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Penile Prosthesis in Patients With Erectile Dysfunction

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03466619
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
157
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: inflatable penile prosthesis (IPP)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
inflatable penile prosthesis (IPP)inflatable penile prosthesis (IPP)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Assessment of Safety and Efficacy of Inflatable Penile Prothesis in Patients With Erectile Dysfunction
Actual Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: inflatable penile prosthesis (IPP)

inflatable penile prosthesis (IPP)

Device: inflatable penile prosthesis (IPP)
inflatable penile prosthesis (IPP)
Other Names:
  • penile prosthesis (IPP)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with improved erectile dysfunction [3 years]

      The number of patients with improved erectile dysfunction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta university - faculty of medicine Cairo Elgharbia Egypt

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, Investigator, Tanta University
    ClinicalTrials.gov Identifier:
    NCT03466619
    Other Study ID Numbers:
    • Khaled Hafez
    First Posted:
    Mar 15, 2018
    Last Update Posted:
    Mar 15, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of Mar 15, 2018