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IT Matters: The Erectile Restoration Registry

10. november 2026 opdateret af: Boston Scientific Corporation

The objective of the It MATTERS registry is to collect Real-World Data (RWD) to monitor the safe and effective use of commercially available Boston Scientific Corporation (BSC) penile prostheses

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

IT MATTERS is a prospective, multicenter, observational registry that is part of planned, active post market clinical follow-up (PMCF) activity associated with each device.

The study will include adult males who undergo penile prothesis implantation with a market approved BSC device to treat erectile dysfunction.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

450

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, Forenede Stater, 90033
        • USC Medical Center
      • Los Angeles, California, Forenede Stater, 99048
        • Tower Urology-Research Facility
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Hospital
      • Tampa, Florida, Forenede Stater, 33606
        • USF Health South Tampa Center for Advanced Healthcare
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago
      • Springfield, Illinois, Forenede Stater, 62702
        • SIU School of Medicine
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University Medical Center
    • Louisiana
      • Bossier City, Louisiana, Forenede Stater, 71111
        • Willis-Knighton Medical Center
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University in St. Louis
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27609
        • Duke University Medical Center
      • Salisbury, North Carolina, Forenede Stater, 28144
        • W.G. Hefner VA Medical Center
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Wake Forest University
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
      • Columbus, Ohio, Forenede Stater, 43212
        • Ohio State University Wexner Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University Hospital
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist Hospital
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • University of Utah
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin
  • Kina
      • Beijing, Kina, 100034
        • Peking University First Hospital
      • Shanghai, Kina, 200080
        • Shanghai General Hospital
      • Shanghai, Kina, 200127
        • Shanghai Jiaotong University School of Medicine Renji Hospital
  • Saudi Arabien
      • Dhahran, Saudi Arabien, 34465
        • Johns Hopkins Aramco Healthcare

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult males who meet the indications for surgical correction of erectile dysfunction will be enrolled.

Beskrivelse

Inclusion Criteria:

  1. ≥ 18 years of age.
  2. Males who are determined to be suitable candidates and scheduled to undergo surgical implantation of a market approved BSC penile prothesis by their physician.
  3. Willing and able to complete the informed consent process.
  4. Willing and able to comply with the follow-up requirements.

Exclusion Criteria:

  1. Males who are deemed by their physician as not suitable candidates for a penile prosthesis.
  2. In the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
BSC Penile Prothesis Recipients

Men for whom BSC Penile Prothesis is recommended.
Enhed: Tactra Malleable

The Tactra™ Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are suitable candidates for implantation procedure.

Enhed: Spectra™ Concealable Penile Prothesis

The Spectra Penile Prothesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery.

Enhed: AMS Ambicor™ Inflatable Penile Prosthesis

The AMS Ambicor inflatable penile prothesis intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence) in adult men who are determined to be suitable candidates for implantation surgery.

Enhed: AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump

The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).

Enhed: AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump

The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra
Tidsramme: Baseline to 6 months

The International Index of Erectile Function (IIEF) is a validated, widely used, multidimensional self-report instrument for the evaluation of erectile function. It consists of 15 items that assess sexual function in five domains: erectile function (Q1, 2, 3, 4, 5,15), orgasmic function (Q9,10), sexual desire (Q11,12), intercourse satisfaction (Q 6,7,8) and overall satisfaction (Q 13,14). A score of 0-5 is awarded to each of the 15 questions. The IIEF-15 total score is the sum of the ordinal responses to the 5 domains.

The erectile function (EF) domain is the most sensitive domain of the IIEF. IIEF-EF score ranges from 1 to 30 and is derived by scoring 0 (poorest function) to 5 (best function) on each of six questions function (Q1, 2, 3, 4, 5, 15). There are five categories of erectile function based on EF domain score: severe (1-10), moderate (11-16), mild to moderate (17-21), mild (22-25) and no ED (26-30).
Baseline to 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in depressive symptoms and overall sexual function at Post-Surgery, 6 months, and 12 months post device implantation compared to baseline, as measured by the PHQ-9 Depression Questionnaire and the IIEF: Total Score.
Tidsramme: Post-Surgery, 6 months, and 12 months

The Patient Health Questionnaire (PHQ) is a diagnostic tool for mental health disorders used by health care professionals. The PHQ contains: mood anxiety, alcohol, eating, and somatoform modules. The PHQ-9, is a validated tool specific to depression, scoring each of the 9 DSM-IV criteria. Scored from 0-27, the PHQ-9 is separated into five different diagnoses: minimal depression (0-4), mild depression (5-9), moderate depression (10-14), moderately severe depression (15-19), and severe depression (20-27).
Post-Surgery, 6 months, and 12 months
Change in quality of life at 6 months, and 12 months post device implantation compared to baseline as measured by the WPAI:GH Questionnaire.
Tidsramme: 6 months, and 12 months

The WPAI:GH (Work Productivity and Activity Impairment Questionnaire: General Health) is a validated tool that asks a series of questions about the effect of subject health problems, both physical and emotional, on their ability to work and perform regular activities. The WPAI:GH outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as following 6 questions: 1 = currently employed, 2 = hours missed due to health problems, 3 = hours missed other reasons, 4 = hours actually worked, 5 = degree health affected productivity while working, 6 = degree health affected regular activities. Scores are then multiplied by 100 to be expressed in percentages.
6 months, and 12 months
Change in erectile function at post-surgery, and 12 months post device implantation compared to baseline, as measured by the International Index of Erectile Function Domain (IIEF).
Tidsramme: Post-Surgery, and 12 months

The International Index of Erectile Function (IIEF) is a validated, widely used, multidimensional self-report instrument for the evaluation of erectile function. It consists of 15 items that assess sexual function in five domains: erectile function (Q1, 2, 3, 4, 5,15), orgasmic function (Q9,10), sexual desire (Q11,12), intercourse satisfaction (Q 6,7,8) and overall satisfaction (Q 13,14). A score of 0-5 is awarded to each of the 15 questions. The IIEF-15 total score is the sum of the ordinal responses to the 5 domains.

The erectile function (EF) domain is the most sensitive domain of the IIEF. IIEF-EF score ranges from 1 to 30 and is derived by scoring 0 (poorest function) to 5 (best function) on each of six questions function (Q1, 2, 3, 4, 5, 15). There are five categories of erectile function based on EF domain score: severe (1-10), moderate (11-16), mild to moderate (17-21), mild (22-25) and no ED (26-30).
Post-Surgery, and 12 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Device satisfaction at post-surgery, 6 months, and 12 months a measured by the Likert scale.
Tidsramme: Post-surgery, 6 months, and 12 months

The Likert scale has the options of Very Satisfied, Dissatisfied, Neither Satisfied nor Dissatisfied, Satisfied and Very Satisfied. Responses will be evaluated categorically.
Post-surgery, 6 months, and 12 months
Assess for outcomes and adverse events on AMS Tools at Post Procedure.
Tidsramme: Collected only at Post-Procedure

AMS tools will be assess by a physician survey as part of the post-procedure case report form.
Collected only at Post-Procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boston Scientific Corporation

Efterforskere

  • Ledende efterforsker: Mohit Khera, MD, Baylor College of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. august 2021

Primær færdiggørelse (Anslået)

1. januar 2031

Studieafslutning (Anslået)

1. december 2031

Datoer for studieregistrering

Først indsendt

11. december 2019

Først indsendt, der opfyldte QC-kriterier

13. december 2019

Først opslået (Faktiske)

16. december 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • U0670

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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