Evidence map›Paper›PMID 24680796›Full record

Trial reportThe American journal of medicine2014

Randomized controlled trial of sildenafil for preventing recurrent ischemic priapism in sickle cell disease.

Arthur L Burnett, Uzoma A Anele, Irene N Trueheart, John J Strouse, James F Casella

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The American journal of medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
6.8field-weighted citation impact, top 2% 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

30 citing papers in PubMed, 4 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Treatments for priapism in boys and men with sickle cell disease.The Cochrane database of systematic reviews · 2020
    Pooled it
  4. Treatments for priapism in boys and men with sickle cell disease.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Epidemiology and treatment of priapism in sickle cell disease.Hematology. American Society of Hematology. Education Program · 2022
    Review
  12. Rare emergency in children: Priapism and stepwise treatment approach.Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES · 2022
    Article
  13. Article
  14. Article
  15. cGMP modulation therapeutics for sickle cell disease.Experimental biology and medicine (Maywood, N.J.) · 2019
    Review
  16. THE SCIENCE AND PRACTICE OF ERECTION PHYSIOLOGY: STORY OF A REVOLUTIONARY GASEOUS MOLECULE.Transactions of the American Clinical and Climatological Association · 2019
    Review
  17. Article
  18. Advances in the understanding of priapism.Translational andrology and urology · 2017
    Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Arthur L BurnettThe James Buchanan Brady Urological Institute and Department of Urology, The Johns Hopkins School of Medicine, Baltimore, Md. Electronic address: aburnet1@jhmi.edu.
Uzoma A AneleThe James Buchanan Brady Urological Institute and Department of Urology, The Johns Hopkins School of Medicine, Baltimore, Md.
Irene N TrueheartThe James Buchanan Brady Urological Institute and Department of Urology, The Johns Hopkins School of Medicine, Baltimore, Md.
John J StrouseDivision of Pediatric Hematology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.
James F CasellaDivision of Pediatric Hematology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.
Johns Hopkins University · USJohns Hopkins Medicine · US

Funding

Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
Sickle cell scholar componentU54HL090515 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI CASELLA, JAMES F · 2008 to 2011
$3.8M
NCATS NIH HHS UL1 TR001079NHLBI NIH HHS 1U54HL090515NHLBI NIH HHS U54 HL090515
6 · The paper itself

Abstract

backgroundSuccessful preventive therapy for ischemic priapism, a disorder of penile erection with major physical and psychologic consequences, is limited. We conducted a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of sildenafil by a systematic dosing protocol to prevent recurrent ischemic priapism associated with sickle cell disease.

methodsThirteen patients with sickle cell disease reporting priapism recurrences at least twice weekly were randomized to receive sildenafil 50 mg or placebo daily, unassociated with sleep or sexual activity, for 8 weeks, followed by open-label use of this sildenafil regimen for an additional 8 weeks.

resultsPriapism frequency reduction by 50% did not differ between sildenafil and placebo groups by intention-to-treat or per protocol analyses (P = 1.0). However, during open-label assessment, 5 of 8 patients (62.5%) by intention-to-treat analysis and 2 of 3 patients (66.7%) by per protocol analysis met this primary efficacy outcome. No significant differences were found between study groups in rates of adverse effects, although major priapism episodes were decreased 4-fold in patients monitored "on-treatment."

conclusionsSildenafil use by systematic dosing may offer a strategy to prevent recurrent ischemic priapism in patients with sickle cell disease.

Indexed as

AdolescentAdultAnemia, Sickle CellDouble-Blind MethodHumansIschemiaMaleMiddle AgedPhosphodiesterase 5 InhibitorsPiperazinesPriapismProspective StudiesPurinesRecurrenceSildenafil CitrateSulfonesPhosphodiesterase 5 InhibitorsPiperazinesPurinesSildenafil CitrateSulfonesErectile dysfunctionErectionNitric oxidePhosphodiesterase type 5

Identifiers

PMID24680796
PMCPMC4085689
OpenAlexW2026701273

What OpenQuestion holds

Textmetadata
LicenceTDM
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.