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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.
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:
Imaging:
Cardiopulmonary assessment
Post-operative evaluation:
Post-operative CBC.
Post-voiding residual urine volume.
(Qmax.) maximum flow rate.
Regular post-operative assessment of
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPI through traditional penoscrotal approach | Other | cases of erectyl dysfunction who underwent PPI throug penoscrotal approach |
|
| PPI through novel transverse scrotal approach | Other | cases of erectyl dysfunction who underwent PPI throug novel transverse scrotal approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transverse scrotal approach for PPI | Procedure | penile prothesis implantation through penoscrotal approach outcome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective cure rate | will be judged according to rate of wound healing, cosmotic final results, scar tension and scar pain. | 3 to 4 weaks |
| Objective cure rate | should include rate of complications as fistula, scar, extensive fibrosis, infection rate, incidence of prosthetic removal. | 4-12 weaks |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007239 | Infections |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| penoscrotal approach for PPI | Procedure | penile prothesis implantation through penoscrotal approach outcome |
|