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

Erectile Dysfunction Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Erectile Dysfunction

• NCT number: NCT06121674
• Study type: Interventional
• Source: Kasr El Aini Hospital
• Contact: Osama Shaeer, MD, PhD
• Phone: 00201006600606
• Email: osamashaeer@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Completion date: February 2025