Bdesha 1994.
Study characteristics | ||
Methods |
Study design: prospective, randomized parallel study. Study dates: study dates not available Setting: outpatient, single center, national Country: United Kingdom |
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Participants |
Inclusion criteria: men with:
Exclusion criteria: men with:
Total number of participantsrandomized: 40 Group 1: n = 22 microwave treatment
Group 2: n = 18 sham treatment
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Interventions |
Group 1 (n = 22):TUMT LEO Microthermer was used in all participants in a single active 90‐minute treatment using a LEO Microthermer. This machine delivers a maximum power output of 20 watts at 915 MHz and incorporates an automatic power cutoff, which operates if the rectal temperature increases to greater than 42.5C. Group 2 (n = 18) sham: Same procedure, however participants received 90‐min sham treatment with no power delivered. Participants received a heating pad to simulate hyperthermia. Co‐interventions: topical lidocaine gel was used alongside flexible cystoscopy to exclude a coexisting lower urinary tract pathological condition and to measure the prostate. |
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Outcomes |
Urologic symptom scores How measured: AUA symptom score and WHO symptom score. Time points measured: baseline and 3 months Time points reported: baseline and 3 months Subgroups: none Minor and major adverse events / Erectile function / Ejaculatory function How measured: Narratively (including sexual adverse events) Time points measured: not reported Time points reported: not reported Subgroups: none Acute urinary retention How measured: not reported Time points measured: not reported Time points reported: not reported Subgroups: none Retreatment How measured: narratively (TURP after sham) 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 | Study unblinded with cross‐over at 3 months and follow‐up to 1 year. No contact information available. 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 | No information available. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. |
Allocation concealment (selection bias) | Unclear risk | The study describes only “sealed envelope.” Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. |
Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | Quote: “The patients were also asked which treatment they thought they had received: 19 of those who had received microwave treatment answered correctly, while half the patients who had received sham treatment thought they had received a real treatment.” Judgement: Participants and personnel administrating the questionnaires were blinded. |
Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Double‐blind study. Participants and study personnel were blinded (see above). |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Double‐blind study. Participants and study personnel were blinded (see above). |
Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life | Low risk | Only two participants (10%) in the sham group were lost at follow‐up. |
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events | Low risk | Only two participants (10%) in the sham group were lost at follow‐up. |
Incomplete outcome data (attrition bias) Retreatment | Low risk | Only two participants (10%) in the sham group were lost at follow‐up. |
Incomplete outcome data (attrition bias) Erectile function | Low risk | Only two participants (10%) in the sham group were lost at follow‐up. |
Incomplete outcome data (attrition bias) Ejaculatory function | Low risk | Only two participants (10%) in the sham group were lost at follow‐up. |
Incomplete outcome data (attrition bias) Acute urinary retention | Low risk | Only two participants (10%) in the sham group were lost at follow‐up. |
Incomplete outcome data (attrition bias) Indwelling catheter | Unclear risk | Only two participants (10%) in the sham group were lost at follow‐up. Not fully measured (narrative statement). |
Selective reporting (reporting bias) | Unclear risk | No protocol available. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. |
Other bias | Low risk | No other sources of bias were identified. |