Cavernous Tissue Preservation During Penile Prosthesis Implantation
CTP
Preservation of Penile Tumescence by Cavernous Tissue Preservation During Penile Prosthesis Implantation
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 6, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 8, 2018
November 1, 2018
1 month
November 6, 2018
November 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cavernous tissue thickness postoperatively measured by ultrasound
1 month
Secondary Outcomes (1)
Presence of spontaneous penile tumescence post operatively
1 month
Study Arms (2)
Cavernous sparing group
ACTIVE COMPARATORConventional technique group
OTHERInterventions
Beginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine.
Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine
Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group
Eligibility Criteria
You may qualify if:
- Erectile dysfunction not amenable to treatment by approved medical therapy
You may not qualify if:
- Erectile dysfunction amenable to treatment by approved medical therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
Related Publications (1)
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.
PMID: 34257646DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adham Zaazaa, PhD
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
November 6, 2018
First Posted
November 7, 2018
Study Start
November 1, 2018
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
November 8, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share