Background
Method
Selection of studies
Quality assessment
Data analysis
Results
A. Non-comparative studies
Characteristics | Mean (range) | Frequency studies/patients (%) |
---|---|---|
Sample size
| 59 (range:10–206) | |
Age (years)
| 67.5 ± 2.9 (47–90) | |
Follow-up (months) [n]
| 16 ± 15 (1–63) | |
Continent
| ||
Europe | 13 (50%) | |
America | 6 (23%) | |
Asia | 3 (11.5%) | |
Australia | 3 (11.5%) | |
Africa | 1 (4%) | |
Studies in languages other than English
| 3 (11.5%) | |
Type of study
| ||
Design | ||
Prospective | 24 (92%) | |
Retrospective | 1 (4%) | |
Unknown | 1 (4%) | |
Single-center | 17 (65.4%) | |
Multicenter | 9 (34.6%) | |
Type of anesthesia
| ||
Local | 3 (13%) | |
Local+sedation | 10 (43.5%) | |
Spinal | 3 (13%) | |
General | 2 (8.7%) | |
General/local+sedation | 5 (22%) | |
Variables assessed
| ||
Symptoms | 25 (96.2%) | |
Quality of life score | 22 (84.6%) | |
Qmax (mL/s) | 25 (96.2%) | |
PVR (mL) | 17 (65.4%) | |
Sexual function | 12 (46.2%) | |
Pressure-flow studies | 7 (26.9%) | |
Prostatic size | 13 (50%) | |
Re-treatment | 17 (65.4%) | |
Adverse effects | 22 (84.6%) | |
Duration of procedure | 15 (57.7%) | |
Hospital stay | 11 (42.3%) | |
Quality assessment
| ||
Consecutive or representative sample | Yes: 21 No: 3 Not reported:2 | |
Presence of cointerventions | Yes: 19 No: 1 Not reported:6 | |
Evaluation blind or independent | Yes: 0 No: 26 Not reported:0 | |
Losses to follow-up ≥ 20% | Yes:11 No:9 Not reported:6 |
Efficacy
3 months | 6 months | 1 year | 2 years | 3 years | 4 years | 5 years | |
---|---|---|---|---|---|---|---|
Symptom index
| |||||||
Studies | 1426,28–30,32,33,35,36,38,43,45–48
| 1425,26,28–30,32,33,35,36,38,39,41,43,45
| 1330,32–36,38,39,41,43–45, 47
| 432,36,43,44
| 242,44
| 144
| 244,49
|
No. patients | 650 | 661 | 868 | 403 | 297 | 206 | 394 |
Effect | -11.33 | -12.52 | -12.59 | -12.98 | -9.94 | -10.2 | -10.99 |
95% CI | -14.1,-8.6 | -15, -9.9 | -14, -11.4 | -14.2,- 11.8 | -10, -9 | -11,-9. | -14,- 8.3 |
P-value | .000 | .000 | .000 | .000 | .000 | .000 | .000 |
%improvement | 53% | 59% | 59% | 61% | 47% | 48% | 51% |
Quality-of-life score
| |||||||
Studies | 1226,28,30,32,33,35,36,38,43,45,47,48
| 1325,26,28,30,32,33,35,36,38,39,41,43,45
| 1430,32–36,38,39,41,43–47
| 532,36,43,44,46
| 144
| 144
| 244,49
|
No. patients | 545 | 646 | 959 | 496 | 206 | 206 | 394 |
Effect | -2.80 | -2.79 | -2.60 | -2.51 | -2.1 | -1.9 | -2.14 |
95% CI | -3.3, -2.3 | -3.2,-2.4 | -3, -2.15 | -2.8, -2.23 | ‡ | ‡ | -3.2, -1. |
P-value | .000 | .000 | .000 | .000 | ‡ | ‡ | .000 |
%improvement | 60% | 60% | 56% | 54% | 45% | 41% | 46% |
Qmax (mL/s)
| |||||||
Studies | 1525,26,28–30,33,35–38,43,45–48
| 1725,26,28–30,32–39,41,43,45,46
| 1430,32–36,38,39,41,43–47
| 432,36,43,44
