Evaluation of the Effectiveness Biofeedback compared with Electrical Stimulation in Patient with Sexual Dysfunction
Design
Two arm parallel group Semirandomised trial .
Settings and conduct
Patient with Sexual Dysfunction who Visit Emam Reza Hospital, Tehran are divided in Semirandomized manner in Two Group Biofeedback and Electrical Stimulation and have Therapy for 12 session
Participants/Inclusion and exclusion criteria
Stress Incontinency and Sexual Dysfunction, married, No Existence History of Systemic and Psychollogic Illness, No Existence Pelvic Floor Surgery, Absence Pelvic Floor prolapse grade3,4, Absence Use of Psychoaffective drugs
Intervention groups
Two Groups of Biofeedback and Electrical Stimulation
Comparison of the Effectiveness Biofeedback with Electrical Stimulation in Improving Patient with Sexual Dysfunction
Public title
Evaluation of the Effect Biofeedback and Electrical Stimulation in Sexual Dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Stress incontinency and Sexual Dysfunction
married
Exclusion criteria:
No Existence Systemic and Psychologic Illness
No existence History of Pelvic Floor surgery
No existence Pelvic Organ Prolapse grade3,4
Absence Psychoaffective drugs use
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Actual sample size reached:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
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 َAja University of Medical Sciences
Street address
Emam Reza Hospital, E,temadzadeh Ave, west Fatemi Ave, Tehran city
City
Tehran
Province
Tehran
Postal code
1411718546
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
IR.AJAUMS.REC.1396.106
Health conditions studied
1
Description of health condition studied
Stress incontinency, Sexual Dysfunction
ICD-10 code
N81.2
ICD-10 code description
Incomplete uterovaginal prolapse
Primary outcomes
1
Description
Sexual Dysfunction Score in FSFI Questionarie
Timepoint
Sexual Dysfunction Score at initial of therapy and 1,,3 monthes after intervention
Method of measurement
FSFI Questionarie
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Biofeedback
Category
Treatment - Other
2
Description
Intervention group: Electrical Stimulation
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Behnaz Aalaie
Street address
Emam Reza Hospital,E,temadzade Ave, West Fatemi Ave, Tehran city
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
aalaie_behnaz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Sharif Najafi
Street address
Emam reza Hospital, E,temadzadeh AVE, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8802 8350
Email
aalaie_behnaz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Behnaz Aalaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza Hospital, E,temadzadeh Ave, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8802 8350
Email
ethics@ajaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Behnaz aalaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza Hospital, E,temadzadeh Ave, West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+92 1888028350
Email
ethic@ajaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Behnaz Aalaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza Hospital, E,temadzadeh Ave, west Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8802 8350
Email
ethics@ajaums.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
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