Penile Prosthesis InfectionPPINCT05558163
Minimally Invasive Scrotal Incision for Penile Prosthesis Implantation, Novel Technique.
A study testing transverse scrotal approach for PPI and penoscrotal approach for PPI in people with Penile Prosthesis Infection and Penile Prosthesis; Complications, Infection or Inflammation, run by Al-Azhar University.
Trial summary
The main goals of this study are to examine the superiority of this novel technique and its acceptance by patients with ED candidate for PPI and compare these results with data available in the literature for ordinary peno-scrotal incision. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men only
- Conditions the study is for
- Penile Prosthesis Infection, Penile Prosthesis; Complications, Infection or Inflammation
- What is being tested?
- transverse scrotal approach for PPI and penoscrotal approach for PPI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 Dec 2023
- 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 30 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- The study participants are male patients who are candidate for penile prosthesis implantation and will accept to do minimal scrotal incision procedure for treatment of ED.
Who cannot join
- male patients with active scrotal infection.
- contraindicaions to anasthesia.
About this study
The main goals of this study are to examine the superiority of this novel technique and its acceptance by patients with ED candidate for PPI and compare these results with data available in the literature for ordinary peno-scrotal incision.
Read the detailed description
Rational for the expected superiority of scrotal approach over peno-scrotal approach in penile prosthesis implant (PPI):
A- Expected to have all the previously mentioned pros of the traditional approach.
B- Expected lower incidence of post-operative pain with our novel approach owing to lower sensitivity of scrotal skin and tension free wound closure compared to traditional peno-scrotal approach.
C- Expected lower incidence of infection owing to multilevel wound closure done in our novel approach.
D- Expected rapid wound closure and wound healing than traditional peno-scrotal approach owing to difference in embryologic origin of penile and scrotal skin.
E- Validity of this novel approach for malleable and inflatable prosthesis implantation.
F- Short learning curve owing to simplicity of the approach even for junior urologists.
3- Research methodology
- Responsible party: drmohamedalgammal@gmail.com Study Type: Interventional study Sampling: Hospital-based sample Estimated Enrollment: 200 participants Intervention Model: Patients who will undergo scrotal approach will be compared with a case-matched of patients who underwent PPI through peno-scrotal approach in our institution during the last 5 years.
Study Start Date: 2022
Estimated Study Completion Date: 2023
Study Location:
Al-Hussin and Sayed Galal, Al-Azhar University Hospital, Cairo, Egypt.
Study Population:
- The study participants are male patients who are candidate for penile prosthesis implantation and will accept to do minimal scrotal incision procedure for treatment of ED.
Study Sample:
- All available cases with complete medical record and accepted follow-up with us will be included.
Pre-Operative Evaluation
- Full medical history taking including full sexual history and (IIEF5) table 1.
- Physical Examination including general, abdominal and local genital examination.
- Laboratory investigations:
- Complete urine analysis and urine culture
- Blood chemistry tests include blood urea, serum creatinine, liver function tests, blood sugar, and coagulation profile.
- Lipid profile.
- Hormonal assessment including serum testosterone, Follicular stimulating hormone (FSH) Luteinizing hormone (LH) and prolactin.
- Complete blood cell count (CBC).
- Psychosexual assessment if needed.
- Imaging:
- Penile douplex Ultra-sonography.
- Nocturnal penile tumescence and rigidity study, (NPTR or Rigiscan) if needed.
- Abdomino-pelvic ultra-sonography with residual urine calculation.
- Uroflowmetry if needed.
- Cardiopulmonary assessment
Post-operative evaluation:
- Post-operative CBC.
- Post-voiding residual urine volume.
- (Qmax.) maximum flow rate.
- Regular post-operative assessment of
- Pain using Numeric Pain Rating Scale (NRS)
- Wound healing, cosmetic appearance after healing and any incidence of infection.
- Incidence of satisfaction after regaining sexual activity using SSI.
- Being tested
- transverse scrotal approach for PPI, penoscrotal approach for PPI
- Keywords
- erectyle dysfunction, penile prothesis
- Medical subject headings
- Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transverse scrotal approach for PPIProcedure or surgery
penile prothesis implantation through penoscrotal approach outcome
penoscrotal approach for PPIProcedure or surgery
penile prothesis implantation through penoscrotal approach outcome
| Study group | Role | What they receive |
|---|---|---|
| PPI through traditional penoscrotal approach | Other | cases of erectyl dysfunction who underwent PPI throug penoscrotal approach Receives: Procedure: penoscrotal approach for PPI |
| PPI through novel transverse scrotal approach | Other | cases of erectyl dysfunction who underwent PPI throug novel transverse scrotal approach Receives: Procedure: transverse scrotal approach for PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective cure rate
will be judged according to rate of wound healing, cosmotic final results, scar tension and scar pain.
Measured: 3 to 4 weaks
Objective cure rate
should include rate of complications as fistula, scar, extensive fibrosis, infection rate, incidence of prosthetic removal.
