CTP: Cavernous Tissue Preservation During Penile Prosthesis Implantation

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03733860
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Days): 30
• Patients Per Site Per Month: 101.5

Study Details

Study Description

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.

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	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Preservation of Penile Tumescence by Cavernous Tissue Preservation During Penile Prosthesis Implantation
• Actual Study Start Date: Nov 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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
Other: Conventional technique group	Procedure: Conventional penile prosthesis implantation; Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine

Outcome Measures

Primary Outcome Measures

1. Cavernous tissue thickness postoperatively measured by ultrasound [1 month]

Secondary Outcome Measures

1. Presence of spontaneous penile tumescence post operatively [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 81 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Erectile dysfunction not amenable to treatment by approved medical therapy

Exclusion Criteria:

• Erectile dysfunction amenable to treatment by approved medical therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Adham Zaazaa, PhD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adham Zaazaa, Assistant Lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT03733860
• Other Study ID Numbers: AZ2017
• First Posted: Nov 7, 2018
• Last Update Posted: Nov 8, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Adham Zaazaa, Assistant Lecturer, Cairo University: erectile dysfunction; penile tumescence; cavernous tissue
• Additional relevant MeSH terms: Erectile Dysfunction; Alprostadil

Study Results

No Results Posted as of Nov 8, 2018