| 242,44
| 144
| 244,49
|
No. patients | 578 | 817 | 960 | 403 | 297 | 206 | 394 |
Effect | 5.381 | 5.32 | 4.40 | 5.029 | 3.48 | 4.10 | 3.53 |
95% CI | 3.67,7.08 | 3.7, 6.9 | 2.94, 5.86 | 4.35, 5.7 | 1.5, 5.4 | 3.2, 4.9 | 2.9, 4.2 |
P-value | .000 | .000 | .000 | .000 | .001 | .000 | .000 |
%improvement | 33% | 34% | 45% | 37% | 57% | 49% | 56% |
PVR (mL)
| |||||||
Studies | 1128,29,33,35–38,43,45,47,48
| 1028,29,33,35,36,38,39,43,45,46
| 1033–36,38,39,43,45,47
| 245,52
| NA | NA | 149
|
No. patients | 440 | 557 | 598 | 77 | 188 | ||
Effect | -29.55 | -37.6 | -32.10 | -29.5 | -58 | ||
95% CI | -38.9, -20 | -49.7,-25.5 | -44,-20 | -47.5,- 11.5 | -76,-40 | ||
P-value | .000 | .000 | .000 | .001 | .000 | ||
%improvement | 28% | 36% | 31% | 28% | 56% | ||
P
det
at Qmax (cm H
2
O)
| |||||||
Studies | 332,35,36
| 726,29,30,32,35–37
| 232,36
| 232,36
| NA | NA | NA |
No. patients | 238 | 247 | 167 | 167 | |||
Effect | -24.64 | -25.36 | -22.74 | -24.48 | |||
95% CI | -35.6,-13.6 | -33.2,-17.5 | -29.5, -16 | -40, -8.92 | |||
P-value | .000 | .000 | .000 | .002 | |||
%improvement | 28% | 29% | 25% | 28% | |||
Prostatic size
| |||||||
Studies | 726,28,31,33,35,43,48
| 529,33,41,43,46
| 430,33,43,46
| 143
| NA | NA | 149
|
No. patients | 242 | 257 | 140 | 8 | 131 | ||
Effect | -6.32 | -6.45 | -7.89 | -7.9 | 1.9 | ||
95% CI | -9.1,-3.5 | -9.6,-3.3 | -10.6,-5.1 | -17.7,1.9 | -3.4,7.2 | ||
P-value | .00 | .00 | .00 | .11 | .48 | ||
% reduction | 14% | 14% | 17% | 17% | 0% |
Safety
Adverse effect | No. events | Percentage of total patients |
---|---|---|
Hematuria: | ||
- Mild | 337 | 28% |
- Moderate | 85 | 7% |
- Transitory unspecified severity | 25 | 2% |
- Severe | 16 | 1% |
Transitory urinary retention | 279 | 23% |
Dysuria | 167 | 14% |
Irritative symptoms | 117 | 10% |
Urinary tract infection | 43 | 4% |
Pain during procedure | ||
Moderate | 11 | 0.9% |
Intense | 4 | 0.3% |
Postoperative perineal pain | 13 | 1% |
Epidydimo-orchitis | 11 | 0.9% |
Mild-moderate burning sensation | 10 | 0.8% |
High fever | 8 | 0.7% |
Treatment halted due to intolerance to procedure | 6 | 0.5% |
Urethral stenosis | 6 | 0.5% |
Erectile dysfunction | 4 | 0.3% |
Hemospermia | 4 | 0.3% |
Retrograde ejaculation | 3 | 0.2% |
Loss of ejaculation | 1 | 0.08% |
Prostatism | 2 | 0.2% |
Complex bladder dysfunction | 1 | 0.08% |
Damage in the mucosa | 1 | 0.08% |
Deep vein thrombosis | 1 | 0.08% |
Use of healthcare resources
B. Comparative studies
Author [reference number] | ||||||||
---|---|---|---|---|---|---|---|---|
Bruskewitz [50] | Roehrborn [51] | Chandrasekar [52] | Cimentepe [53] | Hill [54] | Schatzl [55,57] | Arai [56] | Minardi [58] | |
Design
| RCT | RCT | RCT | RCT | RCT | Prospective cohort | Prospective cohort | Prospective cohort |
