Shaeer's Vein Ligation-II: Internal Pudendal Vein Perineal Ligation For Veno Occlusive Erectile Dysfunction

NCT ID: NCT06121674

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2025-02-28

Brief Summary

The goal of this interventional study is to evaluate a new surgical technique (Shaeer's Perineal Internal Pudendal Vein Ligation (SHAEER-II)) 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-II or PPI surgery
• Report the results of surgery for at least 6 months

Detailed Description

Title Shaeer's Vein Ligation - II: Internal Pudendal Vein Perineal Ligation For The Management of Veno Occlusive Erectile Dysfunction. The Surgical Study

Objectives Vein ligation surgery for veno-occlusive erectile dysfunction (VOD) has largely been unsuccessful, possibly due to the extensive collateral circulation, but also due to confinement to intermediate vein system ligation. The deep system of veins has been surgically inaccessible.

This is study evaluates Shaeer's Vein Ligation - II (Shaeer-II): a surgical technique for ligation of the deep system of veins; the internal pudendal vein.

Methods 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-II. Patients opting for PPI will be assigned to the PPI group. Patients opting to SHAEER-I will be assigned to (SHAEER-II group).

Primary outcome will be measured as per satisfaction rates and erectile function, at the 6th month post-operative. Evaluation shall be through the Treatment Satisfaction Scale (TSS) Scores and the Abbreviated International Index of Erectile Function (IIEF-5). Outcome assessor/s shall be blinded as to the patient group. Secondary outcome will be complications -if any.

Surgical Technique for SHAEER-II:

SHAEER-II targets ligation of the internal pudendal vein at the point where the vein exits Alcock's canal, and courses lateral to the ischial tuberosity.

Patient is oriented in the lithotomy position. The ischial tuberosity is marked. An incision is cut medial to the ischial tuberosity. Subcutaneous fat is dissected down to the neurovascular bundle harboring the internal pudendal vein. The vein is then ligated.

Pre-operative Evaluation:

• Patients will fill the IIEF-5 questionnaire
• Review of past-utilization of medical treatment for ED (erectile dysfunction)
• Laboratory Investigations: serum testosterone (free and total), prolactin, blood sugar profile, lipid profile, general pre-operative investigations.
• Imaging: penile duplex and cavernosography.

Conditions

Erectile Dysfunction; Erectile Dysfunction Due to Venous Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Shaeer-II

SHAEER-II targets ligation of the internal pudendal vein at the point where the vein exits Alcock's canal, and courses lateral to the ischial tuberosity.

Patient is oriented in the lithotomy position. The ischial tuberosity is marked. An incision is cut medial to the ischial tuberosity. Subcutaneous fat is dissected down to the neurovascular bundle harboring the internal pudendal vein. The vein is then ligated.

Group Type: EXPERIMENTAL

Shaeer-II

Intervention Type: PROCEDURE

SHAEER-I targets ligation of the internal pudendal vein at the point where the vein exits Alcock's canal, and courses lateral to the ischial tuberosity.

Patient is oriented in the lithotomy position. The ischial tuberosity is marked. An incision is cut medial to the ischial tuberosity. Subcutaneous fat is dissected down to the neurovascular bundle harboring the internal pudendal vein. The vein is then ligated.

PPI

Penile prosthesis implantation (PPI) will be performed

Group Type: ACTIVE_COMPARATOR

PPI

Intervention Type: PROCEDURE

Penile Prosthesis Implantation will be performed

Interventions

Shaeer-II

SHAEER-I targets ligation of the internal pudendal vein at the point where the vein exits Alcock's canal, and courses lateral to the ischial tuberosity.

Patient is oriented in the lithotomy position. The ischial tuberosity is marked. An incision is cut medial to the ischial tuberosity. Subcutaneous fat is dissected down to the neurovascular bundle harboring the internal pudendal vein. The vein is then ligated.

Intervention Type: PROCEDURE

PPI

Penile Prosthesis Implantation will be performed

Intervention Type: PROCEDURE

Other Intervention Names

Shaeer's Vein Ligation - II; Internal Pudendal Vein Perineal Ligation; Penile Prosthesis Implantation

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Osama Shaeer

Prof.Dr.Osama Shaeer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Osama Shaeer, MD,PhD

Role: STUDY_CHAIR

kasr El Aini Faculty of Medicine, Cairo University, Egypt

Locations

Kasr El Aini Faculty of Medicine, Cairo University

Cairo, , Egypt

Countries

Egypt

Central Contacts

Osama Shaeer, MD, PhD

Role: CONTACT

osamashaeer@gmail.com

00201006600606

Other Identifiers

Shaeer's Vein Ligation-II

Identifier Type: -

Identifier Source: org_study_id