Penile Prosthesis in Patients With Erectile Dysfunction

March 14, 2018 updated by: Sherief Abd-Elsalam, Tanta University

Assessment of Safety and Efficacy of Inflatable Penile Prothesis in Patients With Erectile Dysfunction

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elgharbia
      • Cairo, Elgharbia, Egypt
        • Recruiting
        • Tanta university - faculty of medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: inflatable penile prosthesis (IPP)
Device: inflatable penile prosthesis (IPP)
inflatable penile prosthesis (IPP)
Other Names:
  • penile prosthesis (IPP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with improved erectile dysfunction
Time Frame: 3 years
The number of patients with improved erectile dysfunction
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Khaled Mohamed Hafez Morsy Almekaty, Msc, Urology Department- Tanta University
  • Principal Investigator: Samir Abdelhakim Elgamal, Prof, Urology Department- Tanta University
  • Principal Investigator: Suks Minhas, Prof, Professor of urology University College London Hospital(UCLH)London, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Anticipated)

December 1, 2027

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Khaled Hafez

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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