No. patients
| 121 | 121 | 156 | 59 | 121 | 95 | 204 | 212 |
TUNA [N. patients]
| 65 | 65 | 76 | 26 | 65 | 15 | 51 | 24 |
Comparator [No. Patients]
| TURP [56] | TURP [56] | TURP [76] | TURP [33] | TURP [56] | TURP [28] TUVP [17] VLAP [15] HIFU [20] | TURP [65] TUMT [40] ILC[48] | TURP [90] TUVP [13] ILC[71] WIT [13] |
Duration of symptoms
| > 3months | > 3months | Not reported | Not reported | > 3months | Not reported | Not reported | Not reported |
Anesthesia
| TUNA: Local TURP: General | TUNA: Local TURP: General | Not reported | Regional | TUNA: Local TURP: General | General/Regional | TUNA, ILC: Not reported TURP: Spinal TUMT: Local | TUNA-WIT:Local TUVP, ILC: Spinal TURP: General |
Variables assessed
| Symptom, QoL, Qmax, PVR, prostatic size, adverse effects duration of procedure, hospital stay | Pdetat Qmax No. Abrams-Griffiths | Symptom, QoL, Qmax, adverse effects, hospital stay, re-treatment | Symptom, QoL, Qmax, PVR, sexual function, prostatic size, adverse effects, duration of procedure, hospital stay, re-treatment | Symptom, QoL, Qmax, PVR, adverse effects, hospital stay, re-treatment | Symptom, QoL, Qmax, PVR, adverse effects, hospital stay, re-treatment | Symptom, QoL, Qmax, PVR, sexual function, adverse effects. | Symptom, QoL, Qmax, PVR, Pdet at Qmax, prostatic size, adverse effects, duration, re-treatment |
Follow-up
| 12 months | 6 months | 7 years | 18 months | 5 years | 6 weeks/24 m | 3 months | 24 months |
Randomization method specified
| Yes | Yes | No | No | Not applicable | Not applicable | Not applicable | |
Inclusion/exclusion criteria specified
| Yes | Yes | No | Yes | Yes | Yes | Yes | |
Concomitant treatment specified
| Yes | Yes | No | Yes | Yes | No | No | |
Intention-to-treat analysis
| Yes | Yes | Not reported | Not reported | Yes | Not reported | Not reported | |
Blind/Independent evaluation
| Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | |
Losses
| TUNA:9% TURP:16% | None | Not reported | None | TUNA>72% TURP > 60% | TUVP [4] VLAP [4] HIFU [4] TUNA [3] | TUNA [9] TURP [10] TUMT [6], ILC [6] | Not reported |
1. TUNA vs. TURP
Clinical efficacy
Variable | Studies (No. patients) | TUNA Difference in means (% improvement) | TURP Difference in means (% improvement) | TUNA vs. TURP Difference in means (95% CI), P value |
---|---|---|---|---|
Symptom score
| ||||
3 months | 350,53,56 (384) | -12.49 (57%) | -13.85 (64 %) | 1.33 (-.81,3.47), .22 |
1 year | 452–54,57 (427) | -12.09 (55%) | -15.48 (71%) | 3.69 (2.09, 5.29), .00 |
2 years | 352,54,57 (368) | -10.42 (48%) | -14.83 (68%) | 4.72 (3.77, 5.69), .00 |
3 years | 252,54 (273) | -9.83 (45%) | -14.63 (67%) | 4.82 (4.25, 5.39), .00 |
4 years | 154 (121) | -10.80 (50%) | -16.50 (76%) | 5.70 (4.67, 6.73), .00 |
