References | Type of study | Inclusion criteria | Exclusion criteria | Number of subjects, follow-up period | Treatment | Efficacy | Safety |
---|---|---|---|---|---|---|---|
Jayant K et al. [2] | RCT | Patients aged 18 years or older with a ureteral stone 5–10 mm in size situated below the common iliac vessels, as diagnosed by non-contrast computed tomography | Patients with fever, hydronephrosis, acute or chronic renal insufficiency, multiple ureteral stones, open surgery or endoscopic interventions, diabetes, peptic ulcer or concomitant treatment with β-blockers, calcium antagonists, or nitrates, pregnant or lactating mothers, or requiring immediate intervention | 244, 4 weeks | Group A were given tamsulosin 0.4 mg once daily and group B were given tamsulosin 0.4 mg and tadalafil 10 mg once daily | Stone expulsion rate was 65.5% in group A and 83.6% in group B. The mean expulsion time in group A was 16.7 ± 4.8 days and in group B was 14.9 ± 4.4 days | Adverse effects-Group A: Headache, dizziness (12.3%), orthostatic hypotension (3.0%) and backache (9.8%), abnormal ejaculation (18.3%). Group B: Headache, dizziness, backache (15.8%), orthostatic hypotension (5.8%), abnormal ejaculation (12.3%) |
Gandhi HR et al. [3] | RCT | Patients with a solitary stone in the distal ureter, at the juxtavesical tract (JVT) or vesico-ureteric junction (VUJ) of 5–15 mm | Patients with a UTI, gross hydronephrosis, diabetes, peptic ulcer disease, hypersensitivity to nifedipine or corticosteroid or a history of spontaneous stone expulsion and hypotension, pregnant women, and children | 128, 4 weeks | Group 1 received oral nifedipine sustained release 30 mg/day and group B received tamsulosin 0.4 mg/day | Stone expulsion rate in group 1 was 55% and group 2 was 80%. Mean expulsion time for group 1 was 23 days and 9 days for group 2 | Adverse effects in group 1- Headache (43%), loose stool (24%), dizziness, fatigue, flushing (5%), palpitation muscle cramps (9%). Group 2- Headache (50%), gastric upset (25%), dizziness (25%) |
Sentürk AB et al. [5] | Retrospective observational study | Those patients who had calculi with the size of 4- 10 mm which were located under the common iliac arteries and confirmed by computerized tomography, and those responding to the analgesic treatment were included in the study | Those patients who had bilateral ureter calculi, severe urinary tract infection, severe colic attack, fever, severe hydronephrosis, renal impairment, history of endoscopic surgery due to ureter calculi and history of drug which interact with alpha blockers were excluded from the study | 143, 4 weeks | Tamsulosin 0.4 mg OD, alfuzosin 10 mg OD, silodosin 8 mg OD | Expulsion rate for tamsulosin group = 70.8%, alfuzosin group = 70.2%, silodosin group = 75%. Expulsion time in tamsulosin group = 10.41 ± 3.61 days, alfuzosin group = 8.87 ± 3.54 days, silodosin group = 8.09 ± 3.66 days | Adverse effects-. Hypotension (8.5%) in tamsulosin group, (4.5%) in silodosin group and (6.4%) in alfuzosin group. Retrograde ejaculation was more in silodosin group |
Kumar S et al. [6] | RCT | Patients aged 18 years with a ureteral stone of 5–10 mm in size in greatest dimension situated below the common iliac vessels as diagnosed by non-contrast computed tomography or ultrasonography kidney, ureter, and bladder (KUB) were included in this study. Patients were only included if their pain was relieved with diclofenac injection within 1 day | Patients with fever, hydronephrosis, acute or chronic renal insufficiency, multiple ureteral stones, open surgery or endoscopic interventions, diabetes, peptic ulcer or on concomitant treatment with beta-blockers, calcium antagonists, or nitrates; pregnant or lactating mothers or who demand immediate intervention were excluded | 285, 4 weeks | Group A-Tamsulosin 0.4 mg OD, group B- silodosin 8 mg OD, group C = tadalafil 10 mg OD | Expulsion rate in group A was found to be 64.4%, group B = 83.3%, group C = 66.67%. Mean expulsion time in group A was found to be 16.5 ± 4.6 days, group B = 14.8 ± 3.3 days, group C = 16.2 ± 4.2 days | Adverse effects in group A were found to be headache, dizziness (10%), backache (8.8%), orthostatic hypotension (6.6%), abnormal ejaculation (11.2%). Group B = Headache (12.2%), dizziness (8.8%), backache (10%), orthostatic hypotension (3%), abnormal ejaculation (15.6%). Group C = Headache, dizziness, backache (15.5%), orthostatic hypotension (10%), abnormal ejaculation (5.9%) |
