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:
Exclusion criteria:
Total number of participantsrandomized: 93 Group 1 (n = 46) TUMT
Group 2 (n = 47) TURP
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Interventions |
Group 1 (n = 39): TUMT One‐hour treatment in a single session performed by a single physician using the Prostatron (Technomed International, France) only with topical anaesthesia and oral analgesia. The urethral catheter delivered up to 60 W of microwave energy and monitored temperature (as well as the rectal probe) through a 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 placed and left in place for 3‐5 days if the patient 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 dysfunction) 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/Acute urinary retention How measured: number of patients 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 two 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 and he did not have this information. Protocol: not available Language of publication: English |
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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 randomized.” Insufficient information to permit judgement 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 randomized.” Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. We wrote to study authors. |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Whereas blinding was not mentioned, the interventions were visibly different (surgery versus outpatient procedure). The subjective outcomes were likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Whereas blinding was not mentioned, the interventions were visibly different (surgery versus outpatient procedure). The subjective outcomes were likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Whereas blinding was not mentioned, the interventions were visibly different (surgery versus outpatient procedure). The objective outcomes were unlikely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life | 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 randomisation to TURP.” Judgement (12 months): low risk of bias (main judgement). 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.” Judgement (2 years): high risk of bias (long‐term data). |
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events | Low risk | See above (main judgement). |
Incomplete outcome data (attrition bias) Retreatment | High risk | See above (long‐term judgement). |
Incomplete outcome data (attrition bias) Erectile function | Low risk | See above (main judgement). |
Incomplete outcome data (attrition bias) Ejaculatory function | Low risk | See above (main judgement). |
Incomplete outcome data (attrition bias) Acute urinary retention | Low risk | See above (main judgement). |
Incomplete outcome data (attrition bias) Indwelling catheter | Unclear risk | Not fully measured (narrative statement). |
Selective reporting (reporting bias) | Low risk | No protocol available. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. We wrote to study authors. |
Other bias | Low risk | No other sources of bias were identified. |