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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06121687
Acronym
Shaeer-I
Enrollment
60
Registered
2023-11-08
Start date
2024-01-31
Completion date
2025-02-28
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

veno-occlusive erectile dysfunction, erectile dysfunction, venous leak

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.

Interventions

PROCEDUREShaeer-I

Ligation of the internal pudendal vein under the Gluteus Maximus muscle as it courses above the scar-spinous ligament.

PROCEDUREPPI

Penile prosthesis implantation (PPI) will be performed

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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).

Eligibility

Sex/Gender
MALE
Age
20 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment Satisfaction Scale6 monthsA questionnaire to assess satisfaction with the results of surgery
International Index of Erectile Function6 monthsA questionnaire to assess erectile function

Secondary

MeasureTime frameDescription
Complications6 monthsComplications - if any - shall be recorded

Countries

Egypt

Contacts

Primary ContactOsama Shaeer, MD, PhD
osamashaeer@gmail.com00201006600606

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026