Tamsulosin hydrochloride for Nephrolithiasis | Ureteral stone

Inclusion criteria

• {"criterion_text":"- Patients with kidney and proximally located ureteral stones with diameter < 2 cm\n- Patients >18 years\n- Able to understand the study procedures and willing to provide signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Symptoms of urinary tract infection\n- Ureteral or nephrostomy stent placement prior to the intervention\n- Multiple stones\n- Renal functional deterioration\n- Severe hydronephrosis\n- Hypotension\n- Solitary kidney\n- Ectopic kidney and other anatomical anomalies\n- Patients have other disorders such as heart disease, kidney failure\n- Positive pregnancy test or fertile women without safety contraception\n- Allergy to one of the ingredients in the trial medicine"}

Primary endpoints

• {"endpoint_text":"- Stone clearance: A stone-free condition is defined as the complete absence of any stone or the presence of residual fragments smaller than 3 mm in diameter and should be evaluated 4 weeks after last treatment with Non-contrast CT.","definition_or_measurement_approach":"Stone-free defined as complete absence of any stone or residual fragments <3 mm; evaluated 4 weeks after last treatment using Non-contrast CT."}

Secondary endpoints

• {"endpoint_text":"- Clinical outcomes and success as measured in terms of stone-free rate after ESWL is strongly correlated to pain experienced during and after the treatment. The secondary outcomes will be: •\tCompare pain during and post ESWL period using a validated VAS. Combination of the two types of medicine is going to be evaluated on the degree of the pain relief. The intensity of their pain will be assessed in three phases; •\tDuring the two sessions of ESWL and 2 weeks after the last procedure.","definition_or_measurement_approach":"Pain compared during and post-ESWL using a validated Visual Analogue Scale (VAS); intensity assessed during the two ESWL sessions and up to 2 weeks after the last procedure."}

Denmark

Earliest CTIS Part Ii Submission Date

02-04-2024

Latest Decision Or Authorization Date

28-04-2024

Processing Time Days

26

Number Of Sites

1

Number Of Participants

500

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties codes: 1, 9","organisation_type":"Educational Institution"}