Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS

NCT07623876 | Recruiting Phase 2

• 2 other identifiers: FMBS050526BadawyTAMAMINUASFMBSUREC/05052026/Badawy
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Renal Stones; Retrograde Intrarenal Surgery; Ureteral Access Sheath Placement

Keywords

Retrograde intrarenal surgery; Tamsulosin; Intraureteral aminophylline; ureteral access sheath

Outcome Measures

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.

  During the index retrograde intrarenal surgery procedure

Secondary Outcomes (4)

• Requirement for Active Ureteral Dilatation

  During the index retrograde intrarenal surgery procedure

• Requirement for Prestenting and Staged RIRS

  During the index retrograde intrarenal surgery procedure

• Access-Related Ureteral Injury

  During the index retrograde intrarenal surgery procedure

• Postoperative Pain Score

  Within 24 hours after the index procedure

Study Arms (4)

Placebo Capsule Plus Intraureteral Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo Capsule; Drug: Intraureteral Placebo

Tamsulosin Plus Intraureteral Placebo

EXPERIMENTAL

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.

Drug: Tamsulosin; Drug: Intraureteral Placebo

Placebo Capsule Plus Intraureteral Aminophylline

EXPERIMENTAL

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.

Drug: Placebo Capsule; Drug: Intraureteral Aminophylline

Tamsulosin Plus Intraureteral Aminophylline

EXPERIMENTAL

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.

Drug: Tamsulosin; Drug: Intraureteral Aminophylline

Interventions

Tamsulosin DRUG

Tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.

Tamsulosin Plus Intraureteral Aminophylline; Tamsulosin Plus Intraureteral Placebo

Placebo Capsule DRUG

Matching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.

Placebo Capsule Plus Intraureteral Aminophylline; Placebo Capsule Plus Intraureteral Placebo

Intraureteral Aminophylline DRUG

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.

Placebo Capsule Plus Intraureteral Aminophylline; Tamsulosin Plus Intraureteral Aminophylline

Intraureteral Placebo DRUG

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.

Placebo Capsule Plus Intraureteral Placebo; Tamsulosin Plus Intraureteral Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (3)

Department of Urology- Aswan University Hospitals

Aswān, Aswan Governorate, Egypt

RECRUITING

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

RECRUITING

Urology Department- Sohag university Hospital

Sohag, Sohag Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Hany F Badawy, MD

  Faculty of Medicine, Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; Hanyfathy86@gmail.com@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Preoperative capsules will be identical in appearance, packaging, and labeling. Intraureteral study solutions will be prepared in identical syringes of equal volume by personnel not involved in surgery, postoperative assessment, or data analysis. Participants, care providers, investigators, and outcome assessors will remain blinded to treatment allocation whenever feasible.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: Participants will be randomized in a 1:1:1:1 ratio in a multicenter 2x2 factorial design to receive preoperative tamsulosin or placebo and intraureteral aminophylline or intraureteral placebo before attempted placement of a planned ureteral access sheath during primary retrograde intrarenal surgery.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)