Penile Prosthesis in Patients With Erectile Dysfunction

NCT ID: NCT03466619

Last Updated: 2018-03-15

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

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-01

Study Completion Date

2027-12-01

Brief Summary

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Erectile dysfunction (ED) is defined as the persistent inability to attain and or maintain an erection sufficient to permit satisfactory sexual performance

Detailed Description

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In the literature, well- designed studies evaluating safety and efficacy of inflatable penile prosthesis (IPP) is lacking. So, this series aimed at investigating this prospectively.

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

inflatable penile prosthesis (IPP)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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inflatable penile prosthesis (IPP)

inflatable penile prosthesis (IPP)

Group Type EXPERIMENTAL

inflatable penile prosthesis (IPP)

Intervention Type DEVICE

inflatable penile prosthesis (IPP)

Interventions

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inflatable penile prosthesis (IPP)

inflatable penile prosthesis (IPP)

Intervention Type DEVICE

Other Intervention Names

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penile prosthesis (IPP)

Eligibility Criteria

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Inclusion Criteria

* Patients complaining of ED with contraindication or failure of medical treatment

Exclusion Criteria

* Patients lacking manual dexterity or mental abilities necessary to operate the pump
* General contraindications as uncorrectable bleeding tendency
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khaled Mohamed Hafez Morsy Almekaty, Msc

Role: PRINCIPAL_INVESTIGATOR

Urology Department- Tanta University

Samir Abdelhakim Elgamal, Prof

Role: PRINCIPAL_INVESTIGATOR

Urology Department- Tanta University

Suks Minhas, Prof

Role: PRINCIPAL_INVESTIGATOR

Professor of urology University College London Hospital(UCLH)London, UK

Locations

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Tanta university - faculty of medicine

Cairo, Elgharbia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, MD

Role: CONTACT

00201095159522

Facility Contacts

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Sherief Abdelsalam, lecturer

Role: primary

00201095159522

Other Identifiers

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Khaled Hafez

Identifier Type: -

Identifier Source: org_study_id

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