5 years | 154 (121) | -13.30 (61%) | -13.30 (61%) | 0 (-0.99, 0.99), 1.0 |
Quality of life score
| ||||
3 months | 350,53,56 (277) | -4.47 (54%) | -3.65 (47%) | -0.40 (-1.25, 0.45), .35 |
1 year | 352–54 (332) | -4.05 (49%) | -4.34 (56%) | 0.63 (0.12, 1.15), .01 |
2 years | 252,54 (273) | -3.90 (47%) | -5.67 (74%) | 1.69 (-1.05, 4.44), .22 |
3 years | 252,54 (273) | -4.17 (50%) | -5.18 (67%) | 1.02 (0.14, 1.90), .02 |
4 years | 154 (121) | -6.6 (80%) | -8.90 (116%) | 2.3 (1.84, 2.76), .00 |
5 years | 154 (121) | -8.0 (96%) | -8.60 (112%) | 0.6 (0.21, 0.99), .00 |
Qmax (mL/s)
| ||||
3 months | 350,53,56 (277) | 4.85 (57%) | 11.37 (148%) | -6.48 (-7.29, -5.68), .00 |
1 year | 452–54,57 (375) | 6.49 (76%) | 12.23 (160%) | -5.9 (-7.73, -4.08), 00 |
2 years | 450,54,57,58 (430) | 4.55 (53%) | 12.17 (159%) | -7.93 (-11.1, -4.77), .00 |
3 years | 252,54 (273) | 5.6 (66%) | 10.80 (141%) | -5.32 (-6.78, -3.85), .00 |
4 years | 154 (121) | 2.9 (34%) | 10.10 (132%) | -7.2 (-7.99, -6.4), .00 |
5 years | 154 (121) | 2.6 (30%) | 9.8 (127%) | -7.2 (-7.93, -6.47), .00 |
PVR (ml)
| ||||
3 months | 350,53,56 (277) | -27.76 (31%) | -44.66 (44%) | 23.82 (-19.35, 66.97), .28 |
1 year | 353,54,57 (223) | -21.92 (24%) | -52.42 (51%) | 24.97 (20.90, 29.05), .00 |
2 years | 354,57,58 (278) | -27.58 (31%) | -69.24 (68%) | 35.8 (25.00, 46.61), .00 |
5 years | 154 (121) | -31.40 (35%) | -54.50 (53%) | 23.1 (12.16, 43.04), .00 |
PdetQmax (cm of water)
| ||||
6 months | 251,58 (235) | -20.52 (27%) | -32.4 (45%) | 13.12 (0.6, 25.65), .04 |
2 years | 158 (114) | -28.56 (38%) | -42 (58%) | 13.44 (11.6,15.27), .00 |
No. Abrams-Griffiths
| ||||
6 months | 151 (121) | -24 (39%) | -47.40 (81%) | 23.4 (20.7, 26.2), .00 |
Prostatic size
| ||||
3 months | 250,58 (235) | -2.66 (7%) | -12.98 (34%) | 10.13 (-7.02,27.3), .02 |
1 year | 150 (121) | -0.9 (2.4%) | -5.5 (17%) | 6.4 (4.8,7.96), .00 |
2 years | 253,58 (173) | -6.46 (15%) | -12.78 (34%) | 5.52 (-2.7,13.75), .19 |
Safety
Use of healthcare resources
2. TUNA vs. other minimally invasive therapies
Variable | No. studies (patients) | TUNA Difference in means (% improvement) | TUMT Difference in means(% improvement) | TUNA vs. TUMT WMD (95% CI), P value |
---|---|---|---|---|
Symptom score
| ||||
Pre-3 months | 156 (76) | -9.3 (48%) | -5.2 (28%) | -4.1 (-5.02, -3.18), .00 |
Quality-of-life score
| ||||
Pre-3 months | 156 (76) | -2.3 (49%) | -1.7 (39%) | -0.6 (-0.75, -0.44), .00 |
Qmax (mL/s)
| ||||
Pre- 3 months | 156 (76) | 1 (11%) | 0.9 (12%) | 0.1 (-0.47, 0.67), .73 |
Variable | No. studies (patients) |
TUNA
Difference in means (% improvement) |
WIT
Difference in means (% improvement) |
TUNA vs. WIT
WMD (95% CI), P value |
Qmax (ml/sec
| ||||
