Clinical trial NCT05558163: Minimally Invasive Scrotal Incision for Penile Prosthesis Implantation, Novel Technique.
Official title: Minimally Invasive Scrotal Incision for Penile Prosthesis Implantation, Novel Technique.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Penile Prosthesis Infection
Penile Prosthesis; Complications, Infection or Inflammation
Keywords: erectyle dysfunction
penile prothesis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 200
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

1. Full medical history taking including full sexual history and (IIEF5) table 1.
2. Physical Examination including general, abdominal and local genital examination.
3. Laboratory investigations:

   1. Complete urine analysis and urine culture
   2. Blood chemistry tests include blood urea, serum creatinine, liver function tests, blood sugar, and coagulation profile.
   3. Lipid profile.
   4. Hormonal assessment including serum testosterone, Follicular stimulating hormone (FSH) Luteinizing hormone (LH) and prolactin.
   5. Complete blood cell count (CBC).
   6. Psychosexual assessment if needed.
4. Imaging:

   1. Penile douplex Ultra-sonography.
   2. Nocturnal penile tumescence and rigidity study, (NPTR or Rigiscan) if needed.
   3. Abdomino-pelvic ultra-sonography with residual urine calculation.
   4. Uroflowmetry if needed.
5. Cardiopulmonary assessment

Post-operative evaluation:

* Post-operative CBC.
* Post-voiding residual urine volume.
* (Qmax.) maximum flow rate.
* Regular post-operative assessment of

  1. Pain using Numeric Pain Rating Scale (NRS)
  2. Wound healing, cosmetic appearance after healing and any incidence of infection.
  3. Incidence of satisfaction after regaining sexual activity using SSI.

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.

Primary outcomes:
measure: Subjective cure rate
timeFrame: 3 to 4 weaks
measure: Objective cure rate
timeFrame: 4-12 weaks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: