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. 2018 Jan 26;2018(1):CD012551. doi: 10.1002/14651858.CD012551.pub2
Methods Study design: parallel group randomised trial (3:1 allocation ratio).
Study dates: February 1998 to May 2001.
Setting: national, multicentre.
Country: Finland.
Participants Inclusion criteria: moderate‐to‐severe symptoms of CPPS; > 6 months of CPPS symptoms.
Exclusion criteria: bacterial prostatitis, prostate cancer, excessive prostatic hyperplasia and any other abnormality that would affect study.
Sample size: 33.
Age (years): Group 1: mean 42.8 (range 36‐55); Group 2: mean 49.8 (range 45‐53).
Baseline NIH‐CPSI score: PSSI score: Group 1: mean 37.3 (SD 16.4); Group 2: mean 33.6 (SD 18.1).
Sex: men.
Interventions Group 1 (n = 25): TUNA. 'The TUNA procedures were done using 465‐kHz radiofrequency energy and the formal needle insertion technique as described by Issa 1996. Treatment was applied on two planes on both lateral lobes of the prostate in all patients so that the target temperature of 50°C at the needle tip was achieved for at least 1 minute.'
Group 2 (n = 8): sham urethroscopy preformed so it was seemingly identical to TUNA intervention in participant's view.
Cointerventions: both interventions were done under spinal analgesia and light intravenous sedation. A single‐dose of intravenous tobramycin 160 mg used as antibiotic prophylaxis prior to interventions in all cases. Study participants were allowed to use ketoprofen as analgesic during follow‐up with responsibility to keep record of drug intake.
Outcomes Prostatitis symptoms
How measured: PSSI.
Time points measured: 3, 6 and 12 months.
Time points reported: baseline and 12 months (other time points presented graphically).
Urinary symptoms
How measured: IPSS.
Time points measured: 3, 6 and 12 months.
Time points reported: baseline, and 3, 6 and 12 months.
Adverse events
How measured: narratively.
Funding sources None.
Declarations of interest None.
Notes None.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: 'Patients... were randomized according to the closed‐envelope method at a 3:1 ratio to either TUNA treatment (n=25) or urethrocystoscopy as sham treatment (n=8).' No additional information provided.
Allocation concealment (selection bias) Unclear risk No information available.
Blinding of participants and personnel (performance bias) Subjective outcomes Unclear risk Quote: 'The patients were not told whether they received TUNA or sham treatment, and to the patients’ eyes, both procedures were designed to seem externally alike. The TUNA equipment was visibly present in the operating room during the sham procedures, and the cystoscope was left in the prostatic urethra for 20 min to mimic the TUNA procedure as closely as possible.'
Considering the methodology, blinding of the participants was likely to have been successful. But, since there was no information regarding blinding of other key study personnel, the judgement of risk of performance bias remained unclear.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No information provided.
Incomplete outcome data (attrition bias) All outcomes Low risk All outcomes: outcome data available for all randomised participants.
Selective reporting (reporting bias) Unclear risk Insufficient information for judgement.
Other bias Unclear risk Baseline differences suggested that groups might not be comparable in terms of duration of symptoms, but small sample size and 3:1 allocation ratio could account for random differences.