Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06121687
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-08
First Post:
2023-11-01
Brief Title:
Shaeers Vein Ligation-I Internal Pudendal Vein Sub-Gluteal Ligation For Veno Occlusive Erectile Dysfunction
Sponsor:
Kasr El Aini Hospital
Organization:
Kasr El Aini Hospital
Study Overview
Official Title:
Shaeers Vein Ligation - I Internal Pudendal Vein Sub-Gluteal Ligation For The Management of Veno Occlusive Erectile Dysfunction The Surgical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Shaeer-I
Brief Summary:
The goal of this interventional study is to evaluate a new surgical technique Shaeers Sub-Gluteal Internal Pudendal Vein Ligation SHAEER-I in patients with deep system veno-occlusive erectile dysfunction VOD
The main questions 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
The main questions 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 Shaeers 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 Shaeers 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 assessors 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
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 Shaeers 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 assessors 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None