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NCT03733860 Clinical Trial

Cavernous Tissue Preservation During Penile Prosthesis Implantation

Erectile Dysfunction Clinical Trial

— CTP  

Official title:
Preservation of Penile Tumescence by Cavernous Tissue Preservation During Penile Prosthesis Implantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03733860
Other study ID # AZ2017
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date December 2018

Study information
Verified date November 2018
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 81 Years
Eligibility Inclusion Criteria:

- Erectile dysfunction not amenable to treatment by approved medical therapy

Exclusion Criteria:

- Erectile dysfunction amenable to treatment by approved medical therapy

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cavernous tissue thickness postoperatively measured by ultrasound 1 month
Secondary Presence of spontaneous penile tumescence post operatively 1 month
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