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Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS (TAM-AMIN-UAS)

28 maja 2026 zaktualizowane przez: Hany Fathy Badawy, MD, Beni-Suef University

Comparative Efficacy of Tamsulosin, Intraureteral Aminophylline, and Their Combination in Facilitating Ureteral Access During Retrograde Intrarenal Surgery: A Multicenter Randomized Controlled Trial.

This multicenter randomized controlled trial will evaluate whether preoperative tamsulosin, intraureteral aminophylline, or their combination can improve ureteral access during primary retrograde intrarenal surgery for renal stones. Adult patients with unilateral renal stones measuring 2 cm or less and planned placement of a 10/12 Fr ureteral access sheath will be randomly assigned to one of four groups in a 2x2 factorial design. Participants will receive either tamsulosin or placebo for 7 days before surgery and either intraureteral aminophylline or intraureteral placebo during the procedure. The main outcome will be successful first-attempt placement of the planned 10/12 Fr ureteral access sheath after study solution instillation, without active ureteral dilatation, sheath downsizing, prestenting with deferred surgery, or abandonment of the procedure due to access failure.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

Retrograde intrarenal surgery is a commonly used minimally invasive procedure for the treatment of renal stones. Successful completion of the procedure may require placement of a ureteral access sheath. However, ureteral access sheath insertion can be difficult in some patients because of ureteral resistance or spasm, which may lead to ureteral trauma, active ureteral dilatation, prestenting with delayed surgery, or inability to complete the planned procedure.

This study is designed to compare systemic, local, and combined pharmacologic strategies for facilitating ureteral access during primary retrograde intrarenal surgery. Tamsulosin is an alpha-1 adrenergic receptor blocker that may reduce ureteral tone when given before surgery. Aminophylline is a smooth-muscle relaxant that may reduce ureteral spasm when administered locally into the ureter during the procedure.

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial with a 2x2 factorial design. Eligible adult patients with unilateral renal stones measuring 2 cm or less who are scheduled for primary retrograde intrarenal surgery with planned 10/12 Fr ureteral access sheath placement will be randomized in a 1:1:1:1 ratio. The four treatment combinations are: placebo capsule plus intraureteral placebo, tamsulosin capsule plus intraureteral placebo, placebo capsule plus intraureteral aminophylline, and tamsulosin capsule plus intraureteral aminophylline.

Patients assigned to tamsulosin will receive tamsulosin 0.4 mg once daily for 7 days before surgery, while patients assigned to placebo will receive a matching placebo capsule. During surgery, the assigned intraureteral solution will be instilled through an open-end ureteric catheter positioned in the distal ureter on the study side. After a standardized 5-minute waiting period, one controlled attempt will be made to place the planned 10/12 Fr ureteral access sheath.

The primary endpoint is successful first-attempt placement of the planned 10/12 Fr ureteral access sheath after study solution instillation, without active ureteral dilatation, sheath downsizing, prestenting with deferred retrograde intrarenal surgery, or abandonment of the procedure due to access failure. If the planned sheath cannot be inserted safely, management will proceed according to a predefined rescue pathway, including active ureteral dilatation if considered safe or ureteral stenting with deferred surgery. Forced sheath advancement against marked resistance will be avoided.

Secondary outcomes will assess flexible ureteroscope advancement, need for rescue maneuvers, access-related ureteral injury, operative outcomes, postoperative pain, complications, hospital stay, and stone-free status during follow-up.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

