IT Matters: The Erectile Restoration Registry
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
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90095
- Ronald Reagan UCLA Medical Center
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Los Angeles, California, Forente stater, 90033
- USC Medical Center
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Los Angeles, California, Forente stater, 99048
- Tower Urology-Research Facility
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Florida
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Miami, Florida, Forente stater, 33136
- University of Miami Hospital
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Tampa, Florida, Forente stater, 33606
- USF Health South Tampa Center for Advanced Healthcare
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Illinois
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Chicago, Illinois, Forente stater, 60637
- University of Chicago
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Springfield, Illinois, Forente stater, 62702
- SIU School of Medicine
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Indiana University Medical Center
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Louisiana
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Bossier City, Louisiana, Forente stater, 71111
- Willis-Knighton Medical Center
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Missouri
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St Louis, Missouri, Forente stater, 63110
- Washington University in St. Louis
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North Carolina
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Raleigh, North Carolina, Forente stater, 27609
- Duke University Medical Center
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Salisbury, North Carolina, Forente stater, 