Abdelaziz AS et al. [8] | RCT | Patients with single lower ureteral stones from 5 to 10 mm | Pregnancy, age below 18 years old, presence of urinary tract infection, renal insufficiency, solitary kidney, multiple stones, a previous history of distal ureter surgery, bilateral ureteral stones, moderate or severe hydronephrosis, current alpha-blocker use and allergic reaction to tamsulosin and trospium chloride | 126, follow-up visits were performed on days 7, 14, 21 and 30 | Group A received tamsulosin 0.4 mg OD and placebo twice daily. Patient in group B received tamsulosin 0.4 mg OD and trospium chloride 20 mg BID | Stone expulsion rate in group A was 75.8%, group B 90.62%. Mean time to stone expulsion was 17.35 ± 6.21 days in group A and 11.65 ± 5.32 days in group B | Adverse effects- Group A retrograde ejaculation (8.06%), orthostatic hypotension (3.2%), headache, dizziness, fatigue (4.83%), constipation, dry mouth (1.6%) and in group B, retrograde ejaculation (6.25%), orthostatic hypotension, headache, dizziness (3.1%), constipation, dry mouth (7.8%), fatigue (4.68%) |
Shabana W et al. [10] | RCT | Patients with a single radiopaque stone of ≤ 10 mm by plain abdominal radiograph of the KUB, stone located below the sacroiliac joint | Patients with UTI, severe hydronephrosis, pregnancy, hypertension, diabetes, ulcer disease, previous pelvic surgery or renal insufficiency | 240, 2 weeks | Group 1 patients received tamsulosin 0.4 mg daily, group 2 received tamsulosin 0.4 mg and methylprednisolone 8 mg daily. Group 3 patients received alfuzosin 10 mg daily and those in group 4 received alfuzosin 10 mg and methylprednisolone 8 mg daily | Stone free rate in: Group 1- 54.7%, group 2–71.9%, group 3–52.8% and group 4–73.6%. Median time for stone expulsion: Group 1- 13 days, group 2- 10 days, group 3- 12 days, group 4- 9 days | Adverse effects- Transient hyperglycaemia in group 2 (5.7%), group 4 (3.8%) |
Elgalaly H et al. [12] | RCT | Adult patients presented with a symptomatic, unilateral, single, uncomplicated distal ureteric stone of less than 10 mm | Single kidney, bilateral ureteric stones, renal impairment, UTI, high-grade hydronephrosis and any history of previous endoscopic or surgical interventions | 115, follow-up was performed every week, for 4 weeks | Group A (58 patients) received a single dose of silodosin (8 mg) daily, and group B (57 patients) received a single dose of tamsulosin (0.4 mg) daily for one month | Stone clearance rate in group A = 83%, in Group B = 57%. Mean stone expulsion time in group A = 16.7 days, in group B = 13.3 days | Group A: Orthostatic hypotension (3.8%), abnormal ejaculation (17.3%) Group B: Orthostatic hypotension (7.8%), abnormal ejaculation (5.9%) |
Goyal SK et al. [17] | Prospective study | Adult patients > 18 years, presenting with distal ureteric stones sized 6 to 10 mm | Patients with solitary kidney, history of previous surgery on same ureter, UTI, deteriorating renal function, Fever, hydronephrosis, acute or chronic renal failure, multiple ureteral stones, a history of open surgery or endoscopic procedures in the urinary tract, allergy to tamsulosin or tadalafil, concomitant treatment with α-blockers, calcium antagonists, or nitrates, pregnant or lactating mothers, patients who demanded urgent stone removal | 123, 4 weeks | Group A = tamsulosin 0.4 mg once daily, group B = tadalafil 10 mg once daily | Stone expulsion rate was 73.77% in group A and 69.35% in group B; mean expulsion time for tamsulosin group was found to be 9.38 ± 6.66 days and for tadalafil group was found to be 9.61 ± 7.47 days | Adverse effects: Group A-Headache, abnormal ejaculation (9.8%), dizziness (6.6%), backache (4.92%), orthostatic hypotension (3.28%), group B- headache (11.3%), dizziness (9.7%), backache (4.8%), orthostatic hypotension (3.2%), abnormal ejaculation (1.6%) |
