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

NCT ID: NCT04179747

Last Updated: 2019-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2018-07-24

Brief Summary

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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.

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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Sexual Dysfunctions, Men Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

The cognitive behavior psychotherapy was administered to participants in this treatment arm.

Group Type EXPERIMENTAL

Cognitive Behavioral Psychotherapy

Intervention Type BEHAVIORAL

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

Control Group

This group received the administration of pharmacotherapy (PDE5i) for treatment of Erectile Dysfunction.

Group Type ACTIVE_COMPARATOR

Sildenafil Citrate 50Mg Tab

Intervention Type DRUG

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

Interventions

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Cognitive Behavioral Psychotherapy

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

Intervention Type BEHAVIORAL

Sildenafil Citrate 50Mg Tab

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

Intervention Type DRUG

Other Intervention Names

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Cognitive Behavior Psychotherapy PDE5i

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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International Islamic University, Islamabad

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Bilal

Principal Investigator, PhD Research Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmad Bilal, MPhil

Role: PRINCIPAL_INVESTIGATOR

International Islamic University, Islamabad, Pakistan

Locations

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Ahmad Bilal Private Practice

Chak Eighty-seven -Twelve Left, South Punjab, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 36353027 (View on PubMed)

Other Identifiers

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0925-0585

Identifier Type: -

Identifier Source: org_study_id