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. 2021 Jun 28;2021(6):CD004135. doi: 10.1002/14651858.CD004135.pub4

D'Ancona 1998.

Study characteristics
Methods Study design: parallel‐group randomized trial
Study dates: January 1994 to August 1995
Setting: outpatient
Country: Netherlands
Participants Inclusion criteria: men:
  • 45 years old or older

  • Clinically unequivocal benign prostate

  • Prostatic length 25 to 50 mm – volume 30 to 100 cm3

  • Symptoms > 3 months

  • Madsen symptom score 8 or greater

  • PFR peak flow rate 15 mL per second

  • Minimum voided volume of 100 mL

  • Post‐void residual 350 mL or less

  • Willingness and ability to comply with the study follow‐up


Exclusion criteria:
  • Neurogenic disorders that may affect bladder function

  • Prostatic carcinoma

  • Prior surgery of the prostate

  • Microwave possible sensitive implants (pacemaker or hip prosthesis)

  • Diabetic neuropathy

  • Urinary retention requiring an indwelling catheter

  • Renal impairment

  • Obstructed bladder neck due to an enlarged median lobe of the prostate

  • Those who were on medication prescribed for treatment of the prostate or bladder


Sample size: 52 participants were randomized
Group 1: n = 31 transurethral microwave thermotherapy (TUMT)
  • Age, mean (SD): 69.6 ± 8.5

  • Prostate volume (cc), mean (SD): 45 ± 15

  • IPSS score, Mean (SD): 16.7 ± 5.6

  • Qmax (mL/s), Mean (SD): 9.3 ± 3.4

  • Residual volume, mL (SD): 91 ± 105


Group 1: n = 21 transurethral resection of the prostate (TURP)
  • Age, mean (SD): 69.3 ± 5.9

  • Prostate volume (cc), mean (SD): 43 ± 12

  • IPSS score, Mean (SD): 18.3 ± 6.3

  • Qmax (mL/s), Mean (SD): 10.0 ± 6.1

  • Residual volume, mL (SD): 58 ± 78

Interventions Group 1 (n = 31): TUMT
Delivered using Prostatron device with software version 2.5, for 60 minutes increasing thermal dose up to 70 watts. Urethral and rectal thermal sensors provided feedback to prevent harms. Preparation included 100 mg diclofenac suppository and 2 mg of midazolam intramuscularly. If necessary, further intravenous sedation was administered. All participants left with an indwelling urinary catheter
Group 2 (n = 21): TURP
Performed by 2 experienced urologists with use of spinal anesthesia. The surgical capsule was reached circumferentially from the bladder neck to the verumontanum using 24 Ch. Resectoscopes
Co‐interventions: not described
Outcomes Urologic symptom scores
How measured: Madsen symptom score and IPSS
Time points measured: 1, 3, 6 and 12 months
Time points reported: 3, 6, 12 months
Subgroups: none
Major and minor adverse events
How measured: episodes of urinary tract infection, hematuria
Time points measured: not reported
Time points reported: not reported
Subgroups: none
Retreatment
How measured: “repeat treatment”
Time points measured: not reported
Time points reported: not reported
Subgroups: none
Indwelling urinary catheter
How measured: days of catheterization
Time points measured: not reported
Time points reported: median days and range
Subgroups: none
Relevant outcomes not reported in this study:
  • Quality of life

  • Erectile function

  • Ejaculatory function

  • Acute urinary retention (all participants were routinely catheterized)

Funding sources Not available
Declarations of interest Not available
Notes No contact information available.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “Participants were randomised”.
Comment: No information available. Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’.
Allocation concealment (selection bias) Unclear risk Quote: “Participants were randomised.”
Comment: No information available. Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’.
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and personnel were not blinded.
Blinding of outcome assessment (detection bias)
Objective outcomes Low risk Participants and personnel were not blinded. Outcomes are unlikely to be affected by lack of blinding.
Blinding of outcome assessment (detection bias)
Subjective outcomes High risk Participants and personnel were not blinded.
Incomplete outcome data (attrition bias)
All outcomes High risk Outcome data were available for 44/52 participants at 1 year follow‐up, 2 were lost in the TURP group (bladder cancer and bladder neck sclerosis) and 6 in the TUMT group (1 underwent TURP, 1 died, 1 lost to follow up, 3 refused follow‐up). Unbalanced attrition.
Selective reporting (reporting bias) Unclear risk No protocol available. Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’.
Other bias Low risk No other sources of bias were detected.