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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
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Penile Prosthesis Infection focused on measuring erectyle dysfunction, penile prothesis

Eligibility Criteria

30 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    September 25, 2022
    Last Updated
    September 25, 2022
    Sponsor
    Al-Azhar University
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    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

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    Minimally Invasive Scrotal Incision for Penile Prosthesis Implantation, Novel Technique.

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