Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeni-Suef University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Factorial
Treatments tested in this trial
Tamsulosin
DrugTamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.
Placebo Capsule
DrugMatching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.
Intraureteral Aminophylline
DrugAminophylline 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.
Intraureteral Placebo
DrugNormal 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.
Treatment groups
322 Participants
are divided into 4 treatment groupsGroup A: Placebo Capsule Plus Intraureteral PlaceboPlacebo comparator 2 interventions
Group B: Tamsulosin Plus Intraureteral PlaceboExperimental treatment 2 interventions
Group C: Placebo Capsule Plus Intraureteral AminophyllineExperimental treatment 2 interventions
Group D: Tamsulosin Plus Intraureteral AminophyllineExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Successful First-Attempt 10/12 Fr Ureteral Access Sheath Placement
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.
Time frame
During the index retrograde intrarenal surgery procedureSecondary outcomes
1
Requirement for Active Ureteral Dilatation
Proportion of participants requiring active ureteral dilatation after unsuccessful first standardized post-instillation placement of the planned 10/12 Fr ureteral access sheath.
Time frame
During the index retrograde intrarenal surgery procedure2
Requirement for Prestenting and Staged RIRS
Proportion of participants requiring ureteral stenting with deferred retrograde intrarenal surgery because of unsuccessful or unsafe ureteral access during the index procedure.
Time frame
During the index retrograde intrarenal surgery procedure3
Access-Related Ureteral Injury
Occurrence of access-related ureteral injury during ureteral access sheath insertion, graded endoscopically where feasible.
Time frame
During the index retrograde intrarenal surgery procedure4
Postoperative Pain Score
Postoperative pain intensity assessed after the index procedure using the study pain assessment method.
Time frame
Within 24 hours after the index procedureSponsors and contacts
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Source ClinicalTrials.gov