Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

28 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

322

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Egypte
    • Aswan Governorate
      • Aswān, Aswan Governorate, Egypte
        • Recrutement
        • Department of Urology- Aswan University Hospitals
        • Contact:
          • Ahmed
        • Contact:
        • Chercheur principal:
          • Ahmed S Ahmed, MD
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypte
        • Recrutement
        • Department of Urology- Beni-Suef University Hospitals
        • Chercheur principal:
          • Hany F Badawy, MD
        • Contact:
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egypte
        • Recrutement
        • Urology Department- Sohag university Hospital
        • Contact:
        • Chercheur principal:
          • Ahmed M Elsherif, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur 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.
Médicament: Placebo Capsule
Matching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.
Médicament: 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.
Expérimental: 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.
Médicament: 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.
Médicament: Tamsulosin
Tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.
Expérimental: 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.
Médicament: Placebo Capsule
Matching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.
Médicament: 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.
Expérimental: 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.
Médicament: Tamsulosin
Tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Successful First-Attempt 10/12 Fr Ureteral Access Sheath Placement
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Requirement for Active Ureteral Dilatation
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Beni-Suef University

Les enquêteurs

  • Chercheur principal: Hany F Badawy, MD, Faculty of Medicine, Beni-Suef University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 mai 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 mai 2027

Dates d'inscription aux études

Première soumission

28 mai 2026

Première soumission répondant aux critères de contrôle qualité

28 mai 2026

Première publication (Réel)

3 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • FMBS050526BadawyTAMAMINUAS
  • FMBSUREC/05052026/Badawy (Autre identifiant: FM-BSU REC)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner