Erectile DysfunctionPIIMPNCT05531877
Penile Implant Intraoperative Measurements Planning Chart
A study testing Penile Prosthesis Implantation in people with Erectile Dysfunction and Erectile Dysfunction Following Radical Prostatectomy, run by Cairo University at 2 sites in Egypt.
Trial summary
This is a chart of penile size measurements where penile length and width are recorded intra-operatively prior to penile prosthesis implantation to guide the surgeon to the correct and adequate post-operative penile size Read more about this study
- Who is it for?
- Ages 21 to 99 years, men only
- Conditions the study is for
- Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction With Diabetes Mellitus
- What is being tested?
- Penile Prosthesis Implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Aug 2020to 6 Oct 2022
- 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 21 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Erectile dysfunction not responding to medical treatment
Who cannot join
- Patients refusing penile prosthesis implantation as a treatment modality for their erectile dysfunction
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Adham ZAAZAA
Giza, 12578
Adham ZAAZAA, MD PhD MRCS, +201227427049, adhamzaazaa@gmail.com
- Recruiting
Adham ZAAZAA
Giza, الجيزة, 12578
Adham ZAAZAA, PhD, +201227427049, adhamzaazaa@gmail.com
Adham Zaazaa, PhD
About this study
This is a chart of penile size measurements where penile length and width are recorded intra-operatively prior to penile prosthesis implantation to guide the surgeon to the correct and adequate post-operative penile size
Read the detailed description
The chart records preoperative penile dimensions as penile length and circumference both relaxed and stretched, both in a de-tumescent and erect state, before after intra-operative injection of 1cc Prostaglandin E1 respectively, to enhance pharmacological tumescence.
The implantation of the penile implant will resume with the cavernosal sparing technique.
After the penile prosthesis has been implanted, penile length and girth will be measured and the penile implant dimensions will be recorded in the chart.
The PIMP chart will assist the surgeon in assuring he sized the penis most adequately with the implant by taking the penile dimensions ( Length and Circumference). To assure that the penis was not oversized with the implant, the post-operative penile length should not exceed the pre-operative penile tumescent stretched length.
To assure that the penis was not undersized, the postoperative penile length should not be less than the pre-operative tumescent non-stretched penile length..
The chart will also document the patients' penile dimensions pre and post operatively and could be used as an objective tool for post-operative patient counseling and reassurance about the results of the penile implant surgery.
- Conditions
- Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction With Diabetes Mellitus, Erectile Dysfunction Due to Arterial Disease, Erectile Dysfunction Due to Injury, Erectile Dysfunction Due to Neuropathy
- Being tested
- Penile Prosthesis Implantation
- Keywords
- Erectile Dysfunction, Penile Implant, Penile prosthesis
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penile Prosthesis ImplantationDiagnostic test
Penile measurement are taken preoperatively to serve as a guide to the surgeon to optimize post-operative penile size.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing Penile Implant Surgery | Experimental | All intraoperative measurements are documented in real time. Measurements recorded are as follows:
Preoperative Pre-ICI penile length and circumference, both in relaxed and stretched states. Preoperative post-ICI penile length and circumference, both in relaxed and stretched states. Postoperative penile length and circumference. Penile implant length and girth. Receives: Diagnostic Test: Penile Prosthesis Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
No oversizing
Post-operative Penile Length did not exceed pre-operative pharmacologically induced erect stretched length
Measured: Intraoperative
No undersizing
Post-operative penile length not less than pre-operative pharmacologically induced erect non-stretched penile length
Measured: Intraoperative
Secondary outcomes (1)
Adequate Girth
Post operative penile circumference not less than pre-operative pharmacologically induced erect stretched circumference
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Aug 2020
- Primary completion4 Sep 2022
- Study completion6 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The P.I.M.P Chart will be hung on the operative room wall and penile measurements pre and post operatively recorded as the surgery progresses together with the Penile Implant size.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adham ZAAZAA, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531877
- Sponsor's protocol ID
- PIIMP Chart
- Acronym
- PIIMP
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD shared within 1 year of publishing upon reasonable request
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 34257646Zaazaa A, Mostafa T. Spontaneous Penile Tumescence by Sparing Cavernous Tissue in the Course of Malleable Penile Prosthesis Implantation. J Sex Med. 2019 Mar;16(3):474-478. doi: 10.1016/j.jsxm.2019.01.012. Epub 2019 Feb 14.
