Hydrodissection-Assisted Bipolar Prostatic Enucleation Versus Conventional Bipolar Enucleation

Официальное название

Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection With Subcapsular Injection of Diluted Norepinephrine-Methylene Blue Mixture Versus Conventional Bipolar Prostatic Enucleation-Enucleoresection: A Prospective Randomized Comparative Study

Обзор

This prospective randomized study will compare two surgical techniques for treating benign prostatic hyperplasia. Participants will be assigned to either hydrodissection-assisted bipolar prostatic enucleation-enucleoresection with transrectal ultrasound-guided subcapsular injection of diluted norepinephrine and methylene blue or conventional bipolar prostatic enucleation-enucleoresection without injection. The injected mixture is intended to separate the enlarged prostatic tissue from the surgical capsule and reduce bleeding during surgery. The study will evaluate whether the hydrodissection-assisted technique improves operative conditions, surgical outcomes, postoperative recovery, urinary symptoms, and urinary flow compared with the conventional technique.

Вмешательства

• Процедура Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection
  Transrectal ultrasound-guided subcapsular injection will be used to create a hydrodissection plane between the prostatic adenoma and capsule before bipolar enucleation-enucleoresection.
• Процедура Conventional Bipolar Prostatic Enucleation-Enucleoresection
  Participants will undergo conventional bipolar prostatic enucleation-enucleoresection without subcapsular injection or hydrodissection.

Первичные конечные точки

• Intraoperative Blood Loss [Срок оценки: Intraoperatively]

Вторичные конечные точки (9)

• Operative Time [Срок оценки: Intraoperatively]
• Enucleated Prostatic Tissue Weight [Срок оценки: Immediately after tissue retrieval, intraoperatively]
• Length of Hospital Stay [Срок оценки: From completion of surgery until hospital discharge, assessed up to 7 days]
• Urethral Catheterization Duration [Срок оценки: From completion of surgery until catheter removal, assessed up to 7 days]
• Change in Maximum Urinary Flow Rate [Срок оценки: At baseline and at 1, 3, and 6 months after surgery]
• Change in Post-Void Residual Urine Volume [Срок оценки: At baseline and at 1, 3, and 6 months after surgery]
• Change in International Prostate Symptom Score [Срок оценки: At baseline and at 1, 3, and 6 months after surgery]
• Incidence of Postoperative Complications [Срок оценки: At 1, 3, and 6 months after surgery]
• Incidence of Intraoperative Complications [Срок оценки: Intraoperatively]

Критерии участия

Критерии включения

• Benign prostatic hyperplasia.
• Prostate volume greater than 60 cc as measured by transrectal ultrasonography.
• Moderate-to-severe lower urinary tract symptoms, defined as an International Prostate - Symptom Score of 12 or higher.
• Failure of or poor response to medical management.

Критерии исключения

• History of prostate cancer or suspicious findings on prostate biopsy.
• Active urinary tract infection.
• Severe cardiovascular, pulmonary, or other systemic comorbidities that contraindicate surgery.
• Previous prostate surgery, including transurethral resection of the prostate or open prostatectomy.
• Chronic urinary retention associated with neurogenic bladder. Hypersensitivity to norepinephrine or methylene blue.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Benha University Hospital — Banhā

Идентификаторы

NCT: NCT07749794 · RC.8.1.2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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