Evidence Table 35Transurethral microwave thermotherapy (TUMT) vs. transurethral resection of the prostate (TURP)

Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Ahmed et al., 19979

Reported in systematic review HTA 2008

Study design:
RCT

Setting: Single centre, UK

Evidence level: 1+

Duration of follow-up:
6 months
Patient group: Patients presenting with symptomatic, uncomplicated BPH.

Inclusion criteria: residual urine volume ≤300 ml; AUA score ≥ 12; urine flow rate< 15ml/s, prostate volume 25-100ml by TRUS; symptomatic uncomplicated BPH > 1 year; pdet max>70cm H2O; informed consent; obstructed on Abrams-Griffith nomogram; suitable for either treatment.

Exclusion criteria: <55years; prostate cancer; previous prostatic surgery; acute or chronic retention; mental incapacity; severe cardiovascular disease; rectal surgery or disease; pelvic mass surgery; cardiac pace marker; metallic implants; uncontrolled coagulation disorder; meatal stricture; upper tract dilation; obstructive uropathy; bladder calculi; bladder diverticuli; recurrent prostatic haematuria; active drugs; previous medication for BPH; prostatic abscess; active UTI; recurrent UTI; prominent middle lobe.

Group 1
N: 30
Mean (range) age: 69.36 (56-88)
Mean AUA score (95% CI): 18.5 (17.1-20.1)
Dropouts: 0

Group 2
N: 30
Mean (range) age: 69.45 (58-82)
Mean AUA score (95% CI): 18.4 (16.7-20.1)
Dropouts: 0
Group 1: TUMT
With urethral cooling in a high energy protocol (Prostratron version 2.5). Temperature 43.5 degrees, power at 70W.

60 minute session under topical anaesthesia with instillagel.
3 required parenteral pethidine.
Antibiotics: gentamycin (80mg) before treatment and oral trimethoprim, 200mg, 2 times day for 5 days.

Group 2: TURP
No post operative irrigation was used. Urethral catheter was removed 3 or 4 days after surgery.
Mean (range) [SD] AUA symptom scores:Baseline:
Group1: 18.5 (17.1-20.1)
Group 2: 18.4 (16.7-20.1)
6 months:
Group1: 5.3 (3.9-6.4) [3.5]
Group 2: 5.2 (3.9-6.5) [3.6]
Funding: NR

Limitations:
3 drop outs after randomisation were substituted. One emigrated to Australia; one developed severe UTI requiring hospital admission and one patient could not be catheterised with the treatment catheter.

Method of randomisation and use of blinding unclear.

Additional outcomes:
None

Notes:
Urodynamic outcomes improved in TURP group but not after TUMT.
AUA symptom score decreased > 50%Group 1: 18/30 (60%)
Group 2: 30/30 (100%)
Qmax (mL/s):Baseline:
Group1: 10.1 (9.2-10.9)
Group 2: 9.5 (8.9-10.1)
6 months:
Group1: 9.1 (8.0-10.2)
Group 2: 14.6 (13.4-15.8)
Pdet max (cmH20):Baseline:
Group1: 98.5 (70.1-116.9)
Group 2: 96.7 (85.5-103.9)
6 months:
Group1: 105.6 (73.7-117.5)
Group 2: 48.8 (44.3-52.7)
PVR (mL):Baseline:
Group1: 94.4 (70.0-112.8)
Group 2: 109.1 (88.2-130.0)
6 months:
Group1: 104.9 (78.9-130.9)
Group 2: 32.5 (22.5-40.5)
Prostate volume (mL):Baseline:
Group1: 36.6 (31.8-41.4)
Group 2: 46.1 (38.1-54.1)
6 months:
Group1: 34.5 (29.7-39.3)
Group 2: 25.4 (19.4-31.4)
Blood transfusion:Group 1: 0/30
Group 2: 4/30
Urinary tract infection:Group 1: 1/30
Group 2: 3/30
Strictures:Group 1: 0/30
Group 2: 1/30
Retrograde ejaculation
(sexually active men only):
Group 1: 4/18
Group 2: 12/19
Hematuria:Group 1: 1/30
Group 2: 0/30
Erectile dysfunction:Group 1: 0/18
Group 2: 4/19
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Delarosette et al., 200365
Reported in systematic review HTA 2008

