the effects of tamsulosin 0.8 mg compared to 0.4 mg on distal ureteral stone passage

Study of the effects of oral tamsulosin 0.8 mg compared to 0.4 mg in passing of 5 -10 mm distal ureteral stones in adults : a randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251021067715N1

Enrollment

124

Registered

2025-12-19

Start date

2025-12-21

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Distal ureteral stone. Hydronephrosis with renal and ureteral calculous obstruction

Interventions

Intervention 1: Intervention group: Patients who receive tamsulosin at a double usual dose, i.e. 0.8 mg, to help pass ureteral stones. Patients take two tamsulosin 0.4 mg capsules, which are from the

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients older than 18 years with unilateral and solitary distal ureteral stone. The patient's distal ureteral stone size must be greater than or equal to 5 and less than 10 mm. Less than a week has passed since the patient's pain and symptoms began.

Exclusion criteria

Exclusion criteria: Patients who are not candidates for non-surgical treatment for any reason, including obstructive uropathy, symptoms of infection, patients with a single kidney, etc. pregnant women Patients who are taking interfering medications such as diuretics and are unable to discontinue them during the study.

Design outcomes

Primary

Measure	Time frame
Distal ureteral stone excretion rate. Timepoint: Check for the presence of distal ureteral stones before the start of the intervention and at the end of the third week or when the patient reports passing the stone. Method of measurement: CT scan of the abdomen and pelvis without contrast in the initial diagnosis, and ultrasound of the kidneys and urinary tract at the end of the examination to confirm whether or not the stone has been passed.	—

Measure

Time frame

Distal ureteral stone excretion rate. Timepoint: Check for the presence of distal ureteral stones before the start of the intervention and at the end of the third week or when the patient reports passing the stone. Method of measurement: CT scan of the abdomen and pelvis without contrast in the initial diagnosis, and ultrasound of the kidneys and urinary tract at the end of the examination to confirm whether or not the stone has been passed.

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Secondary

Measure	Time frame
Stone expulsion time. Timepoint: At the beginning of the study and at the time of reporting stone passage by the patient or by the end of the third week. Method of measurement: By calculating the number of days elapsed from the start of the intervention until the stone was passed or until the end of the third week.;Occurrence of postural hypotension. Timepoint: before the start of the intervention and at the end of the first, second and third weeks of the intervention and a week after the end of intervention. Method of measurement: Using a pressure gauge.	—

Measure

Time frame

Stone expulsion time. Timepoint: At the beginning of the study and at the time of reporting stone passage by the patient or by the end of the third week. Method of measurement: By calculating the number of days elapsed from the start of the intervention until the stone was passed or until the end of the third week.;Occurrence of postural hypotension. Timepoint: before the start of the intervention and at the end of the first, second and third weeks of the intervention and a week after the end of intervention. Method of measurement: Using a pressure gauge.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Alishooshtari

Ahvaz University of Medical Sciences

alireza.shoushtari2021@gmail.com+98 74 1222 9284

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026