Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction

Обзор

It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO). It has been considered for decades to be an inevitable consequence of restoring micturition comfort. EjD can have a substantial deleterious effect on the QoL of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. A better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. Our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.

Подробное описание

The aim of this study is To compare the efficacy of partial trans urethral resection of the prostate versus conventional resection of the prostate in improvement of lower urinary tract symptoms related to benign prostatic hyperplasia at 6 months. The secondary objectives are to compare the impacts of partial prostatic endoscopic surgery versus conventional endoscopic surgery on ejaculatory function, lower urinary tract symptoms, Global sexual life, Urinary flow, complication related to the surgery and the rates of re-treatment.

Investigators use a non-inferiority comparative single blinded (patient) multicenter randomized clinical trial in two parallel groups (Conventional endoscopic prostatic surgery Vs Partial surgery preserving the prostatic apex.

Вмешательства

• Процедура Partial surgery preserving the prostatic apex
  Partial Endoscopic resection of prostate to conserve apex
• Процедура Conventional endoscopic prostatic surgery
  Endoscopic resection of prostate.

Первичные конечные точки

• Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months [Срок оценки: 6 months after surgery]

Вторичные конечные точки (8)

• Evaluation of ejaculation and global sexual life [Срок оценки: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
• Evaluation of lower urinary tract symptoms [Срок оценки: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
• Evaluation of complication rates [Срок оценки: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
• Evaluation of ejaculation and global sexual life [Срок оценки: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
• Evaluation of ejaculation and global sexual life [Срок оценки: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
• Evaluation of lower urinary tract symptoms [Срок оценки: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
• Evaluation of lower urinary tract symptoms [Срок оценки: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]
• Evaluation of complication rates [Срок оценки: 1 month, 3 months, 6 months,12 months, and 36 months after surgery]

Критерии участия

Критерии включения

• Man over 40 years old
• Indication of surgical management for BPH
• Prostate volume ≥30 cc and ≤150 cc as evaluated by ultrasonography ( or an MRI if available)
• IPSS score ≥12
• Qmax ≤15 ml/s
• Affiliated to French national social security system
• wish and be able to comply with planned visits
• Able to express his consent
• Signed informed consent form

Критерии исключения

• Unwillingness to accept the treatment
• No pre-operative ejaculation or sexuality
• Neurological pathology responsible for micturition disorders
• History of prostatic surgery
• Stenosis of the urethra symptomatic
• History of prostate cancer
• History of radiotherapy or pelvic surgery
• Patient refusing the principle of partial surgery
• Life expectancy <3 years
• Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks.
• Participation in another clinical study involving an investigational product within 1 month before study entry.

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

Простое слепое

Основная цель

Другое

Центры проведения

Франция · 17 центров

• CH Pays d'Aix — Aix-en-Provence
• CHU Angers — Angers
• Centre Hospitalier Universitaire de Bordeaux — Bordeaux
• CHU Mondor — Créteil
• Hôpital Claude Huriez — Lille
• CHU de Limoges — Limoges
• Hôpital Nord Marseille — Marseille
• Polyclinique Saint George — Nice
• … и ещё 9 центров

Идентификаторы

NCT: NCT05574244 · CHUBX 2019/57

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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