NCT03733860

Cavernous Tissue Preservation During Penile Prosthesis Implantation

Preservation of Penile Tumescence by Cavernous Tissue Preservation During Penile Prosthesis Implantation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Male
• Age: 18 Years – 81 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Cavernous tissue sparing penile prosthesis implantation	Beginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine.
PROCEDURE	Conventional penile prosthesis implantation	Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine
PROCEDURE	Intracavernosal injection of alprostadil	Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group

Timeline

• Start date: 2018-11-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2018-11-07
• Last updated: 2018-11-08

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study