Cavernous Tissue Preservation During Penile Prosthesis Implantation (CTP)
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|ClinicalTrials.gov Identifier: NCT03733860|
Recruitment Status : Active, not recruiting
First Posted : November 7, 2018
Last Update Posted : November 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Procedure: Cavernous tissue sparing penile prosthesis implantation Procedure: Conventional penile prosthesis implantation Procedure: Intracavernosal injection of alprostadil||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preservation of Penile Tumescence by Cavernous Tissue Preservation During Penile Prosthesis Implantation|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
|Active Comparator: Cavernous sparing group||
Procedure: Cavernous tissue sparing penile prosthesis implantation
Beginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine.
Procedure: Intracavernosal injection of alprostadil
Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group
|Conventional technique group||
Procedure: Conventional penile prosthesis implantation
Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine
- Cavernous tissue thickness postoperatively measured by ultrasound [ Time Frame: 1 month ]
- Presence of spontaneous penile tumescence post operatively [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733860
|Principal Investigator:||Adham Zaazaa, PhD||Cairo University|