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

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 less than 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 > 40mm)

  • Large obstructing middle lobes

  • Acute urinary retention

  • Coexisting urinary tract disease


Total number of participantsrandomized: 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‐minute treatment using a LEO Microthermer. This machine delivers a maximum power output of 20 watts at 915 MHz and incorporates an automatic power cutoff, which operates if the rectal temperature increases to greater than 42.5C.
Group 2 (n = 18) sham: Same procedure, however 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.
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: not reported
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 (narrative description)

Funding sources Not available
Declarations of interest Not available
Notes Study unblinded with cross‐over at 3 months and follow‐up to 1 year. No contact information available.
Protocol: not available
Language of publication: English
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information available. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’.
Allocation concealment (selection bias) Unclear risk The study describes only “sealed envelope.” Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’.
Blinding of participants and personnel (performance bias)
Subjective outcomes Low risk Quote: “The patients were also asked which treatment they thought they had received: 19 of those who had received microwave treatment answered correctly, while half the patients who had received sham treatment thought they had received a real treatment.”
Judgement: Participants and personnel administrating the questionnaires were blinded.
Blinding of outcome assessment (detection bias)
Subjective outcomes Low risk Double‐blind study. Participants and study personnel were blinded (see above).
Blinding of outcome assessment (detection bias)
Objective outcomes Low risk Double‐blind study. Participants and study personnel were blinded (see above).
Incomplete outcome data (attrition bias)
Urologic symptom scores/Quality of life Low risk Only two participants (10%) in the sham group were lost at follow‐up.
Incomplete outcome data (attrition bias)
Major adverse events/minor adverse events Low risk Only two participants (10%) in the sham group were lost at follow‐up.
Incomplete outcome data (attrition bias)
Retreatment Low risk Only two participants (10%) in the sham group were lost at follow‐up.
Incomplete outcome data (attrition bias)
Erectile function Low risk Only two participants (10%) in the sham group were lost at follow‐up.
Incomplete outcome data (attrition bias)
Ejaculatory function Low risk Only two participants (10%) in the sham group were lost at follow‐up.
Incomplete outcome data (attrition bias)
Acute urinary retention Low risk Only two participants (10%) in the sham group were lost at follow‐up.
Incomplete outcome data (attrition bias)
Indwelling catheter Unclear risk Only two participants (10%) in the sham group were lost at follow‐up. 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.