Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 495 for:    penis

Penile Prosthesis in Patients With Erectile Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03466619
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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
Erectile Dysfunction Device: inflatable penile prosthesis (IPP) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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 : November 1, 2014
Estimated Primary Completion Date : December 1, 2027
Estimated Study Completion Date : December 1, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: inflatable penile prosthesis (IPP)
inflatable penile prosthesis (IPP)
Device: inflatable penile prosthesis (IPP)
inflatable penile prosthesis (IPP)
Other Name: penile prosthesis (IPP)




Primary Outcome Measures :
  1. Number of patients with improved erectile dysfunction [ Time Frame: 3 years ]
    The number of patients with improved erectile dysfunction



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466619


Contacts
Layout table for location contacts
Contact: Sherief Abd-Elsalam, MD 00201095159522 sheriefabdelsalam@yahoo.com

Locations
Layout table for location information
Egypt
Tanta university - faculty of medicine Recruiting
Cairo, Elgharbia, Egypt
Contact: Sherief Abdelsalam, lecturer    00201095159522    Sheriefabdelsalam@yahoo.com   
Sponsors and Collaborators
Tanta University
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Sherief Abd-Elsalam, Investigator, Tanta University
ClinicalTrials.gov Identifier: NCT03466619     History of Changes
Other Study ID Numbers: Khaled Hafez
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders