Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia (TAMS-TAD-TWOC)
2026年6月12日 更新者：Hany Fathy Badawy, MD、Beni-Suef University
Tamsulosin With Versus Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Prospective Double-Blind Randomized Trial
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.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
320
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Hany F Badawy, MD
- 電話番号：+201149525028
- メール：HANYFATHY86@GMAIL.COM
研究場所
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Beni Suweif Governorate
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Banī Suwayf、Beni Suweif Governorate、エジプト、02456
- 募集
- Department of Urology- Beni-Suef University Hospitals
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コンタクト：
- Hany F Badawy, MD
- 電話番号：+201149525028
- メール：HANYFATHY86@GMAIL.COM
-
主任研究者：
- Hany F Badawy, MD
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コンタクト：
-
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Previous episode of acute urinary retention.
- Chronic painless urinary retention phenotype.
- Active urinary tract infection or sepsis.
- Gross hematuria with clot retention.
- Suspected or known urethral stricture.
- Neurogenic bladder or major neurologic disease affecting voiding.
- History of prostate cancer or bladder cancer.
- Previous prostate surgery.
- Current use of nitrates or guanylate cyclase stimulators.
- Contraindication to tadalafil or tamsulosin.
- Severe hypotension or unstable cardiovascular disease.
- Severe renal impairment.
- Severe hepatic impairment.
- Current or recent use of phosphodiesterase type 5 inhibitors before enrollment.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：Tamsulosin Plus Placebo
Participants will receive tamsulosin 0.4 mg once daily plus a matching placebo once daily.
Treatment will start within 24 hours after urethral catheterization and continue until the Day-7 trial without catheter.
Participants who fail the Day-7 trial without catheter will continue the assigned treatment until the rescue trial without catheter on Day 14.
|
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.
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.
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実験的：Tamsulosin Plus Tadalafil
Participants will receive tamsulosin 0.4 mg once daily plus tadalafil 5 mg once daily.
Treatment will start within 24 hours after urethral catheterization and continue until the Day-7 trial without catheter.
Participants who fail the Day-7 trial without catheter will continue the assigned treatment until the rescue trial without catheter on Day 14.
|
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.
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall Catheter-Free Success by Day 14
時間枠：Day 14
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Proportion of participants who achieve successful spontaneous voiding after either the scheduled Day-7 trial without catheter or the rescue Day-14 trial without catheter.
Success is defined as spontaneous voiding after catheter removal, voided volume of at least 100 mL, post-void residual urine less than 150 mL measured within 10-15 minutes after voiding, no recatheterization within 24 hours after the relevant trial without catheter attempt, and remaining catheter-free until Day 14 for participants who initially pass the Day-7 trial without catheter.
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Day 14
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Successful Day-7 Trial Without Catheter
時間枠：Day 7
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Proportion of participants who achieve successful spontaneous voiding after catheter removal on Day 7. Success is defined as spontaneous voiding, voided volume of at least 100 mL, post-void residual urine less than 150 mL measured within 10-15 minutes after voiding, and no recatheterization within 24 hours.
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Day 7
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Successful Rescue Day-14 Trial Without Catheter Among Day-7 Failures
時間枠：Day 14
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Proportion of participants who fail the Day-7 trial without catheter and subsequently achieve successful rescue trial without catheter on Day 14 using the same predefined success criteria: spontaneous voiding, voided volume of at least 100 mL, post-void residual urine less than 150 mL measured within 10-15 minutes after voiding, and no recatheterization within 24 hours.
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Day 14
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Recurrent Acute Urinary Retention Within 30 Days
時間枠：30 days
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Proportion of participants who develop recurrent painful acute urinary retention requiring recatheterization within 30 days after randomization.
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30 days
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Need for Benign Prostatic Hyperplasia-Related Surgery Within 3 Months
時間枠：3 months
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Proportion of participants who require surgical intervention for benign prostatic hyperplasia or benign prostatic obstruction within 3 months after randomization.
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3 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月8日
一次修了 (推定)
2027年11月1日
研究の完了 (推定)
2027年12月1日
試験登録日
最初に提出
2026年6月12日
QC基準を満たした最初の提出物
2026年6月12日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月17日
QC基準を満たした最後の更新が送信されました
2026年6月12日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- BSU FMBSUREC07062026CBADAWY
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be shared publicly because the study includes individual-level urological and treatment-related clinical data, and participant-level data sharing is not currently included in the ethics approval or informed consent.
Only aggregated, de-identified results will be reported in publications or presentations.
Any future sharing of de-identified participant-level data would require additional approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University, and an appropriate data-sharing agreement.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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