Back to resultsCavernous Tissue Preservation During Penile Prosthesis Implantation (CTP)
Primary Purpose
Erectile Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cavernous tissue sparing penile prosthesis implantation
Conventional penile prosthesis implantation
Intracavernosal injection of alprostadil
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring erectile dysfunction, penile tumescence, cavernous tissue
Eligibility Criteria
Inclusion Criteria:
- Erectile dysfunction not amenable to treatment by approved medical therapy
Exclusion Criteria:
- Erectile dysfunction amenable to treatment by approved medical therapy
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Cavernous sparing group
Conventional technique group
Arm Description
Outcomes
Primary Outcome Measures
Cavernous tissue thickness postoperatively measured by ultrasound
Secondary Outcome Measures
Presence of spontaneous penile tumescence post operatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03733860
Brief Title
Cavernous Tissue Preservation During Penile Prosthesis Implantation
Acronym
CTP
Official Title
Preservation of Penile Tumescence by Cavernous Tissue Preservation During Penile Prosthesis Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
erectile dysfunction, penile tumescence, cavernous tissue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cavernous sparing group
Arm Type
Active Comparator
Arm Title
Conventional technique group
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Cavernous tissue sparing penile prosthesis implantation
Intervention Description
Beginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine.
Intervention Type
Procedure
Intervention Name(s)
Conventional penile prosthesis implantation
Intervention Description
Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine
Intervention Type
Procedure
Intervention Name(s)
Intracavernosal injection of alprostadil
Intervention Description
Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group
Primary Outcome Measure Information:
Title
Cavernous tissue thickness postoperatively measured by ultrasound
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Presence of spontaneous penile tumescence post operatively
Time Frame
1 month
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Erectile dysfunction not amenable to treatment by approved medical therapy
Exclusion Criteria:
Erectile dysfunction amenable to treatment by approved medical therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adham Zaazaa, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34257646
Citation
Zaazaa A, Bayerle-Eder M, Elnabarawy R, Elbitar M, Mostafa T. Penile Hemodynamic Response to Phosphodiesterase Type V Inhibitors after Cavernosal Sparing Inflatable Penile Prosthesis Implantation: A Prospective Randomized Open-Blinded End-Point (PROBE) Study. Adv Urol. 2021 Jun 28;2021:5548494. doi: 10.1155/2021/5548494. eCollection 2021.
Results Reference
derived
Learn more about this trial
Cavernous Tissue Preservation During Penile Prosthesis Implantation
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