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. 2021 Jul 15;2021(7):CD013656. doi: 10.1002/14651858.CD013656.pub2

Wagrell 2002.

Study characteristics
Methods Study design: prospective, randomized study
Study dates: October 1998 to November 1999
Setting: outpatient, multicenter center, international
Country: Scandinavia and United States of America
Participants Inclusion criteria: men with:

  • symptomatic BPH

  • International Prostate Symptom Score (IPSS) of 13 or greater

  • prostate volume of 30 to 100 mL

  • and peak urinary flow rate (Qmax) less than 13 mL/s


Exclusion criteria: not reported
Total number of participantsrandomized: 154
Group 1: n = 103 Microwave Treatment

  • Age, mean (SD): 67 (8) years

  • Weight, mean (SD): 83 (15) kg

  • Height, mean (SD): 178 (6) cm

  • Residual urine volume, mean (SD): 106 (77) mL

  • Detrusor (voiding) pressure, mean (SD): 73.7 (29.7) cm H2O

  • Maximal free urinary flow rate, mean (SD): 7.6 (2.7) mL/s

  • PSA, mean (SD): 3.3 (2.2) g/L

  • Prostate volume as determined by TRUS, mean (SD): 48.9 (15.8) cm3

  • IPSS, mean (SD): 21.0 (5.4)

  • Bother score, mean (SD): 4.3 (1.0)


Group 2: n = 51 Transurethral resection of the prostate

  • Age, mean (SD): 69 (8) years

  • Weight, mean (SD): 81 (11) kg

  • Height, mean (SD): 177 (6) cm

  • Residual urine volume, mean (SD): 94 (82) mL

  • Detrusor (voiding) pressure, mean (SD): 79.4 (35.3) cm H2O

  • Maximal free urinary flow rate, mean (SD): 7.9 (2.7) mL/s

  • PSA, mean (SD): 3.6 (2.7) g/L

  • Prostate volume as determined by TRUS, mean (SD): 52.7 (17.3) cm3

  • IPSS, mean (SD): 20.4 (5.9)

  • Bother score, mean (SD): 4.2 (1.1)
Interventions Group 1 (n = 103) TUMT
ProstaLund Feedback measured temperatures and were continuously displayed on the device computer. Using the heat equation, the device also calculates the extent of the coagulation necrosis continuously during the treatment, stopping at 55 °C.
Group 2 (n = 51): TURP
TURP was performed as a clinical standard inpatient procedure according to the routines at each center.
Co‐interventions: A washout period of at least 6 weeks preceded the treatment for patients who had been using any alpha‐receptor blocker or finasteride.
Outcomes Urologic symptom scores
How measured: International Prostate Symptom Score (IPSS)
Time points measured: baseline, 3, 6, 12, 24, 36, 48, and 60 months.
Time points reported: baseline, 3, 6, 12, 24, 36, 48, and 60 months.
Subgroups: none
Quality of Life
How measured: QoL domain of IPSS score
Time points measured: baseline, 3, 6, 12, 24, 36, 48, and 60 months.
Time points reported: baseline, 3, 6, 12, 24, 36, 48, and 60 months.
Subgroups: none
Mayor adverse events
How measured: All adverse events occurring during the entire study period were reported. A serious adverse event was defined according to International Congress on Harmonization as any untoward medical event that resulted in death, was life‐threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was cancer, or required intervention to prevent permanent damage to body functions or structure.
Time points measured: during treatment and up to 12 months.
Time points reported: during treatment and up to 12 months.
Subgroups: none
Minor adverse events (includes acute urinary retention and erectile dysfunction)
How measured: not reported
Time points measured: during treatment or up to 12 months, and from 12 to 60 months.
Time points reported: during treatment or up to 12 months, and from 12 to 60 months.
Subgroups: none
Indwelling urinary catheter
How measured: time with the catheter
Time points measured: after the procedure
Time points reported: after the procedure
Subgroups: none
Retreatment
How measured: number of participants with additional medical or surgical treatment
Time points measured: after the procedure
Time points reported: after the procedure
Subgroups: none
Relevant outcomes not reported in this study

  • Ejaculatory dysfunction
Funding sources Funded by ProstaLund.
Declarations of interest Wagrell L, Schelin S, Larson TR, and Mattiasson A were paid consultants to the sponsor of this study.
Notes A total of 154 patients were included on an intention‐to‐treat basis. Eight patients (5 in the TURP and 3 in the PLFT group) were withdrawn before treatment, resulting in a total of 146 treated patients; 100 in the PLFT arm and 46 in the TURP arm.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information about the sequence generation process to permit judgement of ‘Low risk’ or ‘High risk’.
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’.
Quote: “The randomisation ratio between PLFT and TURP was 2:1.”
Blinding of participants and personnel (performance bias)
Subjective outcomes High risk Whereas blinding was not mentioned, the interventions were visibly different (surgery versus outpatient procedure).
The subjective outcomes were likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias)
Subjective outcomes High risk Whereas blinding was not mentioned, the interventions were visibly different (surgery versus outpatient procedure).
The subjective outcomes were likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias)
Objective outcomes Low risk Whereas blinding was not mentioned, the interventions were visibly different (surgery versus outpatient procedure).
The objective outcomes were unlikely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias)
Urologic symptom scores/Quality of life Low risk 12 months: balanced attrition, and outcome data was available for 133/154 (86%).
Judgement: low risk of bias (short term).
24 months: outcome data was available for 79/103 in the TUMT group and 39/51 in the TURP group (76%).
36 months: outcome data was available for 69/103 in the TUMT group and 35/51 in the TURP group.
60 months: outcome data was available for 62/103 in the TUMT group and 34/51 in the TURP group.
Judgement: high risk of bias (long term).
Incomplete outcome data (attrition bias)
Major adverse events/minor adverse events Low risk 12 months: balanced attrition, and outcome data was available for 133/154 (86%).
Judgement: low risk of bias (short term data only).
Incomplete outcome data (attrition bias)
Retreatment High risk 24 months: outcome data was available for 79/103 in the TUMT group and 39/51 in the TURP group (76%).
36 months: outcome data was available for 69/103 in the TUMT group and 35/51 in the TURP group.
60 months: outcome data was available for 62/103 in the TUMT group and 34/51 in the TURP group.
Judgement: high risk of bias (long term).
Incomplete outcome data (attrition bias)
Erectile function Low risk 12 months: balanced attrition, and outcome data was available for 133/154 (86%).
Judgement: low risk of bias (short term).
24 months: outcome data was available for 79/103 in the TUMT group and 39/51 in the TURP group (76%).
36 months: outcome data was available for 69/103 in the TUMT group and 35/51 in the TURP group.
60 months: outcome data was available for 62/103 in the TUMT group and 34/51 in the TURP group.
Judgement: high risk of bias (long term).
Incomplete outcome data (attrition bias)
Acute urinary retention Low risk 12 months: balanced attrition, and outcome data was available for 133/154 (86%).
Judgement: low risk of bias (short term data only).
Incomplete outcome data (attrition bias)
Indwelling catheter Unclear risk Not fully measured (narrative statement).
Selective reporting (reporting bias) Unclear risk No protocol available. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’.
Other bias Low risk No other sources of bias were identified.