1. Home
  2. Approved trials
  3. » فارسی

Evaluation of Contractile Radio Frequency(CRF) in the treatment of Female stress urinary incontinence

Protocol summary

Summary
The aim of this study was to investigate the effect of Contractile Radio Frequency on the treatment of urinary incontinence in women with the goal of reducing complications, ease of treatment, and reducing the cost of treatment and improving quality of life. People with urinary incontinence, complete satisfaction to participate in the study, complete Therapeutic and follow-up trends are included in the study. Patients with diabetes, disorders of consciousness, underlying diseases, fecal incontinence, depression, and patients with overactive bladder are excluded from the study process. In a randomized clinical trial, 40 women with Urinary Stress incontinence Investigated by Eurodynamics Have been confirmed were selected and divided into two groups. In each group, 20 patients are enrolled. In the treatment group, the patients will be trained 2 times per week for 12 sessions and 20 minutes each time. The off Contractile Radio Frequency is used in the control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201709258146N22
Registration date: 2017-10-08, 1396/07/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-08, 1396/07/16
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Contractile Radio Frequency(CRF) in the treatment of Female stress urinary incontinence
Public title
The Effect of Radio Frequency on Treatment of Urinary Incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women with urinary incontinence; Full satisfaction for participation in the study; Complete treatment and follow-up;Exclusion criteria; Patients with diabetes; disorders of consciousness; underlying diseases; fecal incontinence; depression; patients with overactive bladder.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Organizational committee of ethics in biomedical research Shahid Beheshti University of Medical Scie
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Postal code
Approval date
2017-09-17, 1396/06/26
Ethics committee reference number
IR.SBMU.REC.1396.111

Health conditions studied

1

Description of health condition studied
stress urinary incontinence
ICD-10 code
N39
ICD-10 code description
Other disorders of urinary system

Primary outcomes

1

Description
The incidence of stress urinary incontinence
Timepoint
Before treatment,two month after the end of treatment
Method of measurement
Eurodynamics

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients undergo Contractile Radio Frequency with 40-20 Watt and frequency of 1-300kHz at pulse for 2 times a week and 12 sessions for 2 months.
Category
Treatment - Other

2

Description
Control group: Patients undergo off Contractile Radio Frequency.All variables including duration of radiation, duration of radiation and the number of treatment sessions in the control group will be exactly the same as the case group, and treatment will be given by the same physician in this group.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Laser Application Research Center in Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Razaghi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Laser Application Research Center in Medical Science
Full name of responsible person
Dr.Mohammad Reza Razaghi
Position
urologist
Other areas of specialty/work
Street address
Shohada Hospital-Tajrish
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Laser Application Research Centre in Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Razaghi
Position
urologist
Other areas of specialty/work
Street address
Shohada Hospital-Tajrish
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Laser Application Research Centre in Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Razaghi
Position
urologist
Other areas of specialty/work
Street address
Shohada Hospital-Tagrish
City
Tehran
Postal code
-
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...