Comparing effect of cutaneous posterior tibial nerve stimulation with medical treatment with Solifenacin in patients with overactive bladder
Design
In a randomized controlled clinical trial, 74 patients were included
over activity bladder patients are randomly assigned to two groups of drug therapy and tibial nerve stimulation.
Settings and conduct
This study was performed at the urology clinic of Shahid Beheshti Hospital in Hamadan, Iran. The study participants were randomly divided into two groups, each with 5 mg twice daily for 12 weeks during the preparation period. The other group received treatment twice a week for 12 weeks with posterior tibial nerve stimulation in the posterior region of the medial ankle. PTNS is performed by a TENS device with 20 Hz, 200 cycles / s of normal stimulation for 30 minutes per session. At each session, patients receive a motor response that includes the flexoin plantar toe. Initial results are reported as 3 days of urinary bladder questionnaire results (q-OAB), 3 months after treatment. Complications of treatment will also be reported and reported in all patients. Patients will be followed up two to one and three months after treatment to evaluate outcomes and potential complications.
Participants/Inclusion and exclusion criteria
The target groups in this study are all patients with overactive bladder referred to Beheshti Hospital of Hamedan, with a urinary recurrence complaint were diagnosed based on criteria. Minimum age of 18 years and urine culture negative are inclusion criteria and non-returning patients to follow up of intervention outcome are exclusion criteria
Intervention groups
Intervention group: Patients with overactive bladder treated by posterior tibial nerve stimulation
The control group : Patients with overactive bladder treated with medical treatment with Solifenacin
Main outcome variables
Improve urinary incontinence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N4
Registration date:2019-11-28, 1398/09/07
Registration timing:registered_while_recruiting
Last update:2019-11-28, 1398/09/07
Update count:0
Registration date
2019-11-28, 1398/09/07
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of cutaneous posterior tibial nerve stimulation with medical treatment with Solifenacin in patients with overactive bladder
Public title
treatment of overactive bladder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical Diagnosis of overactive bladder
minimum age of 18 years old
negative result of Urine culture
Exclusion criteria:
pregnant women
People with Pacemaker
Inflammatory or neurological origin
History of spinal cord trauma
Central nervous system lesions
Metabolic disease or genetic syndromes
history of abdominal surgery
History of pelvic fractures
Eurogenital Anomalies
history of taking anticholinergic drugs for six months
Psychological Disorders
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 74 sealed envelopes will be used which in 37 letter M envelope means Medical treatment and in 37 letter S envelope mean tibial nerve stimulation. All envelopes are available for physician, after mixing randomly removed and opened . Depending on whether the envelope contains the letter M or S, the individual will be assigned to the medical treatment or tibial nerve stimulation group.
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 Science
Street address
Shahid Fahmideh Ave, Vice-Chancellor for Research and Technology
City
Hamedan
Province
Hamadan
Postal code
6517838697
Approval date
2019-06-14, 1398/03/24
Ethics committee reference number
IR.UMSHA.REC.1398.237
Health conditions studied
1
Description of health condition studied
Over Active Bladder
ICD-10 code
N32.81
ICD-10 code description
Overactive bladder
Primary outcomes
1
Description
Improved quality of life due to urinary incontinence three months after treatment The outcome of this study is evaluated by a standard questionnaire.
Timepoint
1 and 3 months after treatment
Method of measurement
The q-OAB questionnaire will be used to collect the frequency of urinary frequency, urgency, and urgency incontinence for 3 days. q-OAB is a quality of life questionnaire designed to assess symptoms of health-related symptoms and quality of life (HRQL) in patients with or without incontinence and OAB. q-OAB contains 4 subset include social, interaction, concern, coping and HRQL
Secondary outcomes
1
Description
Improving patients' quality of life is a secondary outcome of this study
Timepoint
1 and 3 months after treatment onset
Method of measurement
Outcoms are measured using the summary form of the Bladder Hyperactivity Questionnaire, which contains 25 questions. The questionnaire consists of two parts: 6 questions (symptoms of bladder hyperactivity) and 19 questions (quality of life associated with bladder hyperactivity).
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
2
Description
Control group: Receiving Solifenacin is given 5 mg twice daily for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
dr Mohammadreza Niko
Street address
Eram Blv, Ghaem Sq, Hamedan, Iran
City
Hamedan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0283
Email
Shahidbeheshti@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr Saeid Bashirian
Street address
Shahid Fahmide Ave
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
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
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan shahid fahmideh street medicine school
City
Hamadan
Province
Hamadan
Postal code
6515974544
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammadreza Niko
Position
Anesthesiology MD
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shahid Fahmideh Ave, Faculty of Medicine
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0092
Fax
Email
mohammadrezanikoo@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
کارمند
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan shahid fahmideh street medicine school
City
Hamadan
Province
Hamadan
Postal code
6515974544
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Objectives and methods of the study can be published
When the data will become available and for how long
From 6 months after printing the results
To whom data/document is available
Medical science researchers
Under which criteria data/document could be used
It is permissible to cite the source
From where data/document is obtainable
Correspondence email
What processes are involved for a request to access data/document