Evaluation of the increasing effect of gabapentin supplementation on standard (anticholinergic) treatment in controlling stimulus symptoms after double J stent placement in ureteral stone patients
Evaluation of gabapentin supplementation on standard treatment in stimulus symptoms after double J stent in ureteral stone patients
Design
IRCT with control group, with parallel groups, one-way blind, randomized, phase 2 on 150 patients. it's method was Envelope.
Settings and conduct
Study will be performed in the urology department of Imam Reza Hospital. Ureteral stones Patients and TUL treatment with double J catheter, are studied. there are two groups of intervention by random allocation method. First one is treated with anticholinergics and gabapentin 100 and the second is treated with anticholinergics and placebo. 2 weeks later, the results of irritating symptoms are evaluated by using questionnaire (USSQ).
Participants/Inclusion and exclusion criteria
Patients with unilateral ureteral stones with more than 15 mm
Having a double J catheter
Over 18 years old
Chronic use (more than 3 months) of alpha-blocker and analgesic drugs, history of neurogenic bladder, recurrent urinary tract infection or chronic pelvic pain, patient dissatisfaction, discontinuation during study, people who are contraindicated in gabapentin. High risk group due to drug drowsiness
Intervention groups
Intervention group: Administration of anticholinergic drugs and gabapentin 100 1 per day for ureteral stones patients whom double J stent has been used
Control group: Prescribing anticholinergic and placebo drugs 1 per day for ureteral stones patients whom double J stent has been used
Main outcome variables
Stimulus symptoms are recorded and evaluated in all studied patients based on a questionnaire 2 weeks after the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170417033489N8
Registration date:2021-07-05, 1400/04/14
Registration timing:registered_while_recruiting
Last update:2021-07-05, 1400/04/14
Update count:0
Registration date
2021-07-05, 1400/04/14
Registrant information
Name
Salman Soltani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2553
Email address
soltanis@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the increasing effect of gabapentin supplementation on standard (anticholinergic) treatment in controlling stimulus symptoms after double J stent placement in ureteral stone patients
Public title
The effect of gabapentin supplementation in ureteral stone patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unilateral ureteral stones more than 15 mm in diameter who have undergone TUL lithotripsy
Patients should be over 18 years old
A double G catheter is installed for them
Exclusion criteria:
Chronic use (more than 3 months) of alpha-blocker and analgesic drugs
History of neurogenic bladder
Recurrent urinary tract infections
Chronic pelvic pain
Patient dissatisfaction
Leaving the study during the study process
People who are contraindicated in gabapentin
History of previous allergy to gabapentin
Pregnancy
Breastfeeding
Liver failure
Renal failure
People who are in the high-risk group due to the drowsiness complication of the drug
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
After the visit of each patient with inclusion criteria, an envelope is taken in order and according to the code written in it (for example a / b) the patient is placed in one of two groups
Blinding (investigator's opinion)
Single blinded
Blinding description
After the visit of each patient with inclusion criteria, an envelope is taken in order and according to the code written in it (for example a / b) the patient is placed in one of two groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad Ethics Committee of the Medical School
Street address
Department of Knowledge & Health, Shahid Fakouri blvd, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Approval date
2020-09-30, 1399/07/09
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.343
Health conditions studied
1
Description of health condition studied
ureteral stone disease
ICD-10 code
Z96.0
ICD-10 code description
Presence of urogenital implants
Primary outcomes
1
Description
Score obtained based on the patient's irritating symptoms questionnaire
Timepoint
Before intervention and 14 days after gabapentin
Method of measurement
ureteral stent symptom questionnaire (USSQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treated with anticholinergics and gabapentin 100 mg orally once daily. Solifenacin 5 mg orally is used as an anticholinergic drug. After 2 weeks from the start of treatment, the results of improving the irritating symptoms are re-evaluated using the Persian version of the ureteral stent symptom questionnaire (USSQ). In order to record other information such as patients' personal information, medical records and possible drug side effects during the study (dry mouth, hot flashes, temporary loss of balance, headache, drowsiness, body aches, etc.) from a simple design checklist Will be used by researchers.
Category
Prevention
2
Description
Control group: Second, they are treated with anticholinergics and placebo with the same prescription as the intervention group. and 5 mg oral sulfinacin is used as an anticholinergic drug.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Salman Soltani
Street address
Margin of Imam Reza Square, Ibn Sina Blvd, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
soltanis@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Taffaghodi
Street address
Department of Knowledge and Health, Fakouri Blvd, Mahhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3858 3885
Email
soltanis@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
Dr.Salman Soltani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Department of Urology, on the edge of Imam Reza Square, Ibne Sina Blvd, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
soltanis@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Salman Soltani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Emam Reza hospital, on the edge of Imam Reza Square, Ibn Sina St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
soltanis@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Salman Soltani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Department of Urology, Imam Reza hospital, Ibn Sina St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
soltanis@mums.ac.ir
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
Yes - There is 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
Title and more details about the data/document
Only part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
Start of the access period three months after the publication of the results
To whom data/document is available
Academic and scientific institutions
Under which criteria data/document could be used
by sending an email
From where data/document is obtainable
by email
soltanis@mums.ac.ir
What processes are involved for a request to access data/document