Embolosclerotherapy Versus Deep Dorsal Vein Revascularization in Venogenic Erectile Dysfunction (venogenic ED)
Embolosclerotherapy Versus Deep Dorsal Vein Revascularization for Erectile Dysfunction Due to Venous Leak: A Randomized Clinical Study
調査の概要
状態
詳細な説明
Venous leak embolization performed following an intracavernosal injection of 20 µg alprostadil with the patient positioned supine. After spinal anesthesia, a deep dorsal penile vein punctured under ultrasound guidance using a stiff 20-G micropuncture set, a 0.018-inch guidewire, and a 4-French introducer.
The introducer advanced through Buck's fascia into the deep dorsal vein, carefully positioned near the radix penis, and a diagnostic venogram obtained to confirm the presence of venous leakage.
All instruments then flushed with 0.9% saline solution. Venous embolization carried out using a slow, controlled injection of a liquid embolic agent, either ethylene-vinyl alcohol copolymer (EVOH) in DMSO with tantalum powder or a polidocanol and gel foam mixture, under continuous fluoroscopic monitoring.
The injection stopped in time to prevent unintended spread of the embolic material to the internal pudendal or periprostatic veins leading to the iliohypogastric veins, the external pudendal veins leading to the femoral veins, or the dorsal penile veins.
Penile venous arterialization performed by creating an end-to-end anastomosis between the inferior epigastric artery and the deep dorsal penile vein. The procedure begin with an infrapubic incision, through which the superficial penile veins ligated. Buck's fascia then incised and opened along the midline. A sufficient segment of the dorsal penile vein carefully dissected, and all emissary and circumflex veins in the area ligated.
The inferior epigastric artery exposed via a pararectal incision. The vascular pedicle, including its venous components, dissected superiorly up to the umbilicus-where the artery was typically divided-and inferiorly toward its origin from the femoral artery within the pelvis. All arterial branches were secured during dissection. Approximately 15-20 cm of the vessel was mobilized to ensure adequate length to reach the deep dorsal vein.
The artery was then transected and redirected to the proximal penis through a small inguinal tunnel, and controlled using vascular clamps. Subsequently, the deep dorsal penile vein divided as proximally as possible in the infrapubic region, and its proximal end was ligated. An end-to-end anastomosis then performed between the distal end of the inferior epigastric artery and the distal segment of the deep dorsal vein using interrupted 7-0 monofilament nylon sutures under loupe magnification.
Heparinized solution was used to dilate both vessels during the anastomosis, while papaverine irrigation helped prevent arterial spasm.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Hassan A Hassan, MD
- 電話番号：+201116043210
- メール：hassan3ash1996@gmail.com
研究連絡先のバックアップ
- 名前：Mosaad A Soliman, MD, PhD
- 電話番号：+201001535711
- メール：soliman_mosaad@hotmail.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Cases with ED reporting difficulty in attaining or maintaining erection for at least 6 months.
- All participants were sexually active, in a stable and heterosexual partnership, living with their sexual partner for at least the past one year, and have only one sexual partner.
- The frequency of trying sexual intercourse was ≥1/week.
- Unsatisfactory response to PDE5i medication.
- All cases suffered venogenic erectile dysfunction diagnosed by color flow Doppler sonography before and after intracavernous injection of vasoactive drugs or Dynamic infusion cavernosometry-cavernosography (selected cases), which indicated veno-occlusive dysfunction.
Exclusion Criteria:
- Refusal to participate.
- Major psychological or psychiatric disorders.
- Non-vascular causes of ED including penile anatomic defects, any related neurological etiology or spinal cord injury, hypogonadism and hormonal disturbances.
- History of previous venous surgery, suspected or proven deep venous thrombosis, history of Deep Vein Thrombosis.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：endovascular emblosclerotherapy for venogenic erectile dysfunction
The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins.
|
The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins.
|
|
アクティブコンパレータ：Revascularization of Deep dorsal vein
Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery
|
Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
improvement in International Index of Erectile Function
時間枠：6 weeks
|
minimal clinically important difference, defined as a ≥4-point increase in the EF domain of the IIEF score
|
6 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
safety outcomes, including major adverse events classified according to the CIRSE classification system
時間枠：6 weeks
|
6 weeks
|
|
post-procedural pain assessed using a visual analogue scale
時間枠：6 weeks
|
6 weeks
|
|
patient-reported outcomes using the Patient Global Impression of Improvement
時間枠：6 weeks
|
6 weeks
|
協力者と研究者
捜査官
- 主任研究者：Mosaad A Soliman, MD, PhD、vascular surgery department, faculty of medicine, mansoura university
- スタディチェア：khaled A mowafy, MD, PhD、vascular surgery department, faculty of medicine, mansoura university
- スタディチェア：Reem M Soliman, MD, PhD、vascular surgery department, faculty of medicine, mansoura university
- スタディチェア：Ahmed Azhar, MD, PhD, FACS、vascular surgery department, faculty of medicine, mansoura university
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- R.26.04.3667
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。