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. 2018 Jan 26;2018(1):CD012551. doi: 10.1002/14651858.CD012551.pub2
Methods Study design: parallel group randomised trial.
Study dates: January 2005 to December 2010.
Setting: academic hospital.
Country: South Korea.
Participants Inclusion criteria: participants had symptoms for > 3 months, and all fulfilled the NIH diagnostic criteria for CP/CPPS.
Exclusion criteria: history of urethritis, epididymitis, varicocoele, perianal and rectal disorders, any neurological disease, presence of neurogenic bladder, urethral stricture and previous urological surgery.
Sample size: 132.
Age (years):
Group 1: 31.5 years (SD 6.7).
Group 2: 35.1 years (SD 8.9).
Group 3: 38.1 years (SD 8.0).
Baseline NIH‐CPSI score: Group 1: 26.27 (SD 5.45); Group 2: 24.59 (SD 6.51); Group 3: 23.94 (SD 5.92).
Sex: men.
Interventions Group 1 (n = 44): ciprofloxacin 500 mg twice daily and NSAIDs for 12 weeks.
Group 2 (n = 44): transrectal microwave thermotherapy alone for 12 weeks; using a Uro‐DR Device (Somang Medical; Kangreung, Korea), at an intrarectal temperature of 43 °C for 30 min, at a medium heating rate.
Group 3 (n = 44): transrectal microwave thermotherapy in combination with the treatment in group 1 for 12 weeks.
Outcomes Prostatitis symptoms
How measured: NIH‐CPSI score.
Time points measured: baseline, and 4, 8 and 12 weeks.
Time points reported: baseline and 12 weeks.
Adverse events
How measured: narratively.
Funding sources Not available.
Declarations of interest No potential conflict of interest relevant to this article reported.
Notes These characteristics were completed with the collaboration of the author Dr Chung (chunghong@kku.ac.kr) who provided the manuscript accepted for publication and additional information (see 'Risk of bias' table).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random sequence generated with an Excel spreadsheet (information provided by author).
Allocation concealment (selection bias) High risk Allocation not concealed (information provided by author).
Blinding of participants and personnel (performance bias) Subjective outcomes High risk Open label study.
Blinding of outcome assessment (detection bias) All outcomes High risk Open label study.
Incomplete outcome data (attrition bias) All outcomes High risk Unbalanced attrition: missing outcome data (all outcomes) in 7/44 participants in Group 1, 3/44 participants in Group 2, 9/44 participants in Group 3.
Selective reporting (reporting bias) Unclear risk No protocol available.
Other bias Low risk No other sources of bias identified.