MedPath

malleable penile prosthesis for treatment of erectile dysfunctio

Phase 4
Recruiting
Conditions
Urological and Genital Diseases
Registration Number
PACTR202206546247568
Lead Sponsor
eslam mohamed abdel wareth
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Male
Target Recruitment
50
Inclusion Criteria

•Sexually active male patients (20-70) years old.

•International index of erectile function (IIEF=1-16).

•Cardiac patients with contraindications for the use of PDE5Is

•Patients who need high doses of PDE5Is to achieve an erection.

•Advanced Peyronie’s Disease

•Priapism

•Following penile or pelvic trauma or surgery

Exclusion Criteria

•Active infection anywhere in the body, particularly urinary tract or genital infection
•Unresolved problems of urination such as elevated residual urine volume secondary to the neurogenic bladder or bladder outlet obstruction (BPE)
•Patients not willing to go for device revision surgery

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
efficacy of different techniques in the malleable penile prosthesis implantation, its effect on patient satisfaction, and predictors of success
Secondary Outcome Measures
NameTimeMethod
to detect complications and their pre and intra-operative predictors
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