Methods |
Study design: parallel group randomised trial. Study dates: study dates not available. Setting: outpatient, national. Country: Russia. |
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Participants |
Inclusion criteria: men aged 20‐50 years; diagnosis of chronic abacterial prostatitis registered > 1 year ago at time of enrolment, pain in pelvic area and lower abdominal pain; presence of urinary symptoms; altered structure of prostate as assessed by rectal examination. Exclusion criteria: not available. Sample size: 37. Age (years): overall range 20‐50 years. NIH‐CPSI baseline score: not available. Sex: men. |
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Interventions |
Group 1 (n = 17): medical therapy alone (see cointerventions). Group 2 (n = 20): breathing exercises using "Karbonik" apparatus (hypercapnic hypoxia) 10‐20 min daily for 10 days. Cointerventions: levofloxacin 500 mg/day for 10 days, tamsulosin 0.4 mg once daily for 10 days, Serenoa repens fructuum extract 1 capsule once daily, Nimesulide 1‐2 tablets daily for 5‐7 days, Samprost rectal suppositories once daily before bedtime for 10 days. |
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Outcomes |
Urinary symptoms How measured: IPSS. Time points measured: baseline and 10 days (end of treatment). Time points reported: baseline and 10 days (end of treatment). |
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Funding sources | None. | |
Declarations of interest | None. | |
Notes | The active treatment apparatus invention and its patent belonged to the institution that conducted the trial (Altai State Medical University). Article in Russian. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information available to make a judgement. |
Allocation concealment (selection bias) | Unclear risk | No information available to make a judgement. |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | No information available to make a judgement. Considering the visibly different interventions, blinding was unlikely. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No information available to make a judgement. Considering the visibly different interventions, blinding was unlikely. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes: outcome data available for all participants. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Unclear risk | Baseline characteristics poorly reported. |