Summary of findings 2. Transurethral microwave thermotherapy compared to sham treatment for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.
| Transurethral microwave thermotherapy compared to sham treatment for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia | |||||
| Patient or population: men with lower urinary tract symptoms due to benign prostatic hyperplasia Setting: outpatient ‐ France, USA, UK, Sweden, Netherlands Intervention: Transurethral microwave thermotherapy Comparison: Sham treatment | |||||
| Outcomes | № of participants (studies) Follow up | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
| Risk with sham treatment | Risk difference with Transurethral microwave thermotherapy | ||||
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Urologic symptom scores Assessed with: IPSS Scale from 0 (best: not at all) to 35 (worst: almost always) Follow‐up: 3 ‐ 6 months |
483 (4 RCTs) | ⊕⊕⊕⊝ MODERATEa | ‐ | The mean urologic symptom scores was 16.2 | MD 5.40 lower (6.97 lower to 3.84 lower) |
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Quality of life Assessed with: IPSS‐QoL Scale from 0 (best: delighted) to 6 (worst: terrible) Follow‐up: 6 months |
347 (2 RCTs) | ⊕⊕⊝⊝ LOWa,b | ‐ | The mean quality of life score was 3.05 | MD 0.95 lower (1.14 lower to 0.77 lower) |
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Major adverse events Assessed with: Clavien‐Dindo classification system (Grade III, IV and V complications) Follow‐up: 6 ‐ 12 months |
924 (8 RCTs) | ⊕⊝⊝⊝ VERY LOWa,c | ‐ | Six studies reported that there were no major adverse events. The two remaining studies reported four isolated cases of lesions of the urinary tract related to the procedure in both groups. | |
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Retreatment Participants requiring additional procedures or surgery Follow‐up: 6 ‐ 12 months |
82 (2 RCTs) | ⊕⊕⊝⊝ LOWa,d | RR 0.27 (0.08 to 0.88) | Study population | |
| 194 per 1000 | 141 fewer per 1000 (178 fewer to 23 fewer) | ||||
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Erectile function (sexually‐active men only) Assessed with: issues related to erectile function Follow‐up: 6 ‐ 12 months |
375 (3 RCTs) | ⊕⊝⊝⊝ VERY LOWa,c | ‐ | Two studies reported normal erections. One study reported one case of impotence. | |
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Ejaculatory function (sexually‐active men only) Assessed with: issues related to ejaculatory function Follow‐up: 6‐12 months |
727 (5 RCTs) | ⊕⊝⊝⊝ VERY LOWa,c | ‐ | Three studies reported no issues related to ejaculatory function. The two remaining studies reported isolated cases of loss of ejaculate and hematospermia. | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: mean difference; RCT: randomized controlled trial; RR: Risk ratio. | |||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. | |||||
aDowngraded by one level for study limitations: studies at an overall high risk of bias. bDowngraded by one level for imprecision: confidence interval crosses assumed threshold of minimal clinically important difference. cDowngraded by two levels for imprecision: very few events (isolated reports). dDowngraded by one level for imprecision: few events.