Renal StonesPhase 2TAM-AMIN-UASNCT07623876
Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS
A Phase 2 study testing Tamsulosin and Intraureteral Aminophylline in people with Renal Stones and Retrograde Intrarenal Surgery, run by Beni-Suef University at 3 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stones, Retrograde Intrarenal Surgery, Ureteral Access Sheath Placement
- What is being tested?
- Tamsulosin and Intraureteral Aminophylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 3 sitesEgypt
- Study dates
- 6 May 2026to May 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt3 sites, 3 recruiting
- Recruiting
Department of Urology- Aswan University Hospitals
Aswān, Aswan Governorate
Ahmed Ahmed, MD, +20 11 00299002, ahmed.salaheldien@aswu.edu.eg
Ahmed
- Recruiting
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate
Hany F Badawy, MD, +2, Hanyfathy86@gmail.com
Hany F Badawy, MD
- Recruiting
Urology Department- Sohag university Hospital
Sohag, Sohag Governorate
Ahmed M Elsherif, MD, +20 10 07385302, Ahmed-mahmoud@med.sohag.edu.eg
Ahmed M Elsherif, MD
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Tamsulosin, Placebo Capsule, Intraureteral Aminophylline, Intraureteral Placebo
- Keywords
- Retrograde intrarenal surgery, Tamsulosin, Intraureteral aminophylline, ureteral access sheath
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.
Placebo CapsuleDrug
Matching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.
Intraureteral AminophyllineDrug
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.
Intraureteral PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Tamsulosin; Drug: Intraureteral Aminophylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the index retrograde intrarenal surgery procedure
Secondary outcomes (4)
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.
Measured: During the index retrograde intrarenal surgery procedure
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.
Measured: During the index retrograde intrarenal surgery procedure
Access-Related Ureteral Injury
Occurrence of access-related ureteral injury during ureteral access sheath insertion, graded endoscopically where feasible.
Measured: During the index retrograde intrarenal surgery procedure
Postoperative Pain Score
Postoperative pain intensity assessed after the index procedure using the study pain assessment method.
Measured: Within 24 hours after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start6 May 2026
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Fathy Badawy, MD, Beni-Suef University
- Investigators
- Hany F Badawy, MD, Principal investigator, Faculty of Medicine, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623876
- Sponsor's protocol ID
- FMBS050526BadawyTAMAMINUAS
- Other IDs
- FMBSUREC/05052026/Badawy
- Acronym
- TAM-AMIN-UAS
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.