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IT Matters: het register voor erectieherstel

10 november 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

450

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Mannelijk

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
BSC Penile Prothesis Recipients

Men for whom BSC Penile Prothesis is recommended.
Apparaat: 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.

Apparaat: 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.

Apparaat: 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.

Apparaat: 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).

Apparaat: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: 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.
Tijdsspanne: 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).
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Device satisfaction at post-surgery, 6 months, and 12 months a measured by the Likert scale.
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Boston Scientific Corporation

Onderzoekers

  • Hoofdonderzoeker: Mohit Khera, MD, Baylor College of Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 augustus 2021

Primaire voltooiing (Geschat)

1 januari 2031

Studie voltooiing (Geschat)

1 december 2031

Studieregistratiedata

Eerst ingediend

11 december 2019

Eerst ingediend dat voldeed aan de QC-criteria

13 december 2019

Eerst geplaatst (Werkelijk)

16 december 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

10 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • U0670

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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