Study design:
RCT
Setting:
Netherlands
Evidence level: 1+
Duration of follow-up:
Median 33 months.
Patient group: From January 1996 to March 1997 patients with LUTS suggestive of BPH were recruited.

Inclusion criteria: age ≥ 45 years; duration of LUTS ≥ 3 months, prostate volume ≥ 30 mL; urethral length ≥ 25mm; peak urine flow rate ≤ 15ml/s; Residual urine volume ≤ 350 ml; and severe co morbidity.

Exclusion criteria: acute prostatitis or urinary tract infection; prostate carcinoma; previous prostatic surgery; heart pacemaker; neurological disorders affecting lower urinary tract function; isolate prostate middle lobe protruding in bladder; urethral stricture.

All patients
N: 155
Group 1: 82
Group 2: 73
Drop outs: 11 (10 refused and 1 died) - 4 from Group 1 and 7 in Group 2. Not included in the ITT analysis as no follow-up data.

Group 1
N: 78
Mean (±SD) Age: 67(±8.3)
Mean (±SD) IPSS: 20 (±6.7)
Dropouts: 23 (5 lost to follow up and 2 died unrelated causes, 16 re-treated by TURP=8, laser prostatectomy=1, cystolithotripsy=2, internal optical urethrotomy=1, TUMT=1, alpha blockers=3).

Group 2
N: 66
Mean (±SD) Age: 66 (±8.2)
Mean (±SD) IPSS: 20 (±6.3)
Dropouts: 21 (11 lost to follow up and 2 died of unrelated causes, 8 retreated by bladder neck incisions=3, internal optical urethrotomy=2, physiotherapy=1, medication=2).
Group 1: TUMT
Prostatron device and Prostasoft 2.5 software. Administered under local anaesthesia. Outpatient procedure.

Group 2: TURP
Under spinal anaesthesia.
Mean in-hospital stay of 5.3 days.
Mean (SD) symptom score IPSSBaseline:
Group1 (n=78): 20 (6.7)
Group 2 (n=66): 20 (6.2)
3months:
Group 1: (n=57): 10.5 (7.9)
Group 2 (n=55): 5.3 (5.2)
1 year:
Group1 (n=58): 8.1 (6.0)
Group 2 (n=48): 3.2 (3.0)
2 years:
Group1 (n=46): 9.3 (7.3)
Group 2 (n=38): 3.7 (4.9)
3 years:
Group1 (n=35): 11.5 (6.4)
Group 2 (n=33): 2.6 (2.2)
Funding: NR

Limitations:
Method of randomisation, allocation concealment and blinding unclear.

Additional outcomes:
Cost analysis was performed.

