Идёт набор NCT07654413

Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia

Фаза IV С лечением Acute Urinary Retention Benign Prostatic Hyperplasia Benign Prostatic Obstruction

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: Tamsulosin, Tadalafil, Tadalafil Placebo.
Кому может быть актуально: Состояния в реестре: Acute Urinary Retention, Benign Prostatic Hyperplasia, Benign Prostatic Obstruction. Базовые параметры: от 50 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: Египет
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

Tamsulosin With Versus Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Prospective Double-Blind Randomized Trial

Обзор

Acute urinary retention is a common emergency in men with benign prostatic hyperplasia. After bladder drainage with a urethral catheter, patients usually undergo a trial without catheter to determine whether they can pass urine again without recatheterization. This study will evaluate whether adding tadalafil 5 mg once daily to tamsulosin 0.4 mg once daily improves the chance of successful trial without catheter in men with first-episode acute urinary retention due to presumed benign prostatic hyperplasia. Participants will be randomly assigned to receive either tamsulosin plus tadalafil or tamsulosin plus a matching placebo. Study medication will start within 24 hours after catheterization. The catheter will be removed on Day 7. If the first trial without catheter fails, the catheter will be reinserted and a second rescue trial without catheter will be performed on Day 14. The main outcome is overall catheter-free success by Day 14. Participants will also be followed for recurrent urinary retention, post-void residual urine, urinary flow, catheter-related complications, drug-related adverse events, and the need for benign prostatic hyperplasia-related surgery within 3 months.

Вмешательства

Препарат Tamsulosin
Tamsulosin 0.4 mg will be administered orally once daily as open-label background therapy in both study arms. Treatment will start within 24 hours after urethral catheterization and continue until the scheduled Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue treatment until the rescue trial without catheter on Day 14.
Препарат Tadalafil
Tadalafil 5 mg will be administered orally once daily in the experimental arm in addition to open-label tamsulosin 0.4 mg once daily. Treatment will start within 24 hours after urethral catheterization and continue until the scheduled Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue treatment until the rescue trial without catheter on Day 14.
Препарат Tadalafil Placebo
A matching placebo tablet will be administered orally once daily in the placebo comparator arm in addition to open-label tamsulosin 0.4 mg once daily. The placebo will be identical to tadalafil in appearance, packaging, and labeling to maintain blinding.

Первичные конечные точки

Overall Catheter-Free Success by Day 14 [Срок оценки: Day 14]

Вторичные конечные точки (4)

Successful Day-7 Trial Without Catheter [Срок оценки: Day 7]
Successful Rescue Day-14 Trial Without Catheter Among Day-7 Failures [Срок оценки: Day 14]
Recurrent Acute Urinary Retention Within 30 Days [Срок оценки: 30 days]
Need for Benign Prostatic Hyperplasia-Related Surgery Within 3 Months [Срок оценки: 3 months]

Критерии участия

Критерии включения

Male patient aged 50 years or older.
First episode of spontaneous painful acute urinary retention.
Successful urethral catheterization at presentation.
Drained urine volume at presentation of at least 300 mL.
Clinical impression of benign prostatic obstruction or benign prostatic hyperplasia based on history, digital rectal examination, and/or ultrasound evidence of enlarged prostate.
Ability to provide written informed consent.