Microwave thermotherapy for benign prostatic hyperplasia

Richard M Hoffman; Manoj Monga; Sean P Elliott; Roderick MacDonald; Jens Langsjoen; James Tacklind; Timothy J Wilt

doi:10.1002/14651858.CD004135.pub3

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Figure 1

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 1 International Prostate Symptom Score (IPSS): 6 mos ‐ 1 year follow‐up.

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Analysis 1.2

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 2 Madsen‐Iversen Symptom Score (range 0 to 27): 6 mos ‐ 1 year follow‐up.

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Analysis 1.3

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 3 50% Improvement in AUA Symptom Score: # subjects.

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Analysis 1.4

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 4 Peak Flow Rate (Qmax): 6 mos ‐ 1 year follow‐up.

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Analysis 1.5

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 5 Hematuria (requiring additional treatment/judged to be serious).

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Analysis 1.6

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 6 Urinary retention.

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Analysis 1.7

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 7 Dysuria/Urgency.

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Analysis 1.8

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 8 Urinary tract infections/epididymitis/orchitis.

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Analysis 1.9

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 9 Retrograde ejaculation (sexually active men only).

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Analysis 1.10

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 10 Erectile dysfunction.

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Analysis 1.11

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 11 Repeat treatments/Reoperations up to 1 year.

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Analysis 1.12

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 12 Urethral/bladder neck strictures.

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Analysis 1.13

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 13 Transfusions.

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Analysis 1.14

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 14 Clot retention.

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Analysis 1.15

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 15 TURP Syndrome.

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Analysis 2.1

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 1 International Prostate Symptom Score (IPSS).

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Analysis 2.2

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 2 Madsen Symptom Score.

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Analysis 2.3

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 3 Peak Flow Rate (Qmax).

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Analysis 2.4

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 4 Hematuria (post‐procedure).

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Analysis 2.5

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 5 Urinary retention.

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Analysis 2.6

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 6 Dysuria (self‐limited).

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Analysis 2.7

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 7 UTI/epididymitis.

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Analysis 2.8

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 8 Ejaculatory disorders.

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Analysis 2.9

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 9 Retreatment.

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Analysis 2.10

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 10 Quality of Life.

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Analysis 2.11

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 11 Bladder spasm.

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Transurethral microwave thermotherapy (TUMT) compared with transurethral resection of the prostate (TURP) for symptomatic benign prostatic hyperplasia
Patient or population: men with symptomatic benign prostatic hyperplasia Settings: office (TUMT) or hospital (TURP) Intervention: Transurethral microwave thermotherapy (TUMT) Comparison: Transurethral resection of the prostate (TURP)
Outcomes	*Illustrative comparative risks (95% CI)**		No of Participants (studies)	Quality of the evidence (GRADE)
	Assumed risk	Corresponding risk
	TURP	TUMT
International Prostate Symptom Score (IPSS). Range: 0 to 35 points. Follow‐up: 6 mos ‐ 1 year	The mean IPSS scores ranged across control groups from 3.4 to 7.1 points	The mean IPSS in the intervention group was 1 point higher (95% CI, 0.03 lower to 2.03 higher)	306 (studies)	⊕⊕⊕⊝ moderate¹
Madsen‐Iversen Symptom Score Range 0 to 27 points Follow‐up: 6 mos ‐ 1 year	The mean Madsen‐Iversen Symptom scores ranged across control groups from 0.62 to 2.7 points	The mean Madsen‐Iversen Symptom score in the intervention group was 1.59 points higher (95% CI, 0.69 lower to 2.48 higher)	338 (5 studies)	⊕⊕⊕⊝ moderate¹
Peak Flow Rate (Qmax): Measurement: mL per second Follow‐up: 6 mos ‐ 1 year	The mean Peak Flow Rate ranged across control groups from 14.6 to 20.6 mL/s	The mean urinary peak flow rate in the intervention group was 5.08 mL/s lower (95% CI, 3.88 to 6.28 lower)	108 (2 studies)	⊕⊕⊕⊝ moderate¹
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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; RR: Risk Ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ <400 subjects evaluated for this outcome which is a non‐optimal information size

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Comparison 1. Microwave thermotherapy versus transurethral resection of the prostate (TURP)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 International Prostate Symptom Score (IPSS): 6 mos ‐ 1 year follow‐up Show forest plot	4	306	Mean Difference (IV, Random, 95% CI)	1.00 [‐2.03, 0.03]

1.1 ProstaLund Feedback Treatment	1	136	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐2.44, 2.24]
1.2 Prostatron (high‐energy Prostasoft 2.5)	2	104	Mean Difference (IV, Random, 95% CI)	‐0.95 [‐2.40, 0.51]
1.3 Prostatron (Prostasoft 2.0 and 2.5)	1	66	Mean Difference (IV, Random, 95% CI)	‐2.7 [‐5.87, 0.47]
2 Madsen‐Iversen Symptom Score (range 0 to 27): 6 mos ‐ 1 year follow‐up Show forest plot	2	108	Mean Difference (IV, Fixed, 95% CI)	1.59 [0.69, 2.48]

2.1 Prostatron (high‐energy Prostasoft 2.5)	1	44	Mean Difference (IV, Fixed, 95% CI)	1.5 [‐1.07, 4.07]
2.2 Prostatron (low‐energy Prostasoft 2.0)	1	64	Mean Difference (IV, Fixed, 95% CI)	1.6 [0.64, 2.56]
3 50% Improvement in AUA Symptom Score: # subjects Show forest plot	2	121	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.50, 1.09]

4 Peak Flow Rate (Qmax): 6 mos ‐ 1 year follow‐up Show forest plot	5	338	Mean Difference (IV, Fixed, 95% CI)	5.08 [3.88, 6.28]

4.1 ProstaLund Feedback Treatment	1	104	Mean Difference (IV, Fixed, 95% CI)	1.90 [‐1.17, 4.97]
4.2 Prostatron (high‐energy Prostasoft 2.5)	2	104	Mean Difference (IV, Fixed, 95% CI)	5.26 [3.67, 6.85]
4.3 Prostatron (low‐energy Prostasoft 2.0)	1	64	Mean Difference (IV, Fixed, 95% CI)	6.30 [3.80, 8.80]
4.4 Prostatron (Prostasoft 2.0 and 2.5)	1	66	Mean Difference (IV, Fixed, 95% CI)	7.40 [1.68, 13.12]
5 Hematuria (requiring additional treatment/judged to be serious) Show forest plot	3	258	Risk Difference (M‐H, Random, 95% CI)	‐0.05 [‐0.15, 0.05]

6 Urinary retention Show forest plot	4	343	Risk Ratio (M‐H, Fixed, 95% CI)	2.94 [1.52, 5.70]

7 Dysuria/Urgency Show forest plot	3	277	Risk Ratio (M‐H, Fixed, 95% CI)	2.22 [1.28, 3.86]

8 Urinary tract infections/epididymitis/orchitis Show forest plot	5	395	Risk Ratio (M‐H, Fixed, 95% CI)	1.15 [0.70, 1.86]

9 Retrograde ejaculation (sexually active men only) Show forest plot	2	78	Risk Difference (M‐H, Fixed, 95% CI)	‐0.34 [‐0.55, ‐0.13]

10 Erectile dysfunction Show forest plot	3	212	Risk Ratio (M‐H, Fixed, 95% CI)	0.41 [0.16, 1.05]

11 Repeat treatments/Reoperations up to 1 year Show forest plot	4	335	Risk Ratio (M‐H, Fixed, 95% CI)	1.76 [0.54, 5.70]

12 Urethral/bladder neck strictures Show forest plot	3	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.13 [0.02, 0.71]