Pre- 6 months | 158 (37) | 3.2 (41%) | 1.8 (14%) | 1.4 (-0.13, 2.93), .07 |
Pre- 2 years | 158 (37) | 4.9 (44%) | 2.2 (18%) | 2.7 (1.14, 4.26), .00 |
PVR (mL)
| ||||
Pre- 6 months | 158 (37) | -58.3 (62%) | -18.5 (25%) | -39.8 (-46.4, -33.2), .00 |
Pre- 2 years | 158 (37) | -40.9 (54%) | -23.3 (49%) | -17.6 (-24, -11.2), .00 |
P
det
at Qmax (cm H
2
O)
| ||||
Pre- 6 months | 158 (37) | -22.52 (35%) | -17.5 (27%) | -5.02 (-9.36, -0.65), .02 |
Pre- 2 years | 158 (37) | -28.56 (44%) | -15.7 (25%) | -12.9 (-17.4, -8.34), .00 |
Variable | No. studies (patients) |
TUNA
Difference in means (% improvement) |
ILC
Difference in means (% improvement) |
TUNA vs. ILC
WMD (95% CI), P value |
Symptom score
| ||||
Pre- 3 months | 156 (84) | -9.3 (48%) | -12.4 (64%) | 3.1 (2.36, 3.84), .00 |
Quality-of-life score
| ||||
Pre- 3 months | 156 (84) | -2.3 (49%) | -2.5 (58%) | 0.2 (0.06, 0.34), .00 |
Qmax (mL/s)
| ||||
Pre- 3 months | 156 (84) | 1 (11%) | 5 (53%) | -4 (-4.64, -3.36), .00 |
Pre- 6 months | 158 (95) | 3.2 (41%) | 2.8 (30%) | 0.4 (-0.15, 0.95), .15 |
Pre- 2 years | 158 (95) | 4.9 (44%) | 3 (32%) | 1.9 (1.27,2.52), .00 |
PVR (mL)
| ||||
Pre- 3 months | 156 (84) | -22.1 (26%) | -71.9 (72%) | 49.8 (41.99, 57.60), .00 |
Pre- 6 months | 158 (95) | -58 (62%) | -45 (45%) | -13 (-16.41, -10.2), .00 |
Pre- 2 years | 158 (95) | -41 (54%) | -42 (42%) | 1.3 (-2.07, 4.67), .45 |
P
det
at Qmax (cm H
2
O)
| ||||
Pre- 6 months | 158 (95) | -22.5 (35%) | -25.8 (38%) | 3.28 (1.4, 5.16), .00 |
Pre- 2 years | 158 (95) | -28.6 (44%) | -23 (34%) | -5.56 (-7.76, -3.36), .00 |
Variable | No. studies (patients) |
TUNA
Difference in means (% improvement) |
TUVP
Difference in means (% improvement) |
TUNA vs. TUVP
WMD (95% CI), P value |
Symptom score
| ||||
Pre- 6 months | 157 (32) | -9 (47%) | -13.1 (69%) | 4.1 (2.38, 5.82), .00 |
Pre-1 year | 157 (32) | -11.2 (58%) | -13.3 (70%) | 2.1 (0.72, 3.48), .00 |
Pre- 2 years | 157 (32) | -10 (52%) | -12.7 (66%) | 2.7 (1.13, 4.27), .00 |
Qmax (mL/s)
| ||||
Pre- 6 months | 257,58 (69)a
| 3.42 (41%) | 10.25 (108%) | -6.08 (-8.6, -3.5), .00 |
Pre- 1 year | 157 (32) | 2.6 (30%) | 12.4 (132%) | -9.8 (-10.97, -8.63), .00 |
Pre- 2 years | 257,58(69)b
| 2.76 (44%) | 8.93 (97%) | -6.1 (-11.45, -0.67), .00 |
PVR (mL)
| ||||
Pre- 6 months | 257,58 (69)c
| -57.26 (62%) | -61.84 (76%) | 10.96 (0.26, 21.65), .04 |
Pre- 1 year | 157 (32) | -53 (62%) | -51 (67%) | -2 (-16.15, 12.15), .78 |
Pre- 2 years | 257,58 (69)b
| -42.06 (54%) | -61.20 (74%) | 10.87 (-20.54, 42.3), .49 |
P
det
at Qmax (cm H
2
O)
| ||||
Pre- 6 months | 158 (37) | -22.52 (35%) | -40 (53%) | 17.48 (13.8, 21.2), .00 |
Pre- 2 years | 158(37) | -28.56 (44%) | -35 (47%) | 6.44 (2.32, 10.56), .00 |
Variable | No. studies (patients) |
TUNA