Falahatkar S et al. [18] | RCT | Adult aged 18–64 years who suffered from renal colic and single distal ureteral stone smaller than 10 mm | Patient with fever more than 37.8ºC, GFR ≤ 30, single kidney, multiple ureteric stones, history of ureteral surgery, diabetes, gastric ulcer, usage of alpha-blocker drugs, calcium channel blocker and nitrate, pregnancy or any kind of allergy to the drugs | 132, 4 weeks | Patients in group A received tamsulosin 0.4 mg, in group B received tadalafil 10 mg, and in group C received placebo | The stone expulsion rate was 72.7% in group A, 63.6% in group B and 56.8% in group C The mean time of stone expulsion in the group A was 17.75 ± 75 days, group B was 21.13 ± 1.17 days and 22.25 ± 1.18 days in group C | Adverse effects-Group A- Headache (4.5%), orthostatic hypotension (4.5%) and retrograde ejaculation (6.8%), back pain (2.3%), dizziness (11.4%). Group B- Headache (15.9%), back pain (9.1%), dizziness (4.5%). Group C-No complications |
Furyk JS et al. [19] | RCT | Patients older than 18 years and with symptoms suggestive of ureteric colic and a calculus demonstrated in the distal ureter on computed tomography (CT) scan with a CT kidney, ureter, and bladder protocol | Temperature greater than 38° C (100.4 °F), an estimated glomerular filtration rate less than 60 mL/minute per 1.73 m2, a calculus greater than 10 mm, solitary kidney, transplanted kidney, history of ureteral structure, known allergic reaction to the study medication, or current calcium channel blocker or a-blocker use or hypotension, or if they were pregnant or planning pregnancy | 403, 28 days | Patients were allocated to 0.4 mg of tamsulosin and placebo daily for 28 days | Stone passage occurred in 87.0% of the tamsulosin patients and 81.9% of the placebo patients. The median time to stone passage was 7 days for tamsulosin and 11 days for placebo | Patients who received tamsulosin had dizziness (2%), palpitations (6%), sexual dysfunction(5.4%), headache (21.6%), fatigue (28.7%), nausea (30.3%), vomiting (9.2%), diarrhoea (10.3%), constipation(17.8%) Placebo group patients had dizziness (18.9%), palpitations (4.9%), collapse (1.1%), sexual dysfunction (2.2%), headache (29.2%), fatigue (23.8%), nausea (30.3%), vomiting, diarrhoea (10.3%), constipation (17.3%) |
Puvvada S et al. [20] | RCT | Patients aged ≥ 18 years with a ureteral stone size of 5–10 mm in its greatest dimension and situated below the common iliac vessels, as diagnosed by non-contrast computed tomography of the KUB | Patients with fever, hydronephrosis, acute or chronic renal insufficiency, multiple ureteral stones, open surgery or endoscopic interventions, diabetes, peptic ulcer or on concomitant treatment with β-blockers, calcium antagonists, or nitrates, pregnant or lactating mothers or patients who demanded immediate intervention | 207, 4 weeks | Group A were given tadalafil 10 mg once daily, and group B received tamsulosin 0.4 mg (prolonged release capsule) once daily | The stone expulsion rate was 84.0% in group A and 68.0% in group B. The mean time for stone expulsion in group A was 14.7 ± 3.8 days, and in group B was 16.8 ± 4.5 days | Adverse effects in group A- Headache (14%), dizziness (12%), backache (9%), orthostatic hypotension (8%), abnormal ejaculation (6%). Group B: Headache, backache (11%), dizziness, orthostatic hypotension (10%), abnormal ejaculation (12%) |
