Evidence map›Paper›PMID 35641601›Full record

Trial reportProstate cancer and prostatic diseases2022

The EXPANDER-1 trial: introduction of the novel Urocross™ Expander System for treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Henry H Woo, Chi-Ping Huang, William J Huang, Yi-Huei Chang, Chi-Shun Lien, Archil Chkhotua, Dean S Elterman

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Prostate cancer and prostatic diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
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  9. Best of 2023 in Prostate Cancer and Prostatic Diseases.Prostate cancer and prostatic diseases · 2024
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 4 countries.

Henry H WooCollege of Health and Medicine, Australian National University, Canberra, ACT, Australia and SAN Prostate Centre of Excellence, Sydney Adventist Hospital, Wahroonga, NSW, Australia. hwoo@urologist.net.au.ORCID 0000-0003-4099-0339
Chi-Ping HuangDepartment of Urology, China Medical University and Hospital, Taichung, Taiwan.
William J HuangDepartment of Urology, Taipei Veterans General Hospital; School of Medicine, National Yang Ming Chiao Tung University, Taipei City, Taiwan.
Yi-Huei ChangDepartment of Urology, China Medical University and Hospital, Taichung, Taiwan.
Chi-Shun LienDepartment of Urology, China Medical University and Hospital, Taichung, Taiwan.
Archil ChkhotuaNational Center of Urology, Tbilisi, Georgia.
Dean S EltermanDivision of Urology, University Health Network, University of Toronto, Toronto, ON, Canada.ORCID 0000-0003-1507-7783
China Medical University · TWAustralian National University · AUNational Cancer Center of Georgia · GENational Yang Ming Chiao Tung University · TWUniversity Health Network · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo demonstrate the safety and feasibility of the Urocross Expander System (formerly branded as XFLO Expander System), an implantable nitinol tissue expander to trea t patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). MATERIALS AND

methodsMen of 50 years or older were eligible to participate in the international, prospective, three-arm, open-label EXPANDER-1 trial if they had a prostate volume between 30 and 80 cc, prostatic urethra length between 20 and 60/80 mm, international prostate symptom score (IPSS) > 13, peak urinary flow (Qmax) < 12 mL/s, post-void residual (PVR) urine volume < 250 mL and quality of life (QoL) score ≥ 3. Patients had pre-assigned implant indwell times (1, 6, and 12 months for Arm-1, Arm-2 and Arm-3 respectively) with follow-up through 6 months (Arm-1) and 3 years (Arm-2 and Arm-3) post-retrieval.

resultsOutcome from treated subjects with their 6-month post-retrieval will be presented in this manuscript, as data collection from longer-term follow-up is ongoing. As of May 24, 2021, 39 and 22 men (mean age: 65), respectively, had implants successfully deployed and retrieved without any complications. No cases of implant encrustation were observed. Device- and procedure-related adverse events were predominantly mild to moderate in severity. Three SAEs were reported. Only one patient required catheterization post-implant for more than three days. Improvements in clinical parameters such as IPSS, QoL, PVR and Qmax as well as sexual function were observed.

conclusionsPreliminary results demonstrate that the Urocross Expander System is a feasible and safe procedure for treating BPH/LUTS. A strong signal of efficacy justifies further evaluation of this PRostatic Urethral Expansion (PURE) procedure. Negative features of earlier generations of prostatic implants such as biocompatibility, migrations and encrustation have possibly been overcome.

Indexed as

Lower Urinary Tract SymptomsProstatic HyperplasiaProstatic NeoplasmsAgedHumansMaleProspective StudiesQuality of LifeTissue Expansion DevicesTreatment Outcome

Identifiers

PMID35641601
PMCPMC9385491
OpenAlexW4282031579

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.