Difference in means (% improvement) |
VLAP
Difference in means (% improvement) |
TUNA vs. VLAP
WMD (95% CI), P value |
Symptom score | ||||
Pre- 6 months | 157 (30) | -9 (47%) | -7.3 (37%) | -1.7 (-4.0,0.62), .15 |
Pre-1 year | 157 (30) | -11.2 (58%) | -10.8 (55%) | -0.4 (-2.48, 1.68), .70 |
Pre- 2 years | 157 (30) | -10 (52%) | -12.9 (65%) | 2.9 (1.3, 4.5), .00 |
Qmax (mL/s)
| ||||
Pre- 6 months | 157 (30) | 4.3 (41%) | 8.6 (141%) | -4.3 (-6.17, -2.43),.00 |
Pre- 1 year | 157 (30) | 2.6 (30%) | 7.8 (128%) | -5.2 (-6.3, -3.57), .00 |
Pre- 2 years | 157 (30) | 2.3 (44%) | 5.6 (92%) | -3.3 (-4.7, -1.8), .00 |
PVR (mL)
| ||||
Pre- 6 months | 157 (30) | -44 (62%) | -63 (67%) | 19 (1.90, 36.1), .02 |
Pre- 1 year | 157 (30) | -53 (62%) | -64 (68%) | 11 (-6.44, 28.44), .2 |
Pre- 2 years | 157 (30) | -55 (54%) | -68 (72%) | 13 (-5.6, 31.6), .17 |
Variable | No. studies (patients) |
TUNA
Difference in means (% improvement) |
HIFU
Difference in means (% improvement) |
TUNA vs. HIFU
WMD (95% CI), P value |
Symptom score | ||||
Pre- 6 months | 157 (35) | -9 (47%) | -8.3 (56%) | -0.7 (-2.35, 0.95), .40 |
Pre- 1 year | 157 (35) | -11.2 (58%) | -10.4 (71%) | -0.8 (-2.11, 0.51), .23 |
Pre- 2 years | 157 (35) | -10 (52%) | -7 (48%) | -3.0 (-4.71, -1.29), .00 |
Qmax (mL/s)
| ||||
Pre- 6 months | 157 (35) | 4.3 (41%) | 3.9 (42%) | 0.40 (-9.4, 1.74), .55 |
Pre- 1 year | 157 (35) | 2.6 (30%) | 3.9 (42%) | -1.30 (-2.16, -0.44), .00 |
Pre- 2 years | 157 (35) | 2.3 (44%) | 2 (22%) | 0.30 (-0.52, 1.12), .47 |
PVR (mL) | ||||
Pre- 6 months | 157 (35) | -44 (62%) | -48 (51%) | 4.00(-10.44, 18.44), .58 |
Pre- 1 years | 157 (35) | -53 (62%) | -45 (48%) | -8.00 (-22.44, 6.44), .27 |
Pre- 2 years | 157 (35) | -55 (54%) | -36 (38%) | -19 (33.69, -4.31), .01 |
TUNA | TUMT | ILC | TUVP | VLAP | HIFU | WIT | |
---|---|---|---|---|---|---|---|
Erectile dysfunction | 7 (20%) | 6 (26%) | 7 (18%) | -- | -- | -- | -- |
Epidydimitis | 0 (0%) | -- | -- | 0 (0%) | -- | -- | -- |
Urethral stenosis | -- | -- | -- | 2 (15%) | -- | -- | -- |
Retrograde ejaculation | 9 (14%) | -- | 16(15%) | 12 (92%) | -- | -- | -- |
Fever | -- | -- | 1(1.4%) | 1 (7.7%) | -- | -- | -- |
Transitory incontinence | -- | -- | -- | 2 (15%) | -- | -- | -- |
Urinary infection | -- | -- | -- | 2 (15%) | -- | -- | -- |
Urinary retention | -- | -- | -- | 1 (5.9%) | -- | -- | 3 (24%) |
Rehospitalization | 1 (6.7%) | -- | -- | 1 (5.9%) | 1 (7%) | 1 (5%) | 4 (30.7%) |
Irritative symptoms | -- | -- | 30 (42%) | -- | -- | -- | -- |
Reduction in seminal volume | -- | -- | 15 (21%) | -- | -- | -- | -- |
Hematuria | 1 (6.8%) | -- | 25 (35.2%) | 2 (11.8%) | 0 (0%) | 1 (5%) | -- |
Dysuria | 2 (8.3%) | -- | -- | -- | -- | -- | -- |
Change in sexual activity | 0 (0%) | -- | -- | -- | -- | -- | -- |