Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study

Erectile Dysfunction Clinical Trial

Official title:

A Comparison of Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04179747
• Other study ID #: 0925-0585
• Status: Completed
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: July 24, 2018

Study information

• Verified date: November 2019
• Source: International Islamic University, Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 24, 2018
• Est. primary completion date: July 24, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

1. Men diagnosed with erectile dysfunction

2. Must be in the age range of 18 to 39 years

3. Must be in a stable heterosexual relationship

4. Must not be suffering from any medical or psychiatric illness

Exclusion Criteria:

1. Men not meeting criteria of diagnosis of erectile dysfunction

2. Men not in a heterosexual relationship

3. Men of or above the age of 40 years

4. Men diagnosed with any medical or psychiatric illness or obese men

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Behavioral:
• Cognitive Behavioral Psychotherapy
The Cognitive Behavior Psychotherapy was provided for a period of maximum 3 months.

Drug:
• Sildenafil Citrate 50Mg Tab
The participants in control group arm received Sildenafil Citrate 50mg tablet on demand for a period of maximum 3 months.

Locations

Country	Name	City	State
Pakistan	Ahmad Bilal Private Practice	Bahawalpur	South Punjab

Sponsors (1)

Lead Sponsor	Collaborator
International Islamic University, Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months maximum
Secondary	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.	3 months maximum