Erectile Dysfunction
Conditions
Keywords
erectile dysfunction, penile tumescence, cavernous tissue
Brief summary
Spontaneous penile tumescence after penile prosthesis implantation has been previously reported as sporadically occurring during implant surgery. This study aims at systematically preserving residual erectile function, by the preservation of the patients' spontaneous penile tumescence by systematically sparing cavernous tissue during penile prosthesis implantation.
Detailed description
Patients undergoing the cavernous tissue sparing penile implant procedure will be injected intraoperatively with 40µg alprostadil, a prostaglandin E1 agonist intracorporal injection (ICI). The procedure will begin as soon as maximal tumescence is attained. In the cavernous sparing group, corporal dilation will be done solely with a size 8 dilator. The insertion of the dilator will be carefully inserted in what we call the path of least resistance. To determine the path of least resistance, the corporotomy is spread apart by pulling on previously set stay sutures. The path of least resistance is the plane with maximum outflow of blood from the intraoperatively pharmaceutically dilated and blood filled corpora cavernosa. This plane can also be anticipated with a preoperative penile duplex.
Interventions
PROCEDURECavernous tissue sparing penile prosthesis implantation
Beginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine.
PROCEDUREConventional penile prosthesis implantation
Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine
PROCEDUREIntracavernosal injection of alprostadil
Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 81 Years
Healthy volunteers
No
Inclusion criteria
* Erectile dysfunction not amenable to treatment by approved medical therapy
Exclusion criteria
* Erectile dysfunction amenable to treatment by approved medical therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cavernous tissue thickness postoperatively measured by ultrasound | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Presence of spontaneous penile tumescence post operatively | 1 month |
Countries
Egypt
Outcome results
None listed