322

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Egipt
    • Aswan Governorate
      • Aswān, Aswan Governorate, Egipt
        • Rekrutacyjny
        • Department of Urology- Aswan University Hospitals
        • Kontakt:
          • Ahmed
        • Kontakt:
        • Główny śledczy:
          • Ahmed S Ahmed, MD
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egipt
        • Rekrutacyjny
        • Department of Urology- Beni-Suef University Hospitals
        • Główny śledczy:
          • Hany F Badawy, MD
        • Kontakt:
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egipt
        • Rekrutacyjny
        • Urology Department- Sohag university Hospital
        • Kontakt:
        • Główny śledczy:
          • Ahmed M Elsherif, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Age 18 years or older.
  • Unilateral renal stone 2 cm or less in maximal diameter on preoperative imaging.
  • Scheduled for primary retrograde intrarenal surgery.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Prior ureteral stenting on the study side.
  • Bilateral same-session retrograde intrarenal surgery.
  • Concomitant ureteral stone requiring primary semirigid ureteroscopy as the main procedure.
  • Known ureteral stricture or prior ureteral reconstructive surgery on the study side.
  • Active urinary tract infection or untreated positive urine culture.
  • Pregnancy.
  • Known allergy or contraindication to tamsulosin or aminophylline.
  • Significant cardiac arrhythmia, uncontrolled ischemic heart disease, seizure disorder, or hyperthyroidism.
  • Severe hepatic impairment.
  • Inability to comply with the 7-day preoperative medication protocol.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przypisanie czynnikowe
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo Capsule Plus Intraureteral Placebo
Participants will receive a matching placebo capsule once daily for 7 days before retrograde intrarenal surgery and intraureteral placebo using normal saline 0.9% during the procedure before attempted placement of the planned 10/12 Fr ureteral access sheath.
Lek: Placebo Capsule
Matching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.
Lek: Intraureteral Placebo
Normal saline 0.9% to a total volume of 20 mL will be instilled intraureterally through an open-end ureteric catheter positioned in the distal ureter on the study side. After a standardized 5-minute waiting period, one controlled attempt will be made to place the planned 10/12 Fr ureteral access sheath.
Eksperymentalny: Tamsulosin Plus Intraureteral Placebo
Participants will receive tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery and intraureteral placebo using normal saline 0.9% during the procedure before attempted placement of the planned 10/12 Fr ureteral access sheath.
Lek: Intraureteral Placebo
Normal saline 0.9% to a total volume of 20 mL will be instilled intraureterally through an open-end ureteric catheter positioned in the distal ureter on the study side. After a standardized 5-minute waiting period, one controlled attempt will be made to place the planned 10/12 Fr ureteral access sheath.
Lek: Tamsulosin
Tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.
Eksperymentalny: Placebo Capsule Plus Intraureteral Aminophylline
Participants will receive a matching placebo capsule once daily for 7 days before retrograde intrarenal surgery and intraureteral aminophylline solution during the procedure before attempted placement of the planned 10/12 Fr ureteral access sheath.
Lek: Placebo Capsule
Matching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.
Lek: Intraureteral Aminophylline
Aminophylline 250 mg/10 mL will be diluted with 10 mL normal saline 0.9% to a total volume of 20 mL. The solution will be instilled intraureterally through an open-end ureteric catheter positioned in the distal ureter on the study side. After a standardized 5-minute waiting period, one controlled attempt will be made to place the planned 10/12 Fr ureteral access sheath.
Eksperymentalny: Tamsulosin Plus Intraureteral Aminophylline
Participants will receive tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery and intraureteral aminophylline solution during the procedure before attempted placement of the planned 10/12 Fr ureteral access sheath.
Lek: Tamsulosin
Tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.
Lek: Intraureteral Aminophylline
Aminophylline 250 mg/10 mL will be diluted with 10 mL normal saline 0.9% to a total volume of 20 mL. The solution will be instilled intraureterally through an open-end ureteric catheter positioned in the distal ureter on the study side. After a standardized 5-minute waiting period, one controlled attempt will be made to place the planned 10/12 Fr ureteral access sheath.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Successful First-Attempt 10/12 Fr Ureteral Access Sheath Placement
Ramy czasowe: During the index retrograde intrarenal surgery procedure
Successful placement of the planned 10/12 Fr ureteral access sheath at the first standardized post-instillation attempt during primary retrograde intrarenal surgery, without active ureteral dilatation, sheath downsizing, prestenting with deferred retrograde intrarenal surgery, or abandonment of the procedure due to access failure.
During the index retrograde intrarenal surgery procedure

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Requirement for Active Ureteral Dilatation
Ramy czasowe: During the index retrograde intrarenal surgery procedure
Proportion of participants requiring active ureteral dilatation after unsuccessful first standardized post-instillation placement of the planned 10/12 Fr ureteral access sheath.
During the index retrograde intrarenal surgery procedure
Requirement for Prestenting and Staged RIRS
Ramy czasowe: During the index retrograde intrarenal surgery procedure
Proportion of participants requiring ureteral stenting with deferred retrograde intrarenal surgery because of unsuccessful or unsafe ureteral access during the index procedure.
During the index retrograde intrarenal surgery procedure
Access-Related Ureteral Injury
Ramy czasowe: During the index retrograde intrarenal surgery procedure
Occurrence of access-related ureteral injury during ureteral access sheath insertion, graded endoscopically where feasible.
During the index retrograde intrarenal surgery procedure
Postoperative Pain Score
Ramy czasowe: Within 24 hours after the index procedure
Postoperative pain intensity assessed after the index procedure using the study pain assessment method.
Within 24 hours after the index procedure

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Beni-Suef University

Śledczy

  • Główny śledczy: Hany F Badawy, MD, Faculty of Medicine, Beni-Suef University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 maja 2026

Zakończenie podstawowe (Szacowany)

1 kwietnia 2027

Ukończenie studiów (Szacowany)

1 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

28 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 maja 2026

Pierwszy wysłany (Rzeczywisty)

3 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • FMBS050526BadawyTAMAMINUAS
  • FMBSUREC/05052026/Badawy (Inny identyfikator: FM-BSU REC)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be shared because the study involves individual-level clinical and operative data from a multicenter interventional trial. Only aggregated, de-identified study results will be reported in publications. Any future data sharing request will require approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University, and the participating study centers.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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