Clinical trial NCT06121687: Shaeer's Vein Ligation-I: Internal Pudendal Vein Sub-Gluteal Ligation For Veno Occlusive Erectile Dysfunction
Official title: Shaeer's Vein Ligation - I: Internal Pudendal Vein Sub-Gluteal Ligation For The Management of Veno Occlusive Erectile Dysfunction. The Surgical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Keywords: veno-occlusive erectile dysfunction
erectile dysfunction
venous leak
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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

Detailed 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.

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

Primary outcomes:
measure: Treatment Satisfaction Scale
timeFrame: 6 months
measure: International Index of Erectile Function
timeFrame: 6 months
Secondary outcomes:
measure: Complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Aini Faculty of Medicine, Cairo University
Study officials:
affiliation: kasr El Aini Faculty of Medicine, Cairo University, Egypt
name: Osama Shaeer, MD, PhD
role: STUDY_CHAIR
References: