Evidence map›Paper›PMID 37679463›Full record

ArticleInternational journal of impotence research2024

Safety outcomes of the first Rigi10™ malleable penile prostheses implanted worldwide.

Steven K Wilson, Lexiaochuan Wen, Rafael Carrion, Francois Eid, Aaron Lentz, Bhavik Shah, Orhan Koca, Muhammed A M Hammad, Vijayant Govinda Gupta, Mohammad Hamdan

Open access · hybridAbstract read
In one paragraph

Article in International journal of impotence research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Update on penile prosthesis.Asian journal of andrology · 2026
    Review
  3. An update on penile prostheses: a narrative review.Asian journal of andrology · 2026
    Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
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

10 authors at 7 institutions in 2 countries.

Steven K WilsonInstitute for Urologic Excellence, La Quinta, CA, USA.
Lexiaochuan WenDepartment of Urology, Mayo Clinic, Rochester, MN, USA.ORCID http://orcid.org/0000-0001-8912-3899
Rafael CarrionDepartment of Urology, University of South Florida, Tampa, FL, USA.ORCID http://orcid.org/0000-0001-7388-9574
Francois EidAdvanced Urological Care, Norwell Health, New York, NY, USA.
Aaron LentzDepartment of Urologic Surgery, Duke University, Durham, NC, USA.ORCID http://orcid.org/0000-0002-7978-9205
Bhavik ShahAdvanced Urology, Snellville, GA, USA.
Orhan KocaDepartment of Urology, Medistate Kavacik Hospital, Istanbul, Turkey.
Muhammed A M HammadDepartment of Urology, University of California Irvine Health, Orange, CA, USA. mahammad@hs.uci.edu.ORCID http://orcid.org/0000-0001-5396-1364
Vijayant Govinda GuptaDepartment of Urology, Govinda Medicentre, New Delhi, India.
Mohammad HamdanDepartment of Urology, Royal Hospital, Amman, Jordan.
Advanced Dermatology · USDuke University · USJordan Hospital · JOMayo Clinic in Arizona · USNorthwell Health · USUniversity of California, Irvine · USUniversity of South Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Implantation of penile prosthesis is considered when conservative measures fail or are unacceptable to patients' wishing treatment for erectile dysfunction. In the United States (US), inflatable penile prostheses are more often used than malleable penile prostheses (MPP). Outside the US, the reverse is true because third-party reimbursement is not available, and MPP is considerably cheaper. Two American manufacturers make MPP; presently, a new manufacturer, Rigicon (Ronkonkoma NY), has recently begun to sell its MPP worldwide. Patient information forms submitted to the manufacturer between March 1, 2019, and December 8, 2022, were used to conduct an initial safety study for 605 first-time patients implanted with Rigicon10® by 46 physicians in 15 countries with a mean follow-up of 21.6 months. It has the same configuration of trimmable, paired silicone rods containing a twisted stainless-steel wire for bendability. However, it is available in six widths with hydrophilic coating compared to three widths offered by competitors. Revision or explantation was needed in 6 of 605 patients (0.99%) with half of those being removed for dissatisfaction (0.50%). Two (0.33%) suffered device infection and one (0.16%) required removal for erosion. Kaplan-Meier's statistical analysis showed three-year implant survival from revision = 99.2%. It demonstrated a comparable safety record with less than 1.00% of patients requiring reoperation.

Indexed as

Erectile DysfunctionPenile ImplantationPenile ProsthesisAdultAgedHumansMaleMiddle AgedPatient SatisfactionProsthesis DesignProsthesis FailureTreatment Outcome

Identifiers

PMID37679463
PMCPMC11624128
OpenAlexW4386527971

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.