Cavernous Tissue Preservation During Penile Prosthesis Implantation

Not Applicable

• Conditions: Erectile Dysfunction
• Interventions: Procedure: Cavernous tissue sparing penile prosthesis implantation; Procedure: Conventional penile prosthesis implantation; Procedure: Intracavernosal injection of alprostadil

• Registration Number: NCT03733860
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-11-01
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-07
• Last Update Submitted: 2018-11-07
• Last Update Posted: 2018-11-08
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Erectile dysfunction not amenable to treatment by approved medical therapy

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Exclusion Criteria

• Erectile dysfunction amenable to treatment by approved medical therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cavernous sparing group	Intracavernosal injection of alprostadil	-
Cavernous sparing group	Cavernous tissue sparing penile prosthesis implantation	-
Conventional technique group	Conventional penile prosthesis implantation	-

Primary Outcome Measures

Name	Time	Method
Cavernous tissue thickness postoperatively measured by ultrasound	1 month

Secondary Outcome Measures

Name	Time	Method
Presence of spontaneous penile tumescence post operatively	1 month

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt