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Cavernous Tissue Preservation During Penile Prosthesis Implantation (CTP)

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Erectile Dysfunction

Treatments

Procedure: Intracavernosal injection of alprostadil
Procedure: Conventional penile prosthesis implantation
Procedure: Cavernous tissue sparing penile prosthesis implantation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Male

Ages

18 to 81 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Erectile dysfunction not amenable to treatment by approved medical therapy

Exclusion criteria

  • Erectile dysfunction amenable to treatment by approved medical therapy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Cavernous sparing group
Active Comparator group
Treatment:
Procedure: Intracavernosal injection of alprostadil
Procedure: Cavernous tissue sparing penile prosthesis implantation
Conventional technique group
Other group
Treatment:
Procedure: Conventional penile prosthesis implantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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