NCT03466619RecruitingNot Applicable
Assessment of Safety and Efficacy of Inflatable Penile Prothesis in Patients With Erectile Dysfunction
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tanta University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Number of patients with improved erectile dysfunction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
inflatable penile prosthesis (IPP)
Experimental
inflatable penile prosthesis (IPP)
Intervention: inflatable penile prosthesis (IPP) (Device)
Outcomes
Primary Outcomes
Number of patients with improved erectile dysfunction
Time Frame: 3 years
The number of patients with improved erectile dysfunction
Secondary Outcomes
No secondary outcomes reported
Investigators
Sherief Abd-Elsalam
Investigator
Tanta University
Study Sites (1)
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