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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Erectile Dysfunction; Erectile Dysfunction Due to Venous Disorder
• Intervention / Treatment: Procedure: Shaeer-II; Procedure: PPI

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Osama Shaeer, MD, PhD; Phone Number: 00201006600606; Email: osamashaeer@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Kasr El Aini Faculty of Medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.; Other Names: Shaeer's Vein Ligation - II; Internal Pudendal Vein Perineal Ligation
Active Comparator: PPI; Penile prosthesis implantation (PPI) will be performed	Procedure: PPI; Penile Prosthesis Implantation will be performed; Other Names: Penile Prosthesis Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Satisfaction Scale	A questionnaire to assess satisfaction with the results of surgery	6 months
Abbreviated International Index of Erectile Function	A questionnaire to assess erectile function	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Complications - if any - shall be recorded	6 months

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Study Chair: Osama Shaeer, MD,PhD, kasr El Aini Faculty of Medicine, Cairo University, Egypt

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: erectile dysfunction; veno-occlusive erectile dysfunction; venous leak; internal pudendal vein ligation
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: Shaeer's Vein Ligation-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No