Measured: 4-12 weaks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile Prosthesis InfectionStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients who will undergo scrotal approach will be compared with a case-matched of patients who underwent PPI through peno-scrotal approach in our institution during the last 5 years.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Almetwally Algammal,MD, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558163
- Sponsor's protocol ID
- 61158m2
- Acronym
- PPI
- Status last verified
- Sep 2022
- First submitted
- 25 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Scrotal Incision for Penile Prosthesis Implantation, Novel Technique.
- ClinicalTrials.gov ID
- NCT05558163
- Acronym / sponsor ID
- PPI / 61158m2
- Keywords
- erectyle dysfunction, penile prothesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 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.
The main goals of this study are to examine the superiority of this novel technique and its acceptance by patients with ED candidate for PPI and compare these results with data available in the literature for ordinary peno-scrotal incision.
Detailed description
Rational for the expected superiority of scrotal approach over peno-scrotal approach in penile prosthesis implant (PPI):
A- Expected to have all the previously mentioned pros of the traditional approach.
B- Expected lower incidence of post-operative pain with our novel approach owing to lower sensitivity of scrotal skin and tension free wound closure compared to traditional peno-scrotal approach.
C- Expected lower incidence of infection owing to multilevel wound closure done in our novel approach.
D- Expected rapid wound closure and wound healing than traditional peno-scrotal approach owing to difference in embryologic origin of penile and scrotal skin.
E- Validity of this novel approach for malleable and inflatable prosthesis implantation.
F- Short learning curve owing to simplicity of the approach even for junior urologists.
3- Research methodology
- Responsible party: drmohamedalgammal@gmail.com Study Type: Interventional study Sampling: Hospital-based sample Estimated Enrollment: 200 participants Intervention Model: Patients who will undergo scrotal approach will be compared with a case-matched of patients who underwent PPI through peno-scrotal approach in our institution during the last 5 years.
Study Start Date: 2022
Estimated Study Completion Date: 2023
Study Location:
Al-Hussin and Sayed Galal, Al-Azhar University Hospital, Cairo, Egypt.
Study Population:
- The study participants are male patients who are candidate for penile prosthesis implantation and will accept to do minimal scrotal incision procedure for treatment of ED.
Study Sample:
- All available cases with complete medical record and accepted follow-up with us will be included.
Pre-Operative Evaluation
- Full medical history taking including full sexual history and (IIEF5) table 1.
- Physical Examination including general, abdominal and local genital examination.
- Laboratory investigations:
- Complete urine analysis and urine culture
- Blood chemistry tests include blood urea, serum creatinine, liver function tests, blood sugar, and coagulation profile.
- Lipid profile.
- Hormonal assessment including serum testosterone, Follicular stimulating hormone (FSH) Luteinizing hormone (LH) and prolactin.
- Complete blood cell count (CBC).
- Psychosexual assessment if needed.
- Imaging:
- Penile douplex Ultra-sonography.
- Nocturnal penile tumescence and rigidity study, (NPTR or Rigiscan) if needed.
- Abdomino-pelvic ultra-sonography with residual urine calculation.
- Uroflowmetry if needed.
- Cardiopulmonary assessment
Post-operative evaluation:
- Post-operative CBC.
- Post-voiding residual urine volume.
- (Qmax.) maximum flow rate.
- Regular post-operative assessment of
- Pain using Numeric Pain Rating Scale (NRS)
- Wound healing, cosmetic appearance after healing and any incidence of infection.
- Incidence of satisfaction after regaining sexual activity using SSI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients who will undergo scrotal approach will be compared with a case-matched of patients who underwent PPI through peno-scrotal approach in our institution during the last 5 years.
| Arm | Type | Receives |
|---|---|---|
| PPI through traditional penoscrotal approach | Other | Procedure: penoscrotal approach for PPIcases of erectyl dysfunction who underwent PPI throug penoscrotal approach |
| PPI through novel transverse scrotal approach | Other | Procedure: transverse scrotal approach for PPIcases of erectyl dysfunction who underwent PPI throug novel transverse scrotal approach |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study participants are male patients who are candidate for penile prosthesis implantation and will accept to do minimal scrotal incision procedure for treatment of ED.
Key exclusion criteria (2 listed)
- male patients with active scrotal infection.
- contraindicaions to anasthesia.
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 |
|---|---|---|
| transverse scrotal approach for PPIpenile prothesis implantation through penoscrotal approach outcome | Procedure or surgery | PPI through novel transverse scrotal approach |
| penoscrotal approach for PPIpenile prothesis implantation through penoscrotal approach outcome | Procedure or surgery | PPI through traditional penoscrotal approach |
Primary outcome
Subjective cure rate
Time frame: 3 to 4 weaks
will be judged according to rate of wound healing, cosmotic final results, scar tension and scar pain.
Objective cure rate
Time frame: 4-12 weaks
should include rate of complications as fistula, scar, extensive fibrosis, infection rate, incidence of prosthetic removal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transverse scrotal approach for PPI and penoscrotal approach for PPI in people with Penile Prosthesis Infection and Penile Prosthesis; Complications, Infection or Inflammation, run by Al-Azhar University.
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 2 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Subjective cure rate (time frame: 3 to 4 weaks). 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?
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 28 Sep 2022.