13 Transfusions Show forest plot	2	128	Risk Difference (M‐H, Fixed, 95% CI)	‐0.11 [‐0.21, ‐0.02]

14 Clot retention Show forest plot	3	283	Risk Ratio (M‐H, Fixed, 95% CI)	0.27 [0.06, 1.31]

15 TURP Syndrome Show forest plot	3	274	Risk Difference (M‐H, Fixed, 95% CI)	‐0.05 [‐0.11, ‐0.00]

Comparison 1. Microwave thermotherapy versus transurethral resection of the prostate (TURP)

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Comparison 2. Microwave thermotherapy versus sham treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 International Prostate Symptom Score (IPSS) Show forest plot	4	482	Mean Difference (IV, Fixed, 95% CI)	‐5.15 [‐6.04, ‐4.26]

1.1 LEO Microthermer: 3 months follow‐up	1	40	Mean Difference (IV, Fixed, 95% CI)	‐9.1 [‐15.64, ‐2.56]
1.2 Prostatron (Prostasoft 2.0): 3/6 months follow‐up	1	94	Mean Difference (IV, Fixed, 95% CI)	‐5.0 [‐8.09, ‐1.91]
1.3 Dornier Urowave: 6 months follow‐up	1	193	Mean Difference (IV, Fixed, 95% CI)	‐5.30 [‐6.32, ‐4.28]
1.4 Urologix Targis system: 6 months follow‐up	1	155	Mean Difference (IV, Fixed, 95% CI)	‐3.80 [‐6.26, ‐1.34]
2 Madsen Symptom Score Show forest plot	2	196	Mean Difference (IV, Fixed, 95% CI)	‐5.10 [‐6.42, ‐3.79]

2.1 Prostatron (Prostasoft): 3 months follow‐up	1	108	Mean Difference (IV, Fixed, 95% CI)	‐4.50 [‐6.37, ‐2.63]
2.2 Prostatron (Prostasoft 2.0): 3 months follow‐up	1	88	Mean Difference (IV, Fixed, 95% CI)	‐5.7 [‐7.56, ‐3.84]
3 Peak Flow Rate (Qmax) Show forest plot	6	643	Mean Difference (IV, Random, 95% CI)	2.01 [0.85, 3.16]

3.1 LEO Microthermer: 3 months follow‐up	1	40	Mean Difference (IV, Random, 95% CI)	4.80 [1.98, 7.62]
3.2 Prostatron (Prostasoft): 3 months follow‐up	1	108	Mean Difference (IV, Random, 95% CI)	2.10 [0.56, 3.64]
3.3 Prostatron (Prostasoft 2.0): 3/6 months follow‐up	2	168	Mean Difference (IV, Random, 95% CI)	1.94 [‐1.29, 5.16]
3.4 Dornier Urowave: 6 months follow‐up	1	195	Mean Difference (IV, Random, 95% CI)	0.90 [‐0.45, 2.25]
3.5 Urologix Targis system: 6 months follow‐up	1	132	Mean Difference (IV, Random, 95% CI)	2.0 [0.14, 3.86]
4 Hematuria (post‐procedure) Show forest plot	4	684	Risk Difference (M‐H, Fixed, 95% CI)	0.07 [0.01, 0.13]

5 Urinary retention Show forest plot	7	812	Risk Ratio (M‐H, Fixed, 95% CI)	6.04 [2.51, 14.52]

6 Dysuria (self‐limited) Show forest plot	2	403	Risk Ratio (M‐H, Fixed, 95% CI)	2.06 [1.03, 4.13]

7 UTI/epididymitis Show forest plot	3	486	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.70, 2.39]

8 Ejaculatory disorders Show forest plot	2	389	Risk Ratio (M‐H, Fixed, 95% CI)	6.10 [0.83, 45.08]

9 Retreatment Show forest plot	2	209	Risk Ratio (M‐H, Fixed, 95% CI)	0.12 [0.03, 0.48]

10 Quality of Life Show forest plot	2	347	Mean Difference (IV, Fixed, 95% CI)	‐0.95 [‐1.14, ‐0.77]

11 Bladder spasm Show forest plot	3	443	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.71, 1.47]

Comparison 2. Microwave thermotherapy versus sham treatment

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