Registration date
2018-11-29, 1397/09/08
Registrant information
Name
Hamid Reza Rahimi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1800 2288
Email address
rahimihr891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
2017-04-22, 1396/02/02
Actual recruitment end date
2017-07-26, 1396/05/04
Trial completion date
2017-12-01, 1396/09/10
Scientific title
Treatment of interstitial cystitis; clinical effectiveness of hydrodistention with intravesical hyaluronic acid (cystistat®) over hydrodistention alone
Public title
Effectiveness of hyaluronic acid for the treatment of interstitial cystitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Older than 18 years’ old
Previously treated with a daily 25 mg of Amitriptyline for at least 1 month, and did not show any improvement in symptoms.
Exclusion criteria:
History of bacterial cystitis in the last 3 months
History of active genital herpes
History of vaginal cervical or uterine cancer
History of diverticulum
History of cyclophosphamide consumption
History of bladder tuberculosis
History of abdomen or pelvis radiotherapy
Vaginitis symptoms
History of bladder stones
History of symptom relief with antimicrobials or anticholinergics
Frequency of urination less than 8 times a day
History of benign or malignant bladder tumors
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was used.patients were assigned to intervention and control groups using random assignment list generated by PASS software.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the patients and the doctor were aware of the allocated treatment, so blinding was not possible. but the researcher who evaluated the questionnaires and the statistical analyst of the study were completely unaware about the treatment of each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Faculty of Medicine, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.MUMS.fm.REC.1395.456
Health conditions studied
1
Description of health condition studied
Interstitial cystitis / bladder pain syndrome
ICD-10 code
N30.1
ICD-10 code description
Interstitial cystitis (chronic)
Primary outcomes
1
Description
Frequency of urination
Timepoint
Baseline, 1 week, 1 month, and 3 months after intervention
Method of measurement
the O`Leary-Sant questionnaire
2
Description
urgency
Timepoint
Baseline, 1 week, 1 month, and 3 months after intervention
Method of measurement
the O`Leary-Sant questionnaire
3
Description
nocturia
Timepoint
Baseline, 1 week, 1 month, and 3 months after intervention
Method of measurement
the O`Leary-Sant questionnaire
4
Description
dysuria
Timepoint
Baseline, 1 week, 1 month, and 3 months after intervention
Method of measurement
the O`Leary-Sant questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients were provided with instructions needed before hydrodistention and told not to use a diet that exacerbates interstitial cystitis symptoms. If urinary tract infection was diagnosed, the patient was treated with antibiotics for a week. Hydrodistention was performed under general anesthesia. at first, a urologist performed cystoscopy. The bladder was dilated with normal sterile saline for 1-2 minutes. Then the bladder was emptied and refilled to allow the urologist to see the lesions and wounds perfectly. Therapeutic Hydrodistention was continued for another 8 minutes. In the 12 patients of the intervention group, Cystistat® solution (40mg of sodium hyaluronate in a 50ml vial) produced by Mylan company was infused into the bladder through a catheter. patients had to keep the solution in their bladder for at least 30 minutes and place in different positions, then drained it by urinating. This procedure was done weekly for four weeks, then monthly until two months later.
Category
Treatment - Drugs
2
Description
Control group: The 12 patients of the control group were provided with instructions needed before hydrodistention and told not to use a diet that exacerbates interstitial cystitis symptoms. If urinary tract infection was diagnosed, the patient was treated with antibiotics for a week. Hydrodistention was performed under general anesthesia. at first, a urologist performed cystoscopy. The bladder was dilated with normal sterile saline for 1-2 minutes. Then the bladder was emptied and refilled to allow the urologist to see the lesions and wounds perfectly. Therapeutic Hydrodistention was continued for another 8 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Clinic of Imam Reza Hospital
Full name of responsible person
Mohammadreza Darabi Mahboub
Street address
Department of Urology, Imam Reza Hospital, Ebne Sina Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 8946
Email
emamreza@mums.ac.ir
Web page address
http://emamreza.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Quraishi building of MUMS, Daneshghah St, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3854 3031
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Rahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, Mashhad University of Medical Sciences, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3800 2301
Fax
Email
rahimihr@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Rahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, Mashhad University of Medical Sciences, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3800 2301
Fax
Email
rahimihr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Rahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
General Practitioner
Street address
Faculty of Medicine, Mashhad University of Medical Sciences, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3800 2301
Fax
Email
rahimihr@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available