Dahlstrand 1995.
Study characteristics | ||
Methods |
Study design: parallel‐group randomized trial Study dates: study dates not available Setting: outpatient (TUMT), inpatient (TURP), single‐center, national Country: Sweden |
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Participants |
Inclusion criteria: men:
Exclusion criteria:
Total number of participants randomized: 93 Group 1 (n = 46) TUMT
Group 2 (n = 47) TURP
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Interventions |
Group 1 (n = 39): TUMT 1‐hour treatment in a single session performed by a single physician using the Prostatron (Technomed International, France) only with topical anesthesia and oral analgesia. The urethral catheter delivered up to 60 W of microwave energy and monitored temperature (as well as the rectal probe) through software. The urethral temperature could reach a maximum temperature of 44.5 °C and the rectal temperature could reach a maximum temperature of 42.5 °C. Postoperatively oral norfloxacin 400 mg twice a day was administered for 5 days. An indwelling urethral catheter was left in place for 3 ‐ 5 days if the participant was unable to void after treatment Group 2 (n = 44): TURP Urologists who were at the level of senior registrar or above resected the prostate, using resectoscopes with a Charrière of 24 ‐ 28, down to the surgical capsule circumferentially and extended from the bladder neck to the verumontanum Co‐interventions: not reported. |
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Outcomes |
Urologic symptom scores How measured: Madsen symptom score Time points measured: baseline, 2, 3, 6, 12 months, 2 years Time points reported: baseline, 2, 3, 6, 12 months, 2 years Subgroups: none Major and minor adverse events (including erectile and ejaculatory function) How measured: not reported Time points measured: not reported Time points reported: not reported Subgroups: none Retreatment How measured: number of participants that required another session of TUMT or TURP Time points measured: not reported Time points reported: not reported Subgroups: none Indwelling urinary catheter How measured: number of participants that required catheterization after the procedure. Time points measured: not reported Time points reported: not reported Subgroups: none Relevant outcomes not reported in this study
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Funding sources | Not available | |
Declarations of interest | Not available | |
Notes | There are 2 reports of this study by the same authors. In the first report there are 83 randomized participants, whereas in the second report there are 72. We accounted this as attrition. Email for the contact author was not available, so we wrote to his coauthor Dr. Fall (magnus.fall@urology.gu.se) for details, but he did not have this information. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “patients were recruited for the study and blindly randomised.” Comment: Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’. We wrote to study authors. |
Allocation concealment (selection bias) | Unclear risk | Quote: “patients were recruited for the study and blindly randomised.” Comment: Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’. We wrote to study authors. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | While blinding was not mentioned, the interventions were visibly different (surgery versus outpatient procedure). |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | While blinding was not mentioned, the interventions were visibly different (surgery versus outpatient procedure). Comment: The objective outcomes were unlikely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | While blinding was not mentioned, the interventions were visibly different (surgery versus outpatient procedure). Comment: The subjective outcomes were likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 12‐month follow‐up, 78 participants (93%) had available data (first report). Quote: “Four patients were excluded; 1 patient because he contracted severe hepatitis while abroad precluding follow‐up; 2 patients because cancer was discovered at the time of histological examination of the TUR specimen requiring orchiectomy, and 1 patient who refused randomizations to TURP.” Judgment (12 months): low risk of bias. 2‐year follow‐up, 61 participants (73%) had available data (second report). Quote: “All patients were followed for 2 years but in 10 patients the follow‐up was incomplete. In the TURP group, one patient died from a brain tumour after his 6‐month follow‐up. At the 2‐year follow‐up, one patient underwent an operation for a lumbar disc hernia and was unavailable. In the TUMT group, one patient was abroad at the 3‐month follow‐up and after the 6‐month follow‐up, two patients had a TURP and were excluded from the study, one patient refused further follow‐up and another suffered severe pancreatitis which precluded that visit. Two patients who had undergone a second TUMT after the 6‐month follow‐up took part in the 1‐year follow‐up but had not improved and, after undergoing TURP, they were excluded before the 2‐year follow‐up. One patient was disabled due to severe neurological disease after the 1‐year follow‐up.” Judgment (2 years): high risk of bias. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’. We wrote to study authors. |
Other bias | Low risk | No other sources of bias were identified. |