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

Erectile Dysfunction Clinical Trial

— Shaeer-I  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06121687
• Other study ID #: Shaeer's Vein Ligation-I
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: February 2025

Study information

• Verified date: November 2023
• Source: Kasr El Aini Hospital
• Contact: Osama Shaeer, MD, PhD
• Phone: 00201006600606
• Email: osamashaeer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Title Shaeer's Vein Ligation - I: Internal Pudendal Vein Sub-Gluteal 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 - I (Shaeer-I): the first 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-I. Patients opting for PPI will be assigned to the PPI group. Patients opting to SHAEER-I will be assigned to (SHAEER-I 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-I:

SHAEER-I targets ligation of the internal pudendal vein at the point where the vein exits the lesser sciatic foramen, courses superficial to the sacrospinous ligament then dips into the greater sciatic foramen, under the gluteus maximus muscle.

Surface anatomical landmarks are used to identify the ischial spine, at the intersection between two lines: a vertical line bridging the posterior superior iliac spine to the ischial tuberosity, and a horizontal one extending from the sacro-coccygeal joint, laterally. The internal pudendal vein emerges and dips lateral to the ischial spine.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Procedure:
• Shaeer-I
Ligation of the internal pudendal vein under the Gluteus Maximus muscle as it courses above the scar-spinous ligament.
• PPI
Penile prosthesis implantation (PPI) will be performed

Locations

Country	Name	City	State
Egypt	Kasr El Aini Faculty of Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Satisfaction Scale	A questionnaire to assess satisfaction with the results of surgery	6 months
Primary	International Index of Erectile Function	A questionnaire to assess erectile function	6 months
Secondary	Complications	Complications - if any - shall be recorded	6 months