Comparison of the effect of cognitive-behavioral therapy and treatment with sildenafil in the treatment of arousal and orgasm disorders, sexual satisfaction and marital satisfaction
Present study has been performed with the aim to evaluate the effect of treatment with sildenafil and cognitive-behavioral therapy on female sexual function and to compare these two as well. In this study, 86 married women with arousal and orgasm disorder were randomly divided into two groups of treatment with sildenafil and cognitive-behavioral therapy. One group will be treated with 50 mg oral sildenafil one hour prior to the intercourse and the other group will receive 8 sessions of cognitive-behavioral therapy. Study outcomes including sexual function index, sexual satisfaction and marital satisfaction are evaluated through three questionnaires, before the start of the treatment and at 4, 8 and 12 weeks after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070318338N1
Registration date:2014-08-03, 1393/05/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-03, 1393/05/12
Registrant information
Name
Fatemeh Mehrzad
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
fateme_mehrzad@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of cognitive-behavioral therapy and treatment with sildenafil in the treatment of arousal and orgasm disorders, sexual satisfaction and marital satisfaction
Public title
Comparison of the effect of cognitive-behavioral therapy and treatment with sildenafil on sexual function and marital satisfaction in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being in a monogamous relationship with only one guy for at least 6 months prior to participation in the study; The presence of sexual functioning disorders diagnosed by a psychiatrist. Exclusion criteria: symptomatic heart diseases; untreated psychiatric disorders; spinal cord injuries; uncontrolled diabetes mellitus; history of drug abuse; alcohol use; stroke during at least the six previous months; heart attack during at least the six previous months; physical problems of female reproductive tract diagnosed by the gynecologist; those who do not have the willingness to have sex due to familial conflicts
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
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
Kashan University of Medical Sciences ethics committee
Street address
Vice chancellor for research, Kashan Medical Sciences complex, Ghotbe Ravandi Blvd.,
City
Kashan
Postal code
Approval date
2013-10-26, 1392/08/04
Ethics committee reference number
29/5/1/460/پ
Health conditions studied
1
Description of health condition studied
female sexual dysfunction
ICD-10 code
F52.8
ICD-10 code description
other sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Sexual desire
Timepoint
before the intervention/4weeks after the intervention/8weeks after the intervention/12weeks after the intervention(end of intervention)
Method of measurement
FSFI standardized questionnaire
2
Description
Sexual excitment
Timepoint
before the intervention/4weeks after the intervention/8weeks after the intervention/12weeks after the intervention(end of intervention)
Method of measurement
FSFI standardized questionnaire
3
Description
Vaginal lubrication
Timepoint
before the intervention/4weeks after the intervention/8weeks after the intervention/12weeks after the intervention(end of intervention)
Method of measurement
FSFI standardized questionnaire
4
Description
Orgasm
Timepoint
before the intervention/4weeks after the intervention/8weeks after the intervention/12weeks after the intervention(end of intervention)
Method of measurement
FSFI standardized questionnaire
5
Description
Sexual satisfaction
Timepoint
before the intervention/4weeks after the intervention/8weeks after the intervention/12weeks after the intervention(end of intervention)
Method of measurement
FSFI standardized questionnaire
6
Description
Dysparonia
Timepoint
before the intervention/4weeks after the intervention/8weeks after the intervention/12weeks after the intervention(end of intervention)
Method of measurement
FSFI standardized questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Treatment with 50 mg sildenafil orally one hour before intercourse
Category
Treatment - Drugs
2
Description
Cognitive-behavioral therapy weekly for 8 sessions was conducted by a female therapist with a PhD in clinical psychology according to the following protocol: from the first to the third session: Introduction, general understanding of different types of sexual disorders and their effect on marital quality, explaining the value and importance of its treatment, determining the main problem, evaluating the method of intercourse, communication skills training, provide sex education and sexual knowledge, identifying irrational thoughts and beliefs and correct assertiveness training/ from the fourth to the sixth session: Cognitive restructuring and changing negative attitudes toward sexual issues, type one sensory concentration, type two sensory concentration, training Kegel exercises, using educational tools, penetration without orgasm, relaxation techniques to minimize everyday-life anxiety/ the seventh and the eighth sessions: the turning point maneuver, intercourse and orgasm, problem solving skills training and its application in everyday-life to minimize the distressing situations, summing up the points made during therapy sessions, elucidating the likelihood of recurrence of symptoms after treatment and responding correctly at the time of symptoms recurrence
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Kargarnejad Hospital
Full name of responsible person
Dr.Fatemeh Mehrzad
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Vice Chancellor for research, Pezeshk Blvd., Ghotbe Ravandi Blvd.
City
Kashan
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, Kashan University of Medical Sciences