Preoperative Tamsulosin 0.4 mg Single Daily Dose, Double Daily Dose Versus Tadalafil 5 mg Daily Dose Before Retrograde Intrarenal Surgery; A Prospective Randomized Study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202605538229860

Enrollment

180

Registered

2026-05-15

Start date

2026-03-29

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urological and Genital Diseases

Interventions

tamsulosin 0.4 mg once daily

tamsulosin 0.4 mg twice daily

Tadalafil 5 mg once daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years 2. Scheduled for RIRS for renal calculi 3. Stone size 5-30 mm on imaging 4. Normal renal function (eGFR >60 mL/min/1.73 m²) 5. Ability to provide written informed consent 6. Willing and able to comply with study protocol

Exclusion criteria

Exclusion criteria: 1. Previous ureteral surgery or instrumentation within 6 months 2. Known ureteral stricture or anatomical abnormalities 3. Active urinary tract infection at enrollment 4. Pregnant or breastfeeding women 5. History of hypersensitivity to alpha blockers or tadalafil 6. Current use of alpha blockers, phosphodiesterase inhibitors, or nitrates 7. Severe cardiovascular disease (NYHA Class III-IV heart failure, recent MI within 3 months) 8. Hypotension (systolic BP 160/100 mmHg) 9. Severe hepatic impairment (Child-Pugh Class C) 10. History of priapism or conditions predisposing to priapism 11. Hereditary degenerative retinal disorders 12. Bilateral renal stones requiring staged procedures 13. Solitary kidney with stone burden >20 mm 14. Concurrent enrollment in another interventional trial

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of preoperative tamsulosin 0.4 mg single daily dose, tamsulosin 0.4 mg double daily dose, and tadalafil 5 mg daily dose in facilitating ureteroscope access during RIRS.	—

Secondary

Measure	Time frame
1. To assess the rate of successful ureteroscope insertion without the need for additional ureteral dilatation 2. To compare the incidence of intraoperative complications among the three groups 3. To evaluate postoperative complications and adverse events 4. To assess stone-free rates at 30 days post-procedure 5. To compare operative time and need for ureteral stenting 6. To evaluate patient-reported pain scores and quality of life measures 7. To assess medication tolerability and side effect profiles 8. To compare cost-effectiveness of the three treatment arms	—

Measure

Time frame

1. To assess the rate of successful ureteroscope insertion without the need for additional ureteral dilatation 2. To compare the incidence of intraoperative complications among the three groups 3. To evaluate postoperative complications and adverse events 4. To assess stone-free rates at 30 days post-procedure 5. To compare operative time and need for ureteral stenting 6. To evaluate patient-reported pain scores and quality of life measures 7. To assess medication tolerability and side effect profiles 8. To compare cost-effectiveness of the three treatment arms

—

Countries

Egypt

Contacts

Public ContactAhmed Eissa

Lecturer of Urology

ahmed.essa@med.tanta.edu.eg+201110304666

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026