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NCT Number: NCT04179747

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

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ahmad Bilal Private Practice

Chak Four Hundred Fifty-four, South Punjab, 63100, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral Psychotherapy

Behavioral

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

Other names: Cognitive Behavior Psychotherapy

Sildenafil Citrate 50Mg Tab

Drug

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

Other names: PDE5i

Primary outcomes

  1. International Index of Erectile Functioning-5

    Time frame: 3 months maximum

    The minimum scale score is 5. The maximum scale score is 25. The higher score indicates better erectile functioning.

Secondary outcomes

  1. Depression, Anxiety, and Stress Scale-21

    Time frame: 3 months maximum

    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.

Sponsors and collaborators

Lead sponsor

International Islamic University, Islamabad

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 27, 2019
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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