Roehrborn 2013.
| Study characteristics | ||
| Methods |
Study design: multicentre randomized blinded trial Dates when study was conducted:February to December 2011 Setting: multicentre / International / outpatient Countries: 19 centres in US 14, Canada 2, Australia 3 |
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| Participants |
Inclusion criteria: men aged ≥ 50 years, provided informed consent, had no prior surgical treatment for BPH, and were required to undergo washouts of 2 weeks for alpha‐blocker, 3 months for 5a‐reductase inhibitor, and 3 days for anticoagulants. Admission to the study required ≥ IPSS 13, Qmax ≤ 12 mL/second with a 125 mL voided volume and a 30‐ to 80‐mL prostate volume Exclusion criteria: median lobe obstruction, retention, postvoid residual volume > 250 mL, active infection, PSA > 10 ng/mL (unless negative biopsy), cystolithiasis within 3 months, and bacterial prostatitis within 1 year Total number of participants randomly assigned: 206 Group A (PUL)
Group B (Sham)
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| Interventions |
Group A: PUL Transprostatic adjustable UroLift implants are permanently implanted to retract obstructing lateral lobes and expand the urethral lumen. After rigid cystoscopy is performed, the implant delivery device is inserted into the 20‐F sheath. Under cystoscopic visualization using a 2.9 mm 0‐degree lens, the delivery device is angled anterolaterally to compress the obstructive lobe. A 19‐gauge needle, housing a monofilament with metallic tab, is then deployed through the prostate lobe. As the needle is retracted, the tab engages the prostate capsule and the monofilament is tensioned. Finally, the urethral end‐piece is attached to the monofilament, which is then cut, delivering the in situ‐sized implant. Group B: sham Conducted with as similar an experience as possible to PUL. Follow‐up: 3 months |
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| Outcomes |
Urologic symptom scores How measured: Reduction in IPSS at 3 months after the PUL procedure was ≥ 25% greater than that of sham Time points measured: at baseline, 2 weeks, 1 month, and 3 months Time points reported: at baseline, 2 weeks, 1 month, and 3 months Subgroups: none Quality of Life How measured: IPSS‐QoL BPH II Time points measured: at baseline, 2 weeks, 1 month, and 3 months Time points reported: at baseline, 2 weeks, 1 month, and 3 months Subgroups: none Erectile function How measured: IIEF Time points measured: at baseline, 2 weeks, 1 month, and 3 months Time points reported: at baseline, 2 weeks, 1 month, and 3 months Subgroups: none Ejaculatory function How measured: MSHQ‐EjD Time points measured: at baseline, 2 weeks, 1 month, and 3 months Time points reported: at baseline, 2 weeks, 1 month, and 3 months Subgroups: none Retreatment How measured: number of participants requiring surgery Time points measured: not reported Time points reported: likely cumulative incidence Subgroups: none Major and minor adverse events (including acute urinary retention) How measured: adverse events Time points measured: not reported Time points reported: 3 months Subgroup: none Relevant outcomes not reported in this study
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| Funding sources | NeoTract, Fe/Male Health Centre | |
| Declarations of interest | NeoTract, Fe/Male Health Centre | |
| Notes |
Protocol: NCT01294150 Language of publication: English |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “Randomization was conducted just before treatment using permuted blocks of various sizes chosen at random through a central electronic data program.” |
| Allocation concealment (selection bias) | Low risk | Quote: “concealed through password protected electronic database program.” |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Judgement: we contacted with author, and they clarified the blinding of participants and outcome assessor. The personnel were not blinded. |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Quote: “An independent data monitoring committee assessed safety, and all AEs were adjudicated and assessed by an independent clinical events committee… A double‐blind was maintained through the 3‐month end point with the patient and questionnaire administrator blinded to randomisation. Blinding of participants was tested upon discharge and at each follow‐up to 3 months.” |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Judgement: objective outcomes were not likely affected by lack of blinding. |
| Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life | Low risk | Judgement: all participants who were randomized were included in analysis. |
| Incomplete outcome data (attrition bias) Major adverse events/minor adverse events | Low risk | Judgement: all participants who were randomized were included in analysis. |
| Incomplete outcome data (attrition bias) Retreatment | Low risk | Judgement: all participants who were randomized were included in analysis. |
| Incomplete outcome data (attrition bias) Erectile function | Low risk | Judgement: 132/140 (94.2%) of randomized participants in PUL and 65/66 (98.4%) in sham groups were included in the analysis. |
| Incomplete outcome data (attrition bias) Ejaculatory function | High risk | Judgement: 94/140 (67.1%) of randomized participants in PUL and 50/66 (75.7%) in sham groups were included in analysis. |
| Incomplete outcome data (attrition bias) Acute urinary retention | Low risk | Judgement: all participants who were randomized were included in analysis. |
| Incomplete outcome data (attrition bias) Indwelling catheter | Unclear risk | Judgement: not described in the study or protocol (described in a narrative statement). |
| Selective reporting (reporting bias) | Low risk | Judgement: review outcomes were prespecified in the protocol (NCT01294150) and were analyzed as planned. |
| Other bias | Low risk | Judgement: not detected. |