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. 2022 Mar 29;2022(3):CD012867. doi: 10.1002/14651858.CD012867.pub3

Abt 2021.

Study characteristics
Methods Study design: open‐label, randomized controlled trial
Setting/country: single center/Switzerland
Dates when study was conducted: February 2014 to May 2017
Participants Inclusion criteria: men aged ≥ 40 years, TURP indicated, refractory to medical treatment or not willing to undergo or continue medical treatment, with prostate size 25–80 mL as measured by transabdominal US, with IPSS ≥ 8, with IPSS‐related QoL of ≥ 3 points, with a maximum urinary flow rate < 12 mL/second or urinary retention, and who provided written informed consent
Exclusion criteria: men with severe atherosclerosis, aneurysmatic changes or severe tortuosity in the aortic bifurcation or internal iliac arteries, acontractile detrusor, neurogenic lower urinary tract dysfunction, urethral stenosis, bladder diverticulum, bladder stone, allergy to intravenous contrast media, contraindication for magnetic resonance imaging, pre‐interventionally confirmed carcinoma of the prostate, and renal failure (glomerular filtration rate < 60 mL/minute)
Total number of participants randomly assigned: 103
Group A (PAE)

  • Number of all participants randomly assigned: 51

  • Age (years): 65.7 (SD 9.3)

  • Prostate volume (mL): 52.8 (SD 32.0)

  • PSA (ng/mL): 4.2 (SD 5.4)

  • IPSS: 19.38 (SD 6.37)

  • Qmax (mL/second): 7.47 (SD 4.14)


Group B (TURP)

  • Number of all participants randomly assigned: 52

  • Age (years): 66.1 (SD 9.8)

  • Prostate volume (mL): 56.5 (SD 31.1)

  • PSA (ng/mL): 4.5 (SD 5.6)

  • IPSS: 17.59 (SD 6.17)

  • Qmax (mL/second): 7.25 (SD 4.46)
Interventions Group A: PAE
Group B: monopolar TURP
Follow‐up: 2 years
Outcomes Primary outcome

  • Change from baseline in the IPSS


How measured: IPSS questionnaire
Time points measured: at baseline and 12 weeks
Time points reported: at baseline, 1 week, 6 weeks, 12 weeks, 6 months, 12 months, and 24 months
Secondary outcomes

  • IPSS at individual visits


How measured: IPSS questionnaire
Time points measured: at baseline, 1 week, 6 weeks, 12 weeks, 6 months, 12 months, and 24 months
Time points reported: at baseline, 1 week, 6 weeks, 12 weeks, 6 months, 12 months, and 24 months

  • Qmax/PVR/QoL/Chronic Prostatitis Symptoms Index/IIEF‐5


How measured: uroflowmetry/transabdominal US/IPSS questionnaire//Chronic Prostatitis Symptoms Index questionnaire/IIEF‐5 questionnaire
Time points measured: at baseline, 1 week, 6 weeks, 12 weeks, 6 months, 12 months, and 24 months
Time points reported: at baseline, 1 week, 6 weeks, 12 weeks, 6 months, 12 months, and 24 months
Safety outcomes: adverse events
How measured: modified Clavien system and common terminology criteria for adverse events
Time points measured: before intervention (baseline), during participants' stay in hospital, and at 1 week, 6 weeks, 12 weeks, 6 months, 12 months, and 24 months after surgery
Time points reported: likely cumulative incidence
Subgroup: none
Funding sources Grant from the research committee of St Gallen Cantonal Hospital
Declarations of interest None
Notes Protocol: NCT02054013
Language of publication: English
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "using the data management software SecuTrial, stratifying for patient age (< 70 or ≥ 70 years) and prostate volume (< 50 or ≥ 50 mL) through minimisation. SecuTrial was programmed by the clinical trials unit’s data manager, and automatic treatment allocation by SecuTrial was determined for individual patients without a predefined sequence after inclusion and entry of baseline characteristics by the investigators".
Allocation concealment (selection bias) Low risk Quote: "using the data management software SecuTrial, stratifying for patient age (< 70 or ≥ 70 years) and prostate volume (< 50 or ≥ 50 mL) through minimisation. SecuTrial was programmed by the clinical trials unit’s data manager, and automatic treatment allocation by SecuTrial was determined for individual patients without a predefined sequence after inclusion and entry of baseline characteristics by the investigators".
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "randomised, open‐label trial".
Blinding of outcome assessment (detection bias)
Subjective outcomes High risk Quote: "randomised, open‐label trial".
Blinding of outcome assessment (detection bias)
Objective outcomes Low risk Judgment: objective outcomes were likely not affected by lack of blinding.
Incomplete outcome data (attrition bias)
Urologic symptom scores/QoL High risk Judgments
Short term: 40/51 (78.4%) participants randomized in PAE and 50/52 (96.1%) in TURP were included in the analysis.
Long term: 34/51 (66.6%) participants randomized in PAE and 47/52 (90.3%) in TURP were included in the analysis.
Incomplete outcome data (attrition bias)
Major/minor adverse events Low risk Judgment: 48/51 (92.3%) participants randomized in PAE and 51/52 (98.0%) in TURP were included in the analysis.
Incomplete outcome data (attrition bias)
Retreatment Low risk Judgment: 48/51 (92.3%) participants randomized in PAE and 51/52 (98.0%) in TURP were included in the analysis.
Incomplete outcome data (attrition bias)
Erectile function High risk Judgments
Short term: 40/51 (78.4%) participants randomized in PAE and 50/52 (96.1%) in TURP were included in the analysis.
Long term: 34/51 (66.6%) participants randomized in PAE and 47/52 (90.3%) in TURP were included in the analysis.
Incomplete outcome data (attrition bias)
Ejaculatory disorders High risk Judgment: 25/51 (49.0%) participants randomized in PAE and 25/52 (48.0%) in TURP were included in the analysis.
Incomplete outcome data (attrition bias)
Acute urinary retention Low risk Judgment: 48/51 (92.3%) participants randomized in PAE and 51/52 (98.0%) in TURP were included in the analysis.
Incomplete outcome data (attrition bias)
Indwelling urinary catheter Low risk Judgment: 48/51 (92.3%) participants randomized in PAE and 51/52 (98.0%) in TURP were included in the analysis.
Incomplete outcome data (attrition bias)
Hospital stay Low risk Judgment: 48/51 (92.3%) participants randomized in PAE and 51/52 (98.0%) in TURP were included in the analysis.
Selective reporting (reporting bias) Unclear risk Judgment: protocol was published and study author shared the data (not shown in the article). But results that were not predefined in the protocol were reported. Data from bladder diary were not described in the methods section but they were described in the protocol.
Other bias Low risk Judgment: not detected.