Minimally Invasive Scrotal Incision for Penile Prosthesis Implantation, Novel Technique. (PPI)
Primary Purpose
Penile Prosthesis Infection, Penile Prosthesis; Complications, Infection or Inflammation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transverse scrotal approach for PPI
penoscrotal approach for PPI
Sponsored by
About this trial
This is an interventional treatment trial for Penile Prosthesis Infection focused on measuring erectyle dysfunction, penile prothesis
Eligibility Criteria
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:
- male patients with active scrotal infection.
- contraindicaions to anasthesia.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
PPI through traditional penoscrotal approach
PPI through novel transverse scrotal approach
Arm Description
cases of erectyl dysfunction who underwent PPI throug penoscrotal approach
cases of erectyl dysfunction who underwent PPI throug novel transverse scrotal approach
Outcomes
Primary Outcome Measures
Subjective cure rate
will be judged according to rate of wound healing, cosmotic final results, scar tension and scar pain.
Objective cure rate
should include rate of complications as fistula, scar, extensive fibrosis, infection rate, incidence of prosthetic removal.
Secondary Outcome Measures
Full Information
NCT ID
NCT05558163
First Posted
September 25, 2022
Last Updated
September 25, 2022
Sponsor
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT05558163
Brief Title
Minimally Invasive Scrotal Incision for Penile Prosthesis Implantation, Novel Technique.
Acronym
PPI
Official Title
Minimally Invasive Scrotal Incision for Penile Prosthesis Implantation, Novel Technique.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penile Prosthesis Infection, Penile Prosthesis; Complications, Infection or Inflammation
Keywords
erectyle dysfunction, penile prothesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PPI through traditional penoscrotal approach
Arm Type
Other
Arm Description
cases of erectyl dysfunction who underwent PPI throug penoscrotal approach
Arm Title
PPI through novel transverse scrotal approach
Arm Type
Other
Arm Description
cases of erectyl dysfunction who underwent PPI throug novel transverse scrotal approach
Intervention Type
Procedure
Intervention Name(s)
transverse scrotal approach for PPI
Intervention Description
penile prothesis implantation through penoscrotal approach outcome
Intervention Type
Procedure
Intervention Name(s)
penoscrotal approach for PPI
Intervention Description
penile prothesis implantation through penoscrotal approach outcome
Primary Outcome Measure Information:
Title
Subjective cure rate
Description
will be judged according to rate of wound healing, cosmotic final results, scar tension and scar pain.
Time Frame
3 to 4 weaks
Title
Objective cure rate
Description
should include rate of complications as fistula, scar, extensive fibrosis, infection rate, incidence of prosthetic removal.
Time Frame
4-12 weaks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
male patients with active scrotal infection.
contraindicaions to anasthesia.
12. IPD Sharing Statement
Learn more about this trial
Minimally Invasive Scrotal Incision for Penile Prosthesis Implantation, Novel Technique.
We'll reach out to this number within 24 hrs