Kc HB et al. [21] | RCT | Patients with ureteral stones 5–10 mm in size and located in the distal ureter | Patients with urinary tract infection, severe refractory pain, severe hydronephrosis, acute or chronic renal failure, multiple ureteral stones, bilateral ureteral calculus or a single functioning kidney, any history of ureteral surgery or procedure, or urinary tract anomalies , patients receiving concomitant treatment with alpha-blockers, calcium channel blockers, nitrates, steroids, PDE5 inhibitors; patients having ischemic heart disease, congestive cardiac failure or complicated hypertension, pregnant or lactating mothers and patients who demanded urgent stone removal | 85, 2 weeks | Group A received tamsulosin 0.4 mg and group B received tadalafil 10 mg at bedtime for 2 weeks | Stone expulsion rate in the group A was (61%) and in group B was 84.01% The mean stone expulsion time was lower in group B (8.08 ± 3.3 days) than in group A (9.64 ± 3.8 days) | Adverse effects in group 1: Headache (14.6%), dizziness (12.2%), postural hypotension (9.8%), gastritis (7.3%), backache (9.8%), runny (2.4%), hearing problem (9.1%) Group B: Headache (27.3%), dizziness (18.2%), postural hypotension (15.9%), gastritis (22.7%), backache (25%), runny nose (4.5%), hearing problem (9.1%) |
Kohjimoto Y et al. [22] | RCT | Adult patients ≥ 20 years old presenting with acute renal colic, patients with a single distal ureteral stone ≤ 10 mm below the common iliac vessels in whom conservative therapy was judged to be appropriate | Presence of multiple ureteral stones, severe hydronephrosis, acute or chronic renal failure, urinary tract infection, pregnancy or breastfeeding, or serious physical disorder. Patients with a history of endoscopic or open surgical procedures for the ureter, hypersensitivity to naftopidil or flopropione, or current treatment with α- or β-blockers, anti-cholinergic drugs, calcium channel antagonists, or phosphodiesterase type 4 inhibitors or those who wished surgical treatment | 92, weekly follow-up for 28 days | Group 1 received naftopidil 75 mg once in the morning and placebo twice a day. Group 2 received flopropione 80 mg three times a day | Cumulative stone expulsion rate in naftopidil group = 77.5% and in flopropione group = 59.1% Median time to stone expulsion was 8 days for the naftopidil group and 18 days for the flopropione group | Minor adverse events were oedema in the flopropione group and nausea, diarrhoea, constipation and pruritus in the naftopidil group |
Gharib T et al. [23] | RCT | Patients aged 18 years or more, harbouring unilateral single stone 5–10 mm in largest diameter, located in the lower 1/3rd of the ureter (between the inferior border of the sacroiliac joint and ureterovesical junction) were included in the study | Patients with single kidney, urinary tract infection, bilateral or multiple stones, marked hydronephrosis, and history of previous endoscopic or open ureteral surgery | 150, 4 weeks | Group 1 patients received silodosin 8 mg and in group 2 patients received tamsulosin 0.4 mg | Stone expulsion rate in group 1 was 82.4% and in group 2 was 61.5% Mean stone expulsion time of group 1 was 9.4 ± 3.8 days and in group 2 = 12.7 ± 5.1 days | Adverse effects: Group 1-Dizziness (4.4%), postural hypotension, headache (1.47%), retrograde ejaculation (23.3%); group 2- Dizziness (6.2%), postural hypotension (3.1%), headache (1.51%), retrograde ejaculation (12.2%) |
Imperatore V et al. [24] | Retrospective observational study | Patients aged ≥ 18 years with a single, unilateral, symptomatic, radiopaque ureteric stone of 10 mm or smaller in the largest dimension located between the lower border of the sacroiliac joint and the vesico-ureteric junction as assessed on intravenous urography | Renal insufficiency, urinary tract infections, high-grade hydronephrosis. previous therapies for the stone, solitary kidney, history of ureteral surgery or previous endoscopic procedures, concomitant calcium antagonists or corticosteroids medications, ureteric strictures, cardiovascular diseases, and incomplete data | 100, weekly follow-up for 28 days | 50% of the patients received daily single dose of tamsulosin 0.4 mg for 28 days and 50% received a daily single dose of silodosin 8 mg for 28 days | Stone expulsion rate was 82% in tamsulosin group and 88% in silodosin group. Mean expulsion time for tamsulosin- 6.5 days, silodosin-6.7 days | Adverse effects in tamsulosin group- Retrograde ejaculation (2%), dizziness (8%), nasal congestion (6%), postural hypotension (6%), headache (6%) Adverse effects in silodosin- Retrograde ejaculation (16%), dizziness, nasal congestion, postural hypotension, headache (2%) |