Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Cognitive Behavioral Psychotherapy
Sildenafil Citrate 50Mg Tab
Sponsored by
About this trial
This is an interventional other trial for Erectile Dysfunction focused on measuring Sexual Dysfunctions, Men Health
Eligibility Criteria
Inclusion Criteria:
- Men diagnosed with erectile dysfunction
- Must be in the age range of 18 to 39 years
- Must be in a stable heterosexual relationship
- Must not be suffering from any medical or psychiatric illness
Exclusion Criteria:
- Men not meeting criteria of diagnosis of erectile dysfunction
- Men not in a heterosexual relationship
- Men of or above the age of 40 years
- Men diagnosed with any medical or psychiatric illness or obese men
Sites / Locations
- Ahmad Bilal Private Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Control Group
Arm Description
The cognitive behavior psychotherapy was administered to participants in this treatment arm.
This group received the administration of pharmacotherapy (PDE5i) for treatment of Erectile Dysfunction.
Outcomes
Primary Outcome Measures
International Index of Erectile Functioning-5
The minimum scale score is 5. The maximum scale score is 25. The higher score indicates better erectile functioning.
Secondary Outcome Measures
Depression, Anxiety, and Stress Scale-21
The scale has three sub-scales.
Depression sub scale, Minimum Score: Zero; Maximum Score: 42
Anxiety sub scale, Minimum Score: Zero; Maximum Score: 42
Stress sub scale, Minimum Score: Zero; Maximum Score: 42 The lowest scores on each of the sub scales indicate better functioning, the higher scores on each sub scale indicate a worse outcome.
Full Information
NCT ID
NCT04179747
First Posted
November 24, 2019
Last Updated
November 26, 2019
Sponsor
International Islamic University, Islamabad
1. Study Identification
Unique Protocol Identification Number
NCT04179747
Brief Title
Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study
Official Title
A Comparison of Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
July 24, 2018 (Actual)
Study Completion Date
July 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Islamic University, Islamabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. The study was randomized controlled trial with two arms involving a control group. The study was conducted with an aim of pilot and feasibility study to evaluate the efficacy and suitability of cognitive behavior psychotherapy with individuals suffering from erectile dysfunction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Sexual Dysfunctions, Men Health
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
The cognitive behavior psychotherapy was administered to participants in this treatment arm.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
This group received the administration of pharmacotherapy (PDE5i) for treatment of Erectile Dysfunction.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Psychotherapy
Other Intervention Name(s)
Cognitive Behavior Psychotherapy
Intervention Description
The Cognitive Behavior Psychotherapy was provided for a period of maximum 3 months.
Intervention Type
Drug
Intervention Name(s)
Sildenafil Citrate 50Mg Tab
Other Intervention Name(s)
PDE5i
Intervention Description
The participants in control group arm received Sildenafil Citrate 50mg tablet on demand for a period of maximum 3 months.
Primary Outcome Measure Information:
Title
International Index of Erectile Functioning-5
Description
The minimum scale score is 5. The maximum scale score is 25. The higher score indicates better erectile functioning.
Time Frame
3 months maximum
Secondary Outcome Measure Information:
Title
Depression, Anxiety, and Stress Scale-21
Description
The scale has three sub-scales.
Depression sub scale, Minimum Score: Zero; Maximum Score: 42
Anxiety sub scale, Minimum Score: Zero; Maximum Score: 42
Stress sub scale, Minimum Score: Zero; Maximum Score: 42 The lowest scores on each of the sub scales indicate better functioning, the higher scores on each sub scale indicate a worse outcome.
Time Frame
3 months maximum
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men diagnosed with erectile dysfunction
Must be in the age range of 18 to 39 years
Must be in a stable heterosexual relationship
Must not be suffering from any medical or psychiatric illness
Exclusion Criteria:
Men not meeting criteria of diagnosis of erectile dysfunction
Men not in a heterosexual relationship
Men of or above the age of 40 years
Men diagnosed with any medical or psychiatric illness or obese men
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Bilal, MPhil
Organizational Affiliation
International Islamic University, Islamabad, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmad Bilal Private Practice
City
Bahāwalpur
State/Province
South Punjab
ZIP/Postal Code
63100
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36353027
Citation
Bilal A, Abbasi NUH. Development of an indigenous manual of cognitive behavior sex therapy for young men. J Family Med Prim Care. 2022 Aug;11(8):4127-4130. doi: 10.4103/jfmpc.jfmpc_1892_21. Epub 2022 Aug 30.
Results Reference
derived
Learn more about this trial
Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study
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