Shaeer's Vein Ligation-I: Internal Pudendal Vein Sub-Gluteal Ligation For Veno Occlusive Erectile Dysfunction

NCT06121687 | Unknown

• 1 other identifier: Shaeer's Vein Ligation-I
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to evaluate a new surgical technique (Shaeer's Sub-Gluteal Internal Pudendal Vein Ligation (SHAEER-I)) in patients with deep system veno-occlusive erectile dysfunction (VOD) . The main question\[s\] it aims to answer are:

• \[Will the patients have satisfactory rigidity after surgery\]
• \[What will the Satisfaction rates be\]
• \[Will there be complications\] Participants will
• Undergo SHAEER-I or PPI surgery
• Report the results of surgery for at least 6 months

Conditions

Erectile Dysfunction

Keywords

veno-occlusive erectile dysfunction; erectile dysfunction; venous leak

Outcome Measures

Primary Outcomes (2)

• Treatment Satisfaction Scale

  A questionnaire to assess satisfaction with the results of surgery

  6 months

• International Index of Erectile Function

  A questionnaire to assess erectile function

  6 months

Secondary Outcomes (1)

• Complications

  6 months

Study Arms (2)

Shaeer-I

EXPERIMENTAL

Shaeer-I High Vein Ligation surgery will be performed. A hockey-stick or vertical incision encompassing the target point is cut, lateral to anal cleft. Subcutaneous fat is dissected down to the gluteus maximus, which is split along the direction of its fibers. The internal pudendal vein can be identified and ligated deep to the muscle, coursing between the pudendal nerve medially and the pudendal artery laterally.

Procedure: Shaeer-I

PPI

ACTIVE COMPARATOR

Penile prosthesis implantation (PPI) will be performed.

Procedure: PPI

Interventions

Shaeer-I PROCEDURE

Ligation of the internal pudendal vein under the Gluteus Maximus muscle as it courses above the scar-spinous ligament.

Also known as: Shaeer's Vein Ligation-I

Shaeer-I

PPI PROCEDURE

Penile prosthesis implantation (PPI) will be performed

Also known as: Penile Prosthesis Implantation

PPI

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients with deep system veno-occlusive erectile dysfunction
• Lack of response to medical treatment for erectile dysfunction including PDEi (Phosphodiesterase Inhibitors), aphrodisiacs, hormonal therapy (if there is a hormonal disturbance), and intracavernous injections, despite control of risk factors such as diabetes mellitus.

You may not qualify if:

• Patients with uncontrolled diabetes, smokers and patients with anesthesia risk
• Patients with arteriogenic erectile dysfunction, penile fibrosis, Peyronie's disease or psychiatric disorders.
• Patients with bilateral deep system VOD
• Patients who refuse to participate in the study

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Aini Faculty of Medicine, Cairo University

Cairo, 12311, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Penile Implantation

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Prosthesis Implantation; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Osama Shaeer, MD, PhD

  kasr El Aini Faculty of Medicine, Cairo University, Egypt

  STUDY CHAIR

Central Study Contacts

Osama Shaeer, MD, PhD

CONTACT

00201006600606; osamashaeer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: Surgery shall be performed for patients with VOD who are not responding to medical treatment and are candidate for penile prosthesis implantation. VOD will be documented by cavernosography to affect the deep system of veins; the internal pudendal vein, unilaterally. Patients will be randomized into two groups: one to proceed to Penile Prosthesis Implantation (PPI Group), and another to be offered a choice between PPI or SHAEER-I. Patients opting for PPI will be assigned to the PPI group. Patients opting to SHAEER-I will be assigned to (SHAEER-I group).

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 8, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)