Cavernous Tissue Preservation During Penile Prosthesis Implantation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Procedure: Cavernous tissue sparing penile prosthesis implantation
* Procedure: Conventional penile prosthesis implantation
* Procedure: Intracavernosal injection of alprostadil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Erectile dysfunction not amenable to treatment by approved medical therapy Exclusion Criteria: Erectile dysfunction amenable to treatment by approved medical therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cavernous sparing group<br> | Procedure: Cavernous tissue sparing penile prosthesis implantation<br>* Beginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine.<br>Procedure: Intracavernosal injection of alprostadil<br>* Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group<br>|
| Other: Conventional technique group<br> | Procedure: Conventional penile prosthesis implantation<br>* Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cavernous tissue thickness postoperatively measured by ultrasound |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of spontaneous penile tumescence post operatively |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erectile dysfunction, penile tumescence, cavernous tissue