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Идёт набор NCT07188064

A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery

Без фазы С лечением Prostate Cancer Erectile Dysfunction Following Radical Prostatectomy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Post radical prostatectomy nerve restoration procedure (PRP-NR).
Кому может быть актуально
Состояния в реестре: Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective Cohort Study of Somatic-Autonomic Nerve Grafting Technique to Restore Erectile Function in Patients With Persistent Erectile Dysfunction Post Radical Prostatectomy

Обзор

A single arm prospective pilot trial evaluating the 1-year erectile recovery outcomes and the safety of patients undergoing a somatic to autonomic nerve grafting procedure for restoration of erectile function in patients who have lost erectile function following radical prostatectomy for prostate cancer. During this study a total of 100 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a post radical prostatectomy nerve restoration procedure (PRP-NR).

Подробное описание

The investigators are proposing a single arm prospective pilot study evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing the PRP-NR procedure. A total of 100 patients will undergo the PRP-NR procedure, which is a novel nerve grafting procedure which will utilize a graft of the ilioinguial nerve to perform a bilateral end to side connection between the dorsal penile nerve and the corpora cavernosa with the intent to restore erectile function. Participants will have a baseline evaluation with IIEF-5 and SF-MPQ questionnaires, and then will have re-evaluation with these questionnaires at their standard of care post operative visits at 4 weeks, 3-, 6-, 12-, 18- and 24- months. Post operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care.

Вмешательства

  • Процедура Post radical prostatectomy nerve restoration procedure (PRP-NR)
    Somatic to autonomic nerve grafting procedure which uses a nerve graft of ilioinguinal nerve harvested from the inguinal canal to perform a bilateral end to side junction between the dorsal penile nerve and the penile corpora cavernosa

Первичные конечные точки

  • International Index of Erectile Function-5 (IIEF-5) [Срок оценки: 4 weeks post PRP-NR]
  • International Index of Erectile Function-5 (IIEF-5) [Срок оценки: 3 months post PRP-NR]
  • Clinical Evolution of Erectile Function (CEEF) [Срок оценки: 24 months post PRP-NR]
  • Clinical Evolution of Erectile Function (CEEF) [Срок оценки: 18 months post PRP-NR]
  • Clinical Evolution of Erectile Function (CEEF) [Срок оценки: 12 months post PRP-NR]
  • Clinical Evolution of Erectile Function (CEEF) [Срок оценки: 6 months post PRP-NR]
  • Clinical Evolution of Erectile Function (CEEF) [Срок оценки: 3 months post PRP-NR]
  • Clinical Evolution of Erectile Function (CEEF) [Срок оценки: 4 weeks post PRP-NR]
  • Short Form McGill Pain Questionnaire (SF-MPQ) [Срок оценки: 24 months post PRP-NR]
  • Short Form McGill Pain Questionnaire (SF-MPQ) [Срок оценки: 18 months post PRP-NR]
Вторичные конечные точки (1)
  • The secondary outcome is specifically the safety of the operation. This will be measured by adverse events as defined by the Clavian-Dindo classification.The measurement varies from Grade I (Best possible outcome) to Grade V (Worst possible outcome). [Срок оценки: Through study completion, an average of 2 years]

Критерии участия

Критерии включения

  • Patients with persistent post prostatectomy erectile dysfunction as defined below:
  • Severe ED (IIEF score 5-7) and more than 12 months from prostatectomy OR
  • Moderate ED (IIEF score 8-11) and more than 18 months from prostatectomy
  • Patients must have had good pre-prostatectomy erectile function with a baseline IIEF score of ≥17 on self-reported assessment of historic function.

Критерии исключения

  • Patients aged < 18 years at diagnosis
  • Legally incapable patients
  • Patients >5 years from prostatectomy.
  • Bilateral open inguinal hernia repair
  • Patients with pre-existing significant neurologic disease
  • Diabetes with evidence of peripheral nerve involvement and end organ dysfunction
  • Coronary artery disease with unstable angina
  • Mood disorder (anxiety/depression) with change in medical therapy within last 3 months
  • Pre-existing penile base surgery which would prevent grafting technique including suprapubic liposuction, suspensory ligament release
  • Pre-existing penile prosthesis
  • Current use of androgen deprivation therapy
  • Use of medications for chronic nerve pain (gabapentin, amitriptyline, nortriptyline, pregablin)
  • Previous untreated penile trauma
  • Patients deemed medically unfit for surgery

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Jewish General Hospital — Montreal

Идентификаторы

NCT: NCT07188064 · MP-05-2026-4654

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