Comparison of the effectiveness of the three treatment methodes; transecutaneous nerve stimulation by constant parameters, transecutaneous nerve stimulation by variasble parameters and treatment by Solifenacin
Comparison of the effect of three transcutanese tibial transurethomyelation methods with constant parameters (cTTNS) and variable parameters (vTTNS) and sulfinazin (SOL) in the treatment of urinary incontinence in postmenopausal women over 50 years of age
Design
Three arm parallel group randomised trial without blinded postoperative care and outcome assessment
Settings and conduct
The population under study is postmenopausal women with administrative incontinence who are randomly selected into three groups from among the patients referred to the clinics of the Hamadan University of Medical Sciences who have entered the study.CTTNS group: Tibial nerve stimulation with frequency of 20 Hz and 200 μs duration. VTTNS group: Initial tibial tibial stimulation with initial frequency of 20 Hz and initial 200 microsecond duration, which dipped the frequency in the frequency from 20 Hz to 14 Hz, and the duration increased to 300 microseconds and returned to the first state within two seconds. SOL group: patients take 5 mg of sulfinazin for 6 weeks every day.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Postmenopausal women
2- Age over 50 years
3- Urine excretion at least 8 times a day, based on history or voiding diary
4- More than once, the episode was an urgency with or without discretion
Exclusion criteria:
Sensitivity to sulfenacin or its elements
Urinary retention
Neuropathy
Intervention groups
CTTNS group: Tibial nerve stimulation with frequency of 20 Hz and 200 μs duration
VTTNS group: Initial tibial tibial stimulation with initial frequency of 20 Hz and initial 200 microsecond duration, which dipped the frequency in the frequency from 20 Hz to 14 Hz, and the duration increased to 300 microseconds and returned to the first state within two seconds
SOL group: patients take 5 mg of sulfinazin.
Main outcome variables
- Severity of incontinence
- Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190202042581N2
Registration date:2019-06-20, 1398/03/30
Registration timing:prospective
Last update:2019-06-20, 1398/03/30
Update count:0
Registration date
2019-06-20, 1398/03/30
Registrant information
Name
Mohammad Reza Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3423 0949
Email address
m.asadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of the three treatment methodes; transecutaneous nerve stimulation by constant parameters, transecutaneous nerve stimulation by variasble parameters and treatment by Solifenacin
Public title
Comparison of the effectiveness of the three treatment methodes; transecutaneous nerve stimulation by constant parameters, transecutaneous nerve stimulation by variasble parameters and treatment by Solifenacin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal women
Age over 50 years
Urine excretion at least 8 times a day, based on history or voiding diary
ore than once, the episode was an urgency with or without discretion
Exclusion criteria:
Sensitivity to sulfenacin or its elements
Urinary retention
Gastric retention
Neuropathy
Uncontrolled narrow glaucoma angle
Age
From 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Random block method will be used to allocate patients to treatment groups.Packed packs will be used to hide. So that we have 48 envelopes in the package with only one preset code on it and there are no symptoms of the type of treatment on it.So when the patient came to the clinic. The therapist will receive a code from the researcher stamped on one of the envelopes in the package.After opening the envelope by the therapist, the type of treatment will be determined and the treatment will be assigned to the patient.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Research and Technology Vice-Chancellor, Hamedan University of Medical Sciences, Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2019-06-15, 1398/03/25
Ethics committee reference number
IR.UMSHA.REC.1398.217
Health conditions studied
1
Description of health condition studied
Women's urgent incontinence
ICD-10 code
N39.41
ICD-10 code description
Urge incontinence
Primary outcomes
1
Description
Severity of incontinence
Timepoint
At the beginning of the study and 6 weeks after starting treatment
Method of measurement
OABS questionnaire
2
Description
Quality of life
Timepoint
At the beginning of the study and 6 weeks after starting treatment
Method of measurement
Quality of Life questionnaire
Secondary outcomes
1
Description
The frequency of urinary leakage
Timepoint
At the beginning of the study and 6 weeks after starting treatment
Method of measurement
Patient report
2
Description
Frequent feelings of urgency
Timepoint
At the beginning of the study and 6 weeks after starting treatment
Method of measurement
Patient report
Intervention groups
1
Description
Intervention group: CTTNS group: Tibial nerve stimulation with frequency of 20 Hz and 200 μs duration
Category
Rehabilitation
2
Description
Intervention group: VTTNS group: Initial tibial tibial stimulation with initial frequency of 20 Hz and initial 200 microsecond duration, which dipped the frequency in the frequency from 20 Hz to 14 Hz, and the duration increased to 300 microseconds and returned to the first state within two seconds
Category
Rehabilitation
3
Description
Intervention group: SOL group: patients take 5 mg of sulfinazin for 6 weeks every day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation clinic of mobasher
Full name of responsible person
Hojat Radinmehr
Street address
mahdieh Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3826 2435
Email
h.radinmehr@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamedan, In front of Mardom Park, Hamedan University of Medical Sciences, Research and Technology Vice-Chancellor
City
hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 0717
Email
bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Hojat Radinmehr
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of physical therapy, Rehabilitation Schools, Hemedan Univercity of medical Sciences, Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1571
Email
h.radinmehr@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hojat Radinmehr
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of physical therapy, Rehabilitation Schools, Hemedan Univercity of medical Sciences, Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1571
Email
h.radinmehr@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hamedan univercity of medical sciences, Famideh Blvd,
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3423 0949
Fax
Email
m.asadi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD