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

NCT05558163 | Unknown DMC

• 1 other identifier: 61158m2
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Penile Prosthesis Infection; Penile Prosthesis; Complications, Infection or Inflammation

Keywords

erectyle dysfunction; penile prothesis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

PPI through traditional penoscrotal approach

OTHER

cases of erectyl dysfunction who underwent PPI throug penoscrotal approach

Procedure: penoscrotal approach for PPI

PPI through novel transverse scrotal approach

OTHER

cases of erectyl dysfunction who underwent PPI throug novel transverse scrotal approach

Procedure: transverse scrotal approach for PPI

Interventions

transverse scrotal approach for PPI PROCEDURE

penile prothesis implantation through penoscrotal approach outcome

PPI through novel transverse scrotal approach

penoscrotal approach for PPI PROCEDURE

penile prothesis implantation through penoscrotal approach outcome

PPI through traditional penoscrotal approach

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• male patients with active scrotal infection.
• contraindicaions to anasthesia.

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Conditions

Infections; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Model Details: 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 Record Dates

• First Submitted: September 25, 2022
• First Posted: September 28, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09