PubMed 30773500
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penile Implant Intraoperative Measurements Planning Chart
- ClinicalTrials.gov ID
- NCT05531877
- Acronym / sponsor ID
- PIIMP / PIIMP Chart
- Conditions
- Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction With Diabetes Mellitus, Erectile Dysfunction Due to Arterial Disease, Erectile Dysfunction Due to Injury, Erectile Dysfunction Due to Neuropathy
- Keywords
- Erectile Dysfunction, Penile Implant, Penile prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 4 Sep 2022 (actual)
- Study completion
- 6 Oct 2022 (estimated)
- First posted
- 8 Sep 2022 (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.
This is a chart of penile size measurements where penile length and width are recorded intra-operatively prior to penile prosthesis implantation to guide the surgeon to the correct and adequate post-operative penile size
Detailed description
The chart records preoperative penile dimensions as penile length and circumference both relaxed and stretched, both in a de-tumescent and erect state, before after intra-operative injection of 1cc Prostaglandin E1 respectively, to enhance pharmacological tumescence.
The implantation of the penile implant will resume with the cavernosal sparing technique.
After the penile prosthesis has been implanted, penile length and girth will be measured and the penile implant dimensions will be recorded in the chart.
The PIMP chart will assist the surgeon in assuring he sized the penis most adequately with the implant by taking the penile dimensions ( Length and Circumference). To assure that the penis was not oversized with the implant, the post-operative penile length should not exceed the pre-operative penile tumescent stretched length.
To assure that the penis was not undersized, the postoperative penile length should not be less than the pre-operative tumescent non-stretched penile length..
The chart will also document the patients' penile dimensions pre and post operatively and could be used as an objective tool for post-operative patient counseling and reassurance about the results of the penile implant surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The P.I.M.P Chart will be hung on the operative room wall and penile measurements pre and post operatively recorded as the surgery progresses together with the Penile Implant size.
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Penile Implant Surgery | Experimental | Diagnostic Test: Penile Prosthesis ImplantationAll intraoperative measurements are documented in real time. Measurements recorded are as follows: Preoperative Pre-ICI penile length and circumference, both in relaxed and stretched states. Preoperative post-ICI penile length and circumference, both in relaxed and stretched states. Postoperative penile length and circumference. Penile implant length and girth. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Erectile dysfunction not responding to medical treatment
Key exclusion criteria (1 listed)
- Patients refusing penile prosthesis implantation as a treatment modality for their erectile dysfunction
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 |
|---|---|---|
| Penile Prosthesis ImplantationPenile measurement are taken preoperatively to serve as a guide to the surgeon to optimize post-operative penile size. | Diagnostic test | Patients undergoing Penile Implant Surgery |
Primary outcome
No oversizing
Time frame: Intraoperative
Post-operative Penile Length did not exceed pre-operative pharmacologically induced erect stretched length
No undersizing
Time frame: Intraoperative
Post-operative penile length not less than pre-operative pharmacologically induced erect non-stretched penile length
1 secondary outcome
Adequate Girth
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: 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.
- Background: PubMed 30773500Zaazaa A, Mostafa T. Spontaneous Penile Tumescence by Sparing Cavernous Tissue in the Course of Malleable Penile Prosthesis Implantation. J Sex Med. 2019 Mar;16(3):474-478. doi: 10.1016/j.jsxm.2019.01.012. Epub 2019 Feb 14.
- Individual participant dataSharing planned: Yes. IPD shared within 1 year of publishing upon reasonable request
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penile Prosthesis Implantation in people with Erectile Dysfunction and Erectile Dysfunction Following Radical Prostatectomy, run by Cairo University at 2 sites 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 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Adham Zaazaa (+201227427049, adhamzaazaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No oversizing (time frame: Intraoperative). The study lists 2 primary outcomes in all. 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 NCT05531877, which also lists 2 linked publications.
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 14 Sep 2022.