Evidence Table 29Laser vs. transurethral microwave thermotherapy (TUMT)

Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Norby et al., 2002a223

Study design:
Randomised controlled trial (RCT)

Evidence level: 1+

Setting:
Denmark (two centres)

Duration of follow-up:
6 months
Patient group: Men ≥ 50 years between May 1996 and November 1999.

Inclusion criteria: IPSS ≥ 7, QoL. ≥ 3, obstructed according to ICS nomogram or Qmax <12mL/s; able to understand project information and have written consent.

Exclusion criteria: suspicion of prostate cancer; PVR> 350mL or urinary catheter; prostatic urethra <25 mm long, neurological disease or diabetes with abnormal cystometry; previous prostate operation; ongoing UTI; previous diagnosis of rectal cancer, intake of mediation known to influence voiding; sever peripheral arterial insufficiency; previous pelvic radiation therapy; general health condition contraindicating surgery.

All patients
N: 118
Mean age: 66
Drop outs: 8 (6.7%)

Group 1
N: 48
Mean age (SD): 65 (8)
Median catheter duration: 3 days
Median prostate volume, ml = 44
Dropouts: 4 (diagnosis changed for 3 and 2 declined surgery, of which one reported IPSS at 6m and included in results).

Group 2
N: 46
Mean age (SD): 66 (7)
Median catheter duration: 7-14 days; with longer catheterisation required after higher energy procedures.
Median prostate volume, ml = 43
Drop outs: 2 (one had TURP, other had apoplexy at 4m and only had 3m follow-up)

Group 3
N: 24
Mean age (SD): 68 (7)
Median prostate volume, ml = 44
Drop outs: 2 (prostate cancer)
Group 1: LASER
Interstitial laser coagulation. NdYag: 7-20W.
Median length of stay was 3 days.
Median catheter duration was 3 days

Group 2: TUMT
Transurethral microwave thermotherapy (TUMT). Prostatron 2.0 (n=8) or 2.5 (n=37).
Performed as an outpatient procedure (four stayed overnight and 1 patient for 2 nights). Median catheter duration was 7-14 days

Control:
TUIP (n=3) or TURP (n=18). Median catheterisation was 2 days and hospital stay 5 days.
Mean (SD) IPSS:Baseline:
Group1: 21.4 (5.8), n=44
Group 2: 20.5 (5.7), n=46
Group 3: 21.3 (6.6), n=22
6 Months:
Group1: 9.5 (6.6), n=44
Group 2: 9.5 (7.1), n=44
Mean difference: 0.00 [-2.86, 2.86]
Group 3: 6.8 (5.7), n=22
Funding: Supported by a grant from Vejle County, Denmark.

Limitations:
Had to stop early due to financial restrictions and did not reach target enrolment population.
Additional outcomes:
-

Effect on prostatic volume.

-

Results also compared to control group that had either TURP or TUIP.

-

Overall satisfaction scores reported in comparison to control group. Figures not provided.

-

Subgroup analysis comparing results from TUMT 2.0 v TUMT 2.5.

Notes: Reported in Cochrane Systematic Review by Hoffman 2000.

UTI defined as ‘symptomatic UTI requiring antibiotic treatment (infections treated both in the outpatient clinical and in primary health care were included)’.

* Erectile dysfunction and retrograde ejaculation was only estimated amongst those who had answered the relevant questions both at baseline and at the 6 month follow-up. Each question was scored from 0 to 3. For evaluation of ejaculation, patients scoring 0, 1 and 2 (i.e. normal amount, slightly reduced and greatly reduced amount of semen) were classified as having antegrade ejaculation. Patients scoring 3 (i.e. no ejaculation) were classified as having retrograde ejaculation.
Median (IQR) IPSS Quality of life:Baseline:
Group 1: 4 (4-4), n=44
Group 2: 4 (4-4), n=46
Group 3: 4 (4-5), n=22
6 Months:
Group1: 1 (1-2), n=44
Group 2: 2 (1-3), n=44
Group 3: 1 (1-2), n=22
Mean (SD) peak urinary flow
(Qmax mL/s):
Baseline:
Group1: 10.2 (4.0), n=44
Group 2: 9.1 (4.2), n=46
Group 3: 9.6 (3.2), n=22
6 Months:
Group 1: 16.2 (8.5), n=43
Group 2: 13.2 (6.9), n=44
Group 3: 20.6 (12.8), n=22
Median (IQR) post void residual, mLBaseline:
Group1: 117 (50-180), n=44
Group 2: 110 (50-210), n=46
Group 3: 75 (17-193), n=22
6 Months:
Group 1: 58 (14-118), n=43
Group 2: 48 (24-129)n=44
Group 3: 23 (3-48), n=22
Urinary retention:Group1: 4/44 (9%)
Group 2: 3/46 (7%)
Group 3: 1/22 (5%)
Urinary tract infection:Group 1: 27/44 (61%)
Group 2: 14/46 (30%)
Group 3: 3/22 (14%)
Transurethral resection syndrome (TUR)Group 1: 0/44 (0%)
Group 2: 0/46 (0%)
Group 3: 1/22 (5%)
Transfusion:Group 1: 0/44 (0%)
Group 2: 0/46 (0%)
Group 3: 2/22 (9%)
Stricture:Group 1: 1/44 (2%)
Group 2: 0/46 (0%)
Group 3: 1/22 (5%)
Urinary incontinence:Group 1: 0/44 (0%)
Group 2: 0/46 (0%)
Group 3: 1/22 (5%)
Development of erectile dysfunction:*Group 1: 4/18 (29%)
Group 2: 2/22 (9%)
Group 3: 1/7 (14%)
Development of retrograde ejaculation:Group 1: 9/26 (35%)
Group 2: 6/27 (22%)
Group 3: 7/14 (50%)
Reoperation for BPOGroup1: 0/44 (0%)
Group 2: 1/46 (2%)
Group 3: 0/22 (0%)
MortalityGroup 1: 0/44 (0%)
Group 2: 0/46 (0%)
Group 3: 0/22 (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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