| Methods |
Study design: parallel‐group randomised controlled trial. Setting: multicentre (number not stated)/Turkey. Dates when study was conducted: not specified. |
|
| Participants |
Inclusion criteria: single radio‐opaque lower ureteral stone. Exclusion criteria: ureteral and/or bladder surgery, anatomic urinary system abnormality, vesicouretral reflux, neurogenic/non‐urogenic voiding dysfunction, bilateral or non‐opaque renal stones, severe hydronephrosis, colic pain attacks, and the use of diuretic and/or calcium channel blockers. Diagnostic criteria: KUB and US or NCCT. Total number of participants randomly assigned: 50 (45 completed the study). Group A (doxazosin)
Group B (ibuprofen only)
|
|
| Interventions |
Group A (n = 24): 0.03 mg/kg/d doxazosin once daily before bed plus the above dose of ibuprofen. Group B (n = 21): ibuprofen 20 mg/kg/d divided into 2 equal doses. No placebo. Co‐interventions: none. |
|
| Outcomes |
Stone clearance
|
|
| Notes |
Funding Sources: authors declare no relevant financial interests. Declaration of interests: not stated. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was performed using the permuted block method in MedCalc, version 11.5.1, program for the 50 participants. |
| Allocation concealment (selection bias) | Unclear risk | Concealment not detailed. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote from publication: 'absence of placebo and therefore absence of blinding were additional limitations'. Described as a limitation by authors. |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Quote from publication: 'absence of placebo and therefore absence of blinding were additional limitations'. Described as a limitation by authors. |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Objective outcomes are not likely to be influenced by lack of blinding. |
| Incomplete outcome data (attrition bias) Stone free rate | High risk | 1/25 (4.0%) and 4/25 (16.0%) participants in doxazosin and ibuprofen group were not included in the analysis, respectively. Adherence of participants are not balanced across intervention groups. |
| Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment | Unclear risk | Participants with adverse events were excluded in analysis. |
| Incomplete outcome data (attrition bias) Secondary procedures | Unclear risk | No information given. |
| Incomplete outcome data (attrition bias) Hospital stay | Unclear risk | No information given. |
| Incomplete outcome data (attrition bias) Pain | High risk | 1/25 (4.0%) and 4/25 (16.0%) participants in doxazosin and ibuprofen group were not included in the analysis, respectively. Adherence of participants are not balanced across intervention groups. |
| Selective reporting (reporting bias) | High risk | Patients with adverse events were excluded in analysis and no published protocol available. |
| Other bias | Low risk | Not detected. |