Notes:
Links with Francisca 1999, Francisca 2000, Floratos 2001.
Mean (SD) IPSS Quality of life questionBaseline:
Group1 (n=78): 4 (0.9)
Group 2 (n=66): 4(1.1)
1 year:
Group1 (n=58): 1.9 (1.3)
Group 2 (n=48): 0.6 (0.7)
2 years:
Group1 (n=46): 1.9 (1.0)
Group 2 (n=38): 0.9 (1.1)
3 years:
Group1 (n=35): 2.3 (1.2)
Group 2 (n=33): 0.6 (0.8)
Mean (SD) Maximum urinary flow (Qmax, mL/s)Baseline:
Group1: 9.2 (3.1)
Group 2: 7.8 (2.8)
3 months:
Group1 (n=54): 15.5 (12.1)
Group 2 (n=47): 25.0 (7.5)
1 year:
Group1: 14.9 (7.2)
Group 2: 23.8 (10.4)
2 years:
Group1: 13.7 (6.4)
Group 2: 22.5 (11.4)
3 years:
Group1: 11.7 (5.8)
Group 2: 22.8 (11.6)
Mean (SD) post void residual (PVR, mL)Baseline:
Group1: 68 (85)
Group 2: 97 (99)
1 year:
Group1: 55 (69)
Group 2: 20 (49)
2 years:
Group1: 91 (116)
Group 2: 29 (39)
3 years:
Group1: 94 (114)
Group 2: 35 (56)
Patients with re-treatment:Group1: 16/78 22.9% (12.5-33.2)
Group 2: 8/66 13.2 (4.5-21.9), P=0.215
Kaplan-Meier risk of retreatment (36 months)Group 1: 22.9 (12.5-33.2)%
Group 2: 13.2 (4.5-21.9)%, P=0.215
Urinary retention:Group 1: 2/78 (3%)
Group 2: 0/66 (0%)
Urinary incontinence:Group 1: 0/78 (0%)
Group 2: 1/66 (2%)
Stricture:Group 1: 1/78 (1%)
Group 2: 2/66 (3%)
Mortality (unrelated causes)Group 1: 2/78 (3%)
Group 2: 2/66 (3%)
Retrograde ejaculation
(reported in HTA 2008)
Group 1: 24/36 (67%)
Group 2: 5/42 (12%)
Erectile dysfunctionGroup 1: 7/35 (20%)
Group 2: 9/53 (17%)
ReoperationGroup 1: 13/78 (17%)
Group 2: 5/66 (8%)
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Mattiasson et al., 2007186 and Wagrell et al., 2002312

Reported in systematic review HTA 2008

Study design:
RCT

Setting:
Sweden, Denmark and USA

Evidence level:
1+

Duration of follow-up:
60 months
Patient group: Patients from ten centres in Scandinavia and the United States recruited between October 1998 and November 1999.

Inclusion criteria: symptomatic BPH, peak urine flow rate ≤ 13ml/s; ml; IPSS score ≥ 13; prostate volume 30-100ml.

All patients
N: 154 eligible
Drop outs: 8 withdrawn before treatment

Group 1
N: 100
MeanSD) Age: 67 (8)
MeanSD) IPSS: 21 (5.4
Dropouts before intervention: 3
(screening failures and not treated)
Withdrawn at 12m: 9
Withdrawn at 60m: 38 (adverse events=5, treatment failure= 10, patient request=22, other =1)

Group 2
N: 46
MeanSD) Age: 69 (8)
MeanSD) IPSS: 20.4 (5.9)
Dropouts before intervention: 5
(screening failures and not treated)
Withdrawn: 4
Withdrawn at 60m: 12 (reasons: adverse events=4, treatment failure=2, patient request=5 and other=1)
Group 1: TUMT
PLFT technique. Given as outpatient procedure requiring sedo-analgesic with or without local anaesthetic. Diazepam, ketorolac, or ketobemidone or combinations of these. Mean duration of treatment 57 (27-80) minutes.
Catheter after treatment: 14±8 days before removal.

Group 2: TURP
Urethral catheter usually removed after 3±4 days.
Mean (SD) IPSSBaseline:
Group1 (n=99): 21.0 (5.4)
Group 2 (=46): 20.4 (5.9)
3 months:
Group1 (n=85): 8.4 (5.5)
Group 2 (n=41): 6.7 (4.3)
6 months:
Group1 (n=95): 7.4 (6.2)
Group 2 (n=43): 5.9 (5.0)
12 months:
Group1 (n=93): 7.2 (6.2)
Group 2 (n=43): 7.1 (6.6)
P=0.603
24 months:
Group1 (n=77): 7.2 (5.9)
Group 2 (n=38): 4.6 (4.4)
36 months:
Group 1 (n=68): 8.2 (6.9)
Group 2 (n=35): 5.0 (3.9)
48 months:
Group 1: (n=56): 7.1 (5.4)
Group 2: (n=30):6.4 (6.6)
60 months:
Group 1 (n=63): 7.4 (4.8)
Group 2 (n=34): 6.0 (5.8)
Funding: ProstaLund. Authors (Wagrell, Schelin, Larson, Mattiasson) are paid consultants to the sponsor of this study.

Limitations:
Method of randomisation, allocation concealment and blinding not reported.

Additional outcomes:
Detrusor pressure Qmax at 3 and 6 months.

Notes:
% of responders at 12 months defined as those with an IPSS of 7 or less or > 50% gain compared with baseline and/or a Qmax of 15mL/s or greater and/or > 50% gain.

Links with Wagrell 2004313
Mean (SD) IPSS Quality of life:Baseline:
Group1 (n=99): 4.3 (1.0)
Group 2 (n=46): 4.2 (1.1)
3 months:
Group1 (n=84): 1.5 (1.4)
Group 2 (n=41): 1.1 (1.6)
6 months:
Group1 (n=93): 1.3 (1.4)
Group 2 (n=42): 1.0 (1.5)
12 months:
Group1 (n=93): 1.4 (1.3)
Group 2 (n=43): 1.5 (1.7)
24 months:
Group 1 (n=77): 1.3 (1.2)
Group 2 (n=38): 0.9 (1.3)
36 months:
Group 1 (n=68): 1.3 (1.2)
Group 2 (n=35): 1.0 (1.4)
48 months:
Group 1: (n=56): 1.2 (1.0)
Group 2: (n=30): 1.0 (1.3)
60 months:
Group 1 (n=63): 1.1 (0.9)
Group 2 (n=34): 1.1 (1.2)
Urinary flow rate (Qmax mL/s):Baseline:
Group1 (n=79): 7.6 ± 2.7
Group 2 (n=35): 7.9 ± 2.7
3 months:
Group1 (n=81): 12.8 ± 6.1
Group 2 (n=41): 14.6 ± 9.0
6 months:
Group1 (n=91): 13.5 ± 6.1
Group 2 (n=43): 13.8 ± 6.8
12 months:
Group1 (n=73): 13.3 ± 6.0
Group 2 n=31): 15.2 ± 7.8
24 months:
Group 1 (n=77): 12.4 ±5.3
Group 2 (n=37): 15.6 ±9.6
36 months:
Group 1 (n=66): 11.9± 4.9
Group 2 (n=34): 13.5± 7.4
48 months:
Group1 (n=49): 12.3 ± 5.7
Group 2 (n=30: 14.7 ± 7.57
60 months:
Group 1 (n=61): 11.4 (4.9)
Group 2 (n=32): 13.6 (7.8)
Mean (SD) residual urine in mLBaseline:
Group1 (n=99): 106 ± 77
Group 2 (n=45): 94 ± 82
12 months:
Group1 (n=86): 49 ± 70
Group 2 (n=38): 54 ± 77
24 months:
Group1 (n=75): 56 (63)
Group 2 (n=38): 40 (48)
36 months:
Group1 (n=68): 47 (62)
Group 2 (n=34): 54 (118)
48 months:
Group1 (n=55): 60 (59)
Group 2 (n=29): 55 (53)
60 months:
Group 1 (n=63): 70 (90)
Group 2 (n=32): 51 (45)
Reduction in prostate volume (after 12 months):Group1 (n=16): 30%
Group 2 (n=13): 51%
Additional BPH treatment (5 year follow-up)Group 1: 10/100 (10%)
Group 2: 2/46 (4.3%)
Mortality (27 days after treatment)Group 1: 0/100
Group 2: 1/46
ComplicationsMicturition urgency at 12months:
Group 1: 37/100 (37%)
Group 2: 6/46 (13%)

Urinary retention:
0-12 months:
Group 1: 19/100 (19%)
Group 2: 6/46 (13%)
12-60 months
Group 1: 2/80 (2.5%)
Group 2: 0/39

Urinary tract infection:
12 months:
Group 1: 18/100 (18%)
Group 2: 9/46 (20%)
12-60 months:
Group 1: 0/80
Group 2: 1/39 (2.6%)

Haematuria: 12 months
Group 1: 13/100 (13%)
Group 2: 18/46 (39%)
12-60 months:
Group 1: 5/80 (6.3%)
Group 2:0

Erectile dysfunction:
12 months:
Group 1: 6/100 (6%)
Group 2: 5/46 (11%)

12-60 months:
Group 1: 6/80 (7.5%)
Group 2: 6/39 (15.4%)

Transient incontinence 12 months:
Group 1: 3/100 (3%)
Group 2: 6/46 (13%)
12-60 months:
Group 1: 1/80 (1.3%)
Group 2: 2/39 (5.1%)

TUR syndrome:
Group 1: 0/100
Group 2: 1/46

Reoperation (up to 60 months):
Group 1: 8/100
Group 2: 1/46
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Dahlstrand et al., 199362 Reported in systematic review HTA 2008

Study design:
RCT

Setting:
Sweden

Evidence level:
1+

Duration of follow-up:
12 months
Inclusion criteria: residual urine volume ≤ 350ml; Madsen score ≥ 8; prostate length 35-50mm from TRUS. Qmax <15m/s (twice); BPH; anaesthetic risk group 1-3; obstructive symptoms > 3 months.

Exclusion criteria: <45 years; suspicion or known prostate cancer or bladder cancer; previous surgery for cancer of prostate or radiotherapy; rectal surgery; prior surgery or heat treatment of BPH; large median lobe; neurogenic bladder disorder; mental incapacity, dementia or inability to give informed consent; neurological disorders that may affect bladder function; peripheral arterial disease; disorder of haemostasis or serum creatinine >2mg/dl; uncontrolled cardiac dysrhythmias, or cardiac pacemaker; total hip replacement or other metallic implants; indwelling or condom catheter; post void residual urine >350ml; urethral stricture; bladder stones; adrenergic blockers antiandrogen medication or other medication that might affect prostate or bladder; bacterial prostatitis or UTI at time of treatment ; prostatic urethral length of >50mm or <35mm by transrectal US; anaesthesia risk category 4 or 5.

All patients
N: 79
Drop outs: 4

Group 1
N: 39
Mean Age: 68
Prostate volume: 33ml
Mean Madsen ±SD: 11.2± 3.1
Dropouts: 0

Group 2
N: 40
Mean Age:70
Prostate volume: 37ml
Mean Madsen ± SD: 13.3± 4.2
Dropouts: 4 (sever hepatitis=1, cancer discovered=2, refusal for TURP=1).
Group 1: TUMT
Prostatron, Power: 60W; Temperature: urethral: 44.5 degrees and rectal 42.5 degrees.

If no voiding use indwelling catheter for 3-5 days.
No general anaesthesia but intraurethral topical lidocaine HCI jelly 2% and NSAID. Postoperative oral norfloxacin 400mg twice per day for 5 days. Treatment time 60 minutes.

Group 2: TURP
performed by urologists were senior registrar or above.
Mean operative time:
60.9 minutes.
Hospital stay: 5 ±1.9 days
Mean (SD) Madsen symptom scoreBaseline:
Group1 (n=39): 11.2±3.1
Group 2(n=39): 13.3±4.2
3 months:
Group1(n=37): 2.3±2.7
Group 2(n=39): 1.6±2.5
6 months:
Group1(n=28): 3.1±3.0
Group 2(n=23): 0.9±1.6
12 months:
Group1(n=25): 2.7±2.9
Group 2(n=22): 0.9±2.2
Funding: NR

Limitations:
Method of randomisation, allocation concealment and blinding not reported.

Additional outcomes:
Maximum capacity change.
Additional follow-up 6-8 weeks after surgery.

Notes:
* Catheterisation required but removed within 3-5 days.
Mean (SD) residual urine volume (ml)Baseline:
Group1 (n=39): 105±88
Group 2 (n=40): 116±97
3 months:
Group1(n=37): 55±51
Group 2(n=39): 31±25
6 months:
Group1(n=28): 68±69
Group 2(n=24): 17±10
12 months:
Group1 (n=24): 47±51
Group 2 (n=22): 22±16
Mean (SD) maximum flow rate (ml/s)Baseline:
Group1 (n=39): 8.0±2.8
Group 2 (n=40): 7.9±3.2
3 months:
Group1 (n=35): 12.2±4.9
Group 2 (n=37): 18.7±6.0
6 months:
Group1 (n=32):12.0±4.5
Group 2 (n=24): 18.8±5.9
12 months:
Group1 (n=24): 12.3±4.7
Group 2 (n=22): 17.7±6.5
Reoperation:Group1: 4/39 (10.2%)
Group 2: 0/40
Re-catheterisation due to unable to void:Group1: 8/39*
Group 2: 2/40
Transient urgency after surgeryGroup 1: 7/39
Group 2: 4/40
Transient urinary leakageGroup 1: 0/39
Group 2: 1/40 (2.5%)
Bleeding and rehospitalisationGroup 1 0/39
Group 2: 3/40
Internal urethrotomy due to strictureGroup 1: 0/39
Group 2: 3/40
Urinary tract infectionsGroup 1: 3/39
Group 2: 0/40
Men with retrograde ejaculation following surgery (previously with antegrade ejaculations)Group 1: 0
Group 2: 4/16
% Reduction in prostate size (6m)Group 1: 0
Group 2: 47
Unstable detrusor contractionsBaseline
Group 1: 6/21
Group 2: 5/13
After surgery:
Group 1: 8/21
Group 2: 2/13
Sexually active menAll men who were sexually active before treatment remained so after.
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Dahlstrand et al., 199563 Reported in systematic review HTA 2008

Study design:
RCT

Setting:
Sweden

Evidence level:
1+

Duration of follow-up:
2 years
Inclusion criteria: residual urine volume ≤ 350ml; Madsen score ≥ 8; prostate length 35-50mm from TRUS.

Exclusion criteria: prostate cancer or bladder cancer; previous surgery for cancer of prostate; prior treatment for BPH; indwelling catheter, urethral stricture; large median lobe; neurogenic bladder disorder, metallic hip implant.

All patients
N: 72 eligible – 69 randomised
Drop outs: 10

Group 1
N: 37
Mean Age: 67.9±9
Mean Madsen ± SD: 12.1± 3
Dropouts: 2 (died=1, hernia operation=1)

Group 2
N: 32
Mean Age:70±6
Mean Madsen ± SD: 13.6± 3.9
Dropouts: 8 (TURP=2, abroad=1, refused=1, severe pancreatitis= 1, neurological disease=1, reoperation with TUMT and then TURP=2)
Group 1:
TUMT
Prostatron (Prostasoft 2.0 software) – 60W. Treatment in single session as outpatient. Intra-urethrally applied lidocaine hydrochloride jelly used. Before treatment patients given indomethacin 50mg and norfloxacin 400mg was given; after treatment indomethacin given twice for one day and norfloxacin 400mg twice daily for 5 days.

Group 2:
TURP by senior registrar grade or above. Mean operation time=48±17 minutes. Mean hospital stay=3.9±1.3 days.
Madsen symptom scoreBaseline:
Group1 (n=37): 12.1±3.0
Group 2 (n=32): 13.6±3.9
3 months:
Group1 (n=36): 2.9±3.0
Group 2 (n=32): 1.7±2.6
6 months:
Group1 (n=37): 2.6±2.6
Group 2 (n=32): 1.1±1.8
12 months:
Group1 (n=33): 2.2±2.4
Group 2 (n=31): 0.6±1.4
24 months:
Group1 (n=31): 2.3±3.0
Group 2 (n=30): 1.2±1.9
Funding: NR

Limitations:
Method of randomisation, use of allocation concealment and blinding were not reported.

Unsure if same study as Dahlstrand 1993 – HTA attempted to contact authors.

Additional outcomes:
Volume at first sensation to void after 6 months. Detrusor contractions and urethral resistance factor.

Notes:
Reoperation: TUMT group=4: 2 retreated by TURP, 2 by TUMT; the TUMT reoperations had TURP at 1 year due to unsatisfactory improvement. TURP group: reoperation from early complication=3 due to bleeding or to remove clots; 1 retreatment after 1 year due to bladder neck sclerosis.
Reduction in symptom score > 50%Group1: 26/31
Group 2: 29/30
Maximum flow rate (mL/s)Baseline:
Group1 (n=37): 8.6±2.5
Group 2 (n=32): 8.6±3.0
3 months:
Group1 (n=36): 11.6±4.2
Group 2 (n=32): 18.1±7.1
6 months:
Group1 (n=37): 11.8±3.9
Group 2 (n=31): 18.6±5.2
12 months:
Group1 (n=33): 12.6±3.9
Group 2 (n=31): 18.9±6.0
24 months:
Group1 (n=30): 12.3±4.4
Group 2 (n=29): 17.6±5.9
Residual urine volume (mL)Baseline:
Group1 (n=37): 194±78
Group 2 (n=32): 1104±95
3 months:
Group1 (n=36): 147±45
Group 2 (n=32): 134±32
6 months:
Group1 (n=37): 166±64
Group 2 (n=32): 134±30
12 months:
Group1 (n=33):152±64
Group 2 (n=31): 123±18
24 months:
Group1 (n=31):148±44
Group 2 (n=30):127±2
Prostate volumeBaseline:
Group1: 33.9±11.9
Group 2: 36.8 ±16
2 years:
Group1: 30.3 ±9.6
Group 2: 22.5±10.9
Reoperation:Group1: 4/37
Group 2: 1/32
Catheterisation due to failure to voidGroup1: 5/37
Group 2: 0/32
Transient rectal pain in perineumGroup1: 1/37
Group 2: 0/32
Urethral strictureGroup1: 0/37
Group 2: 2/32
Meatal stenosisGroup1: 0/37
Group 2: 2/32
Urinary tract infectionGroup1: 5/37
Group 2: 4/32
Mortality (brain tumour)Group 1: 0/37
Group 2: 1/32
Erectile dysfunctionGroup 1: 0/37
Group 2: 0/32
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
D'Ancona et al., 199861 Reported in systematic review HTA 2008

Study design:
RCT

Setting:
Netherlands

Evidence level:
1+

Duration of follow-up:
2.5 years
Patient group: Between January 1994 and August 1995 patients recruited.

Inclusion criteria: unequivocal BPH candidates for TURP. Qmax 15ml/s; residual volume <350ml; Madsen score ≥ 8; prostate length 25-50mm, Prostate Volume 30-100ml; 45 years plus.

Exclusion criteria: prostate cancer; prior prostate surgery; urinary retention requiring catheterisation; medications prescribed for prostate/bladder treatment; neurogenic disorders affecting bladder function; diabetic neuropathy; possible microwave sensitive implants (pacemaker, hip prosthesis); renal impairment or obstructed bladder neck due to enlarged median lobe of prostate

All patients
N: 52

Group 1
N: 31
Mean Age ± SD: 69.6 ± 8.5
Mean IPSS ± SD: 18.3 ± 6.3
Dropouts: 14 (6 TURP, 1 died, 5 refused or lost to follow up, 2 medication)

Group 2
N: 21
Mean Age ± SD: 69.3 ± 5.9
Mean IPSS ± SD: 16.7± 5.6
Drop outs: 9 (4 refused or lost to follow up, 1 bladder neck incision, 1 bladder carcinoma, 1 at own request, 2 dementia)
Group 1:
TUMT – Prostatron software version 2.5. Total mean energy applied 151.8kJ. 100mg suppository of diclofenac administered and 2mg of medazolam injected. No additional anaesthesia during treatment. Out patient.
Prolonged catheterisation: 12.7 days.

Group 2:
TURP by 2 urologists and resection performed under spinal anaesthesia. Mean length of hospital stay 4.1. Mean catheterisation 4.1 days.
Mean (SD) IPSS score:Baseline:
Group1 (n=31): 18.3 (6.3)
Group 2 (n=21): 16.7 (5.6)
3months:
Group1 (n=31): 15.1 (8.2)
Group 2 (n=21): 5.1 (3.1)
6 months:
Group1 (n=28): 6.7 (5.5)
Group 2 (n=20): 4.0 (2.1)
12 months:
Group1 (n=27): 5.0 (2.7)
Group 2 (n=17): 3.4 (2.2)
30 months:
Group1 (n=17): 7.9 (6.3)
Group 2 (n=12): 6.3 (4.8)
Funding: NR

Limitations:
Method of randomisation, allocation concealment and blinding unclear.

Additional outcomes:
Madsen score, voided volumes, URA and LPURR.

Notes:
Links with D'Ancona 199760
Qmax (mL/s)Baseline:
Group1 (n=31): 9.3 (3.9)
Group 2 (n=21): 9.3 (3.4)
3months:
Group1 (n=31): 15.5 (8.0)
Group 2 (n=21): 19.6 (11.2)
6 months:
Group1 (n=38): 17.0 (7.5)
Group 2 (n=20): 15.3 (5.9)
12 months:
Group1 (n=27): 17.1 (7.8)
Group 2 (n=17): 19.3 (29.8)
30 months:
Group1 (n=17): 15.1 (9.6)
Group 2 (n=12): 19.1 (8.2)
PVR (mL)Baseline:
Group1 (n=31): 49.5 (69.9)
Group 2 (n=21): 91.1 (104.7)
3months:
Group1 (n=31): 25.5 (58.1)
Group 2 (n=21): 10.5 (24.5)
6 months:
Group1 (n=28): 30.6 (41.0)
Group 2 (n=20): 52.7 (70.7)
12 months:
Group1 (n=27): 70.4 (81.3)
Group 2 (n=17): 23.6 (29.8)
30 months:
Group1 (n=17): 27.4 (49.1)
Group 2 (n=12): 9.3 (14.6)
Pdet Qmax (cmH20)Baseline
Group1: 77.7 (40.0)
Group 2: 65.4 (24.9)
6 months:
Group1: 54.0 (15.9)
Group 2: 38.5 (24.5)
Prostate volume (mL)Baseline
Group1: 43.4 (11.8)
Group 2: 44.9 (15.3)
3 months:
Group1: 36.6 (10.0)
Group 2: 23.0 (8.8)
Reoperation:Group 1: 2/31 (6.4%)
Group 2: 1/21 (4.8%)
Blood transfusionsGroup 1: 0/31
Group 2: 0/21
UTIGroup 1: 5/31 (16%)
Group 2: 1/21 (4%)
Irritative voiding symptomGroup 1: 9 (29%)
Group 2: 4 (19%)
HematuriaGroup 1: 0
Group 2: 3 (14%)
MortalityGroup 1: 1
Group 2: 0

From: Appendix D, Evidence Tables

Cover of The Management of Lower Urinary Tract Symptoms in Men
The Management of Lower Urinary Tract Symptoms in Men [Internet].
NICE Clinical Guidelines, No. 97.
National Clinical Guideline Centre (UK).
Copyright © 2010, National Clinical Guideline Centre.

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