Erectile DysfunctionCTPNCT03733860
Cavernous Tissue Preservation During Penile Prosthesis Implantation
A study testing Cavernous tissue sparing penile prosthesis implantation, Conventional penile prosthesis implantation and Intracavernosal injection of alprostadil in people with Erectile Dysfunction, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 81 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Cavernous tissue sparing penile prosthesis implantation, Conventional penile prosthesis implantation and Intracavernosal injection of alprostadil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Erectile dysfunction not amenable to treatment by approved medical therapy
Who cannot join
- Erectile dysfunction amenable to treatment by approved medical therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preservation of Penile Tumescence by Cavernous Tissue Preservation During Penile Prosthesis Implantation
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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Cavernous tissue sparing penile prosthesis implantation, Conventional penile prosthesis implantation, Intracavernosal injection of alprostadil
- Keywords
- erectile dysfunction, penile tumescence, cavernous tissue
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cavernous tissue sparing penile prosthesis implantationProcedure or surgery
Beginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine.
Conventional penile prosthesis implantationProcedure or surgery
Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine
Intracavernosal injection of alprostadilProcedure or surgery
Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group
| Study group | Role | What they receive |
|---|---|---|
| Cavernous sparing group | Active comparator | Not described Receives: Procedure: Cavernous tissue sparing penile prosthesis implantation; Procedure: Intracavernosal injection of alprostadil |
| Conventional technique group | Other | Not described Receives: Procedure: Conventional penile prosthesis implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cavernous tissue thickness postoperatively measured by ultrasound
Measured: 1 month
Secondary outcomes (1)
Presence of spontaneous penile tumescence post operatively
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Nov 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adham Zaazaa, Cairo University
- Investigators
- Adham Zaazaa, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733860
- Sponsor's protocol ID
- AZ2017
- Acronym
- CTP
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34257646
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of Penile Tumescence by Cavernous Tissue Preservation During Penile Prosthesis Implantation
- ClinicalTrials.gov ID
- NCT03733860
- Acronym / sponsor ID
- CTP / AZ2017
- Conditions
- Erectile Dysfunction
- Keywords
- erectile dysfunction, penile tumescence, cavernous tissue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cavernous sparing group | Active comparator | Procedure: Cavernous tissue sparing penile prosthesis implantation, Procedure: Intracavernosal injection of alprostadil |
| Conventional technique group | Other | Procedure: Conventional penile prosthesis implantation |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Erectile dysfunction not amenable to treatment by approved medical therapy
Key exclusion criteria (1 listed)
- Erectile dysfunction amenable to treatment by approved medical therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cavernous tissue sparing penile prosthesis implantationBeginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine. | Procedure or surgery | Cavernous sparing group |
| Conventional penile prosthesis implantationBeginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine | Procedure or surgery | Conventional technique group |
| Intracavernosal injection of alprostadilIntraoperative intracavernosal injection of alprostadil in the cavernous sparing group | Procedure or surgery | Cavernous sparing group |
Primary outcome
Cavernous tissue thickness postoperatively measured by ultrasound
Time frame: 1 month
1 secondary outcome
Presence of spontaneous penile tumescence post operatively
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Derived from this study: PubMed 34257646Zaazaa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adham Zaazaa, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cavernous tissue sparing penile prosthesis implantation, Conventional penile prosthesis implantation and Intracavernosal injection of alprostadil in people with Erectile Dysfunction, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cavernous tissue thickness postoperatively measured by ultrasound (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03733860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.