Erectile DysfunctionShaeer-IINCT06121674
Shaeer's Vein Ligation-II: Internal Pudendal Vein Perineal Ligation For Veno Occlusive Erectile Dysfunction
A study testing Shaeer-II and PPI in people with Erectile Dysfunction and Erectile Dysfunction Due to Venous Disorder, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
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) . Read more about this study
- Who is it for?
- Ages 20 to 85 years, men only
- Conditions the study is for
- Erectile Dysfunction, Erectile Dysfunction Due to Venous Disorder
- What is being tested?
- Shaeer-II and PPI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- Shaeer-II, PPI
- Keywords
- veno-occlusive erectile dysfunction, erectile dysfunction, venous leak, internal pudendal vein ligation
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shaeer-IIProcedure or surgery
Also called Shaeer's Vein Ligation - II, Internal Pudendal Vein Perineal Ligation
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.
PPIProcedure or surgery
Also called Penile Prosthesis Implantation
Penile Prosthesis Implantation will be performed
| Study group | Role | What they receive |
|---|---|---|
| Shaeer-II | Experimental | 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. Receives: Procedure: Shaeer-II |
| PPI | Active comparator | Penile prosthesis implantation (PPI) will be performed Receives: Procedure: PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction Scale
A questionnaire to assess satisfaction with the results of surgery
Measured: 6 months
Abbreviated International Index of Erectile Function
A questionnaire to assess erectile function
Measured: 6 months
Secondary outcomes (1)
Complications
Complications - if any - shall be recorded
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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-II. Patients opting for PPI will be assigned to the PPI group. Patients opting to SHAEER-II will be assigned to (SHAEER-II group).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Shaeer, Kasr El Aini Hospital
- Investigators
- Osama Shaeer, MD,PhD, Study chair, kasr El Aini Faculty of Medicine, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121674
- Sponsor's protocol ID
- Shaeer's Vein Ligation-II
- Acronym
- Shaeer-II
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shaeer's Vein Ligation - II: Internal Pudendal Vein Perineal Ligation For The Management of Veno Occlusive Erectile Dysfunction. The Surgical Study
- ClinicalTrials.gov ID
- NCT06121674
- Acronym / sponsor ID
- Shaeer-II / Shaeer's Vein Ligation-II
- Keywords
- veno-occlusive erectile dysfunction, erectile dysfunction, venous leak, internal pudendal vein ligation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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-II. Patients opting for PPI will be assigned to the PPI group. Patients opting to SHAEER-II will be assigned to (SHAEER-II group).
| Arm | Type | Receives |
|---|---|---|
| Shaeer-II | Experimental | Procedure: Shaeer-IISHAEER-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. |
| PPI | Active comparator | Procedure: PPIPenile prosthesis implantation (PPI) will be performed |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shaeer-IIAlso: Shaeer's Vein Ligation - II, Internal Pudendal Vein Perineal LigationSHAEER-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. | Procedure or surgery | Shaeer-II |
| PPIAlso: Penile Prosthesis ImplantationPenile Prosthesis Implantation will be performed | Procedure or surgery | PPI |
Primary outcome
Treatment Satisfaction Scale
Time frame: 6 months
A questionnaire to assess satisfaction with the results of surgery
Abbreviated International Index of Erectile Function
Time frame: 6 months
A questionnaire to assess erectile function
1 secondary outcome
Complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama Shaeer, MD,PhD study chair
kasr El Aini Faculty of Medicine, Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shaeer-II and PPI in people with Erectile Dysfunction and Erectile Dysfunction Due to Venous Disorder, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osama Shaeer, MD, PhD (00201006600606, osamashaeer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Satisfaction Scale (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.