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

Bdesha 1994.

Study characteristics
Methods Study design: prospective, randomized parallel study
Study dates: study dates not available
Setting: outpatient, single‐center, national
Country: United Kingdom
Participants Inclusion criteria: men with:
  • Symptoms of prostatism for at least 6 months

  • World Health Organization's symptom score > 14

  • Residual urine volume of at least 50 mL

  • Peak flow rate < 15 mL/s


Exclusion criteria: men with:
  • Malignant glands

  • Impaired renal function

  • History of prostatic surgery

  • Residual urine volumes > 200 mL

  • Large glands (length from bladder neck to proximal veru > 40 mm)

  • Large obstructing middle lobes

  • Acute urinary retention

  • Coexisting urinary tract disease


Total number of participants randomized: 40
Group 1: n = 22 microwave treatment
  • World Health Organization's symptom score, mean (95% CI): 30 (25.2 – 34.8)

  • AUA symptom score, mean (95% CI): 19.2 (16.3 ‐ 22.1)

  • Age, mean: 63.7 years (no 95% CI or SD available)

  • Qmax, mean (95% CI): 12.3 mL/s (10.7 – 13.9)

  • Residual vol, mean (95%CI): 104 mL (85 ‐ 125)


Group 2: n = 18 sham treatment
  • World Health Organization's symptom score, mean (95% CI): 31 (25.5 – 36.5)

  • AUA symptom score, mean (95% CI): 18.8 (16.0 ‐ 21.7)

  • Age, mean: 62.6 years (no 95% CI or SD available)

  • Qmax, mean (95% CI): 10.8 mL/s (9.2 – 12.4)

  • Residual vol, mean (95% CI): 80 mL (57 ‐ 103)

Interventions Group 1 (n = 22):TUMT
LEO Microthermer was used in all participants in a single active 90‐min treatment. This machine delivers a maximum power output of 20 watts at 915 MHz. and incorporates an automatic power cut‐off, which operates if the rectal temperature increases to > 42.5 ºC
Group 2 (n = 18) Sham: Same procedure, participants received 90‐min sham treatment with no power delivered. Participants received a heating pad to simulate hyperthermia
Co‐interventions: topical lidocaine gel was used alongside flexible cystoscopy to exclude a coexisting lower urinary tract pathological condition and to measure the prostate
Outcomes Urologic symptom scores
How measured: AUA symptom score and WHO symptom score. Also as the proportion of participants with a decrease of 50% or more in symptom scores.
Time points measured: baseline and 3 months
Time points reported: baseline and 3 months
Subgroups: none
Minor and major adverse events / erectile function / ejaculatory function
How measured: Narratively (including sexual adverse events)
Time points measured: not reported
Time points reported: not reported
Subgroups: none
Acute urinary retention
How measured: narratively
Time points measured: not reported
Time points reported: not reported
Subgroups: none
Retreatment
How measured: narratively (TURP after sham)
Time points measured: not reported
Time points reported: not reported
Subgroups: none
Relevant outcomes not reported in this study
  • Quality of life

  • Indwelling urinary catheter

Funding sources Not available
Declarations of interest Not available
Notes Study unblinded with cross‐over at 3 months and follow‐up to 1 year. 16 participants in the sham group were offered active treatment at 3 months (this was not considered retreatment). No contact information available.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information available. Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’.
Allocation concealment (selection bias) Unclear risk The study describes only "sealed envelope." Insufficient information to permit judgment of ‘Low risk’ or ‘High risk’.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind study. Participants and study personnel were blinded.
Blinding of outcome assessment (detection bias)
Objective outcomes Low risk Double‐blind study. Participants and study personnel were blinded.
Blinding of outcome assessment (detection bias)
Subjective outcomes Low risk Double‐blind study. Participants and study personnel were blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk Only 2 participants (10%) in the sham group were lost at follow‐up.
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 identified.