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

28 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

322

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Egitto
    • Aswan Governorate
      • Aswān, Aswan Governorate, Egitto
        • Reclutamento
        • Department of Urology- Aswan University Hospitals
        • Contatto:
          • Ahmed
        • Contatto:
        • Investigatore principale:
          • Ahmed S Ahmed, MD
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egitto
        • Reclutamento
        • Department of Urology- Beni-Suef University Hospitals
        • Investigatore principale:
          • Hany F Badawy, MD
        • Contatto:
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egitto
        • Reclutamento
        • Urology Department- Sohag university Hospital
        • Contatto:
        • Investigatore principale:
          • Ahmed M Elsherif, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore 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.
Droga: Placebo Capsule
Matching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.
Droga: 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.
Sperimentale: 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.
Droga: 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.
Droga: Tamsulosin
Tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.
Sperimentale: 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.
Droga: Placebo Capsule
Matching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.
Droga: 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.
Sperimentale: 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.
Droga: Tamsulosin
Tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Successful First-Attempt 10/12 Fr Ureteral Access Sheath Placement
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Requirement for Active Ureteral Dilatation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beni-Suef University

Investigatori

  • Investigatore principale: Hany F Badawy, MD, Faculty of Medicine, Beni-Suef University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 maggio 2026

Completamento primario (Stimato)

1 aprile 2027

Completamento dello studio (Stimato)

1 maggio 2027

Date di iscrizione allo studio

Primo inviato

28 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 maggio 2026

Primo Inserito (Effettivo)

3 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FMBS050526BadawyTAMAMINUAS
  • FMBSUREC/05052026/Badawy (Altro identificatore: FM-BSU REC)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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