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Набор скоро начнётся NCT07276919

Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy

Фаза IV С лечением Acute Urinary Retention LUTS(Lower Urinary Tract Symptoms)

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 0.2mg.
Кому может быть актуально
Состояния в реестре: Acute Urinary Retention, LUTS(Lower Urinary Tract Symptoms). Базовые параметры: 40 лет — 85 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
Китай
Следующий шаг
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Официальное название

Perioperative Tamsulosin for Treating Voiding Dysfunction Following Prostate Biopsy: A Multicenter, Randomized, Controlled, Open-Label Study

Обзор

The goal of this clinical trial is to learn if the drug Tamsulosin Hydrochloride works to treat urination difficulties after a prostate biopsy in men.The main questions it aims to answer are: * Does Tamsulosin Hydrochloride lower the rate of Acute Urinary Retention (inability to urinate) after a prostate biopsy? * Does Tamsulosin Hydrochloride improve participants' urination symptoms, quality of life, urine flow rate, and post-void residual urine volume? Researchers will compare the drug group to a control group (receiving no preventive medication) to see if Tamsulosin Hydrochloride works to prevent urination problems. Participants will: * Be randomly assigned to either take Tamsulosin Hydrochloride or receive no preventive medication. * If in the drug group, take one capsule of Tamsulosin Hydrochloride every night, starting 3 days before the biopsy and continuing until 6 days after the biopsy (10 doses total). * Undergo a standard prostate biopsy procedure (either through the rectum or perineum). * Return to the clinic 7 days after the biopsy for a follow-up checkup, which will include questions about their symptoms (IPSS and QoL scores) and tests to measure urine flow and bladder emptying.

Подробное описание

This study is designed as a multicenter, randomized, controlled, open-label trial. Participants will be randomized 1:1 into two groups using a block randomization method. The experimental group will receive Tamsulosin Hydrochloride Sustained-Release Capsules (0.2 mg, once daily at night) starting 3 days before the biopsy and continuing until the 6th day after the procedure (10 doses total). The control group will not receive Tamsulosin during this perioperative period. All patients will undergo standard pre-biopsy preparations, including bowel preparation and prophylactic antibiotics. The primary endpoint, Acute Urinary Retention (AUR) incidence, along with secondary endpoints (IPSS, QoL, urinary flow rate, post-void residual urine), will be assessed on the 7th day after the biopsy. Safety indicators, such as the incidence of adverse events like orthostatic hypotension and falls, will also be monitored.

Вмешательства

  • Препарат Tamsulosin 0.2mg
    The experimental group will receive Tamsulosin Hydrochloride Sustained-Release Capsules (0.2 mg, once daily at night) starting 3 days before the biopsy and continuing until the 6th day after the procedure (10 doses total).

Первичные конечные точки

  • Incidence of AUR [Срок оценки: From biopsy to the 7th day after biopsy.]
Вторичные конечные точки (4)
  • IPSS [Срок оценки: From baseline (pre-biopsy) to the 7th day after biopsy.]
  • QoL [Срок оценки: From baseline (pre-biopsy) to the 7th day after biopsy.]
  • Qmax [Срок оценки: From baseline (pre-biopsy) to the 7th day after biopsy.]
  • PVR [Срок оценки: From baseline (pre-biopsy) to the 7th day after biopsy.]

Критерии участия

Критерии включения

  • Male, aged 40 to 85 years (inclusive).
  • Meets indications for prostate biopsy per clinical guidelines (e.g., suspicious nodule on digital rectal exam, suspicious lesion on imaging, tPSA >10 ng/mL, or tPSA 4-10 ng/mL with f/t <0.16 or PSAD >0.15).
  • Voluntarily participates and provides written informed consent.

Критерии исключения

  • Previous prostate surgery, urinary diversion, or intermittent catheterization.
  • Use of alpha-adrenergic blockers (e.g., Tamsulosin, Doxazosin) within one week prior to screening.
  • Known or suspected allergy/intolerance to Tamsulosin, or history of orthostatic hypotension.
  • Indwelling urinary catheter or suprapubic cystostomy tube at the time of biopsy.
  • History of severe bleeding disorders.
  • Poorly controlled or unstable comorbidities such as hypertension or diabetes.
  • Severe immunosuppression.
  • Severe psychological disorders or uncooperative for the biopsy procedure.
  • Active urinary tract infection or neurogenic bladder.
  • Any other condition deemed by the investigator as unsuitable for participation.

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Peking University First Hospital, Urology Department — Пекин

Идентификаторы

NCT: NCT07276919 · 20251018

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