Methods |
Study design: parallel group randomised trial. Study dates: January 2005 to December 2010. Setting: academic hospital. Country: South Korea. |
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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. |
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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. |
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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. |
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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. |