Back to resultsPenile Prosthesis in Patients With Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
inflatable penile prosthesis (IPP)
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility 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
Sites / Locations
- Tanta university - faculty of medicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
inflatable penile prosthesis (IPP)
Arm Description
inflatable penile prosthesis (IPP)
Outcomes
Primary Outcome Measures
Number of patients with improved erectile dysfunction
The number of patients with improved erectile dysfunction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03466619
Brief Title
Penile Prosthesis in Patients With Erectile Dysfunction
Official Title
Assessment of Safety and Efficacy of Inflatable Penile Prothesis in Patients With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
December 1, 2027 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
inflatable penile prosthesis (IPP)
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
inflatable penile prosthesis (IPP)
Arm Type
Experimental
Arm Description
inflatable penile prosthesis (IPP)
Intervention Type
Device
Intervention Name(s)
inflatable penile prosthesis (IPP)
Other Intervention Name(s)
penile prosthesis (IPP)
Intervention Description
inflatable penile prosthesis (IPP)
Primary Outcome Measure Information:
Title
Number of patients with improved erectile dysfunction
Description
The number of patients with improved erectile dysfunction
Time Frame
3 years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, MD
Phone
00201095159522
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Mohamed Hafez Morsy Almekaty, Msc
Organizational Affiliation
Urology Department- Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samir Abdelhakim Elgamal, Prof
Organizational Affiliation
Urology Department- Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suks Minhas, Prof
Organizational Affiliation
Professor of urology University College London Hospital(UCLH)London, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta university - faculty of medicine
City
Cairo
State/Province
Elgharbia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abdelsalam, lecturer
Phone
00201095159522
Email
Sheriefabdelsalam@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Penile Prosthesis in Patients With Erectile Dysfunction
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