Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Tamsulosin
  Tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.
• Препарат Placebo Capsule
  Matching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Successful First-Attempt 10/12 Fr Ureteral Access Sheath Placement [Срок оценки: During the index retrograde intrarenal surgery procedure]

Вторичные конечные точки (4)

• Requirement for Active Ureteral Dilatation [Срок оценки: During the index retrograde intrarenal surgery procedure]
• Requirement for Prestenting and Staged RIRS [Срок оценки: During the index retrograde intrarenal surgery procedure]
• Access-Related Ureteral Injury [Срок оценки: During the index retrograde intrarenal surgery procedure]
• Postoperative Pain Score [Срок оценки: Within 24 hours after the index procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Египет · 3 центра

• Department of Urology- Aswan University Hospitals — Aswān
• Department of Urology- Beni-Suef University Hospitals — Banī Suwayf
• Urology Department- Sohag university Hospital — Sohag

Идентификаторы

NCT: NCT07623876 · FMBS050526BadawyTAMAMINUAS · FMBSUREC/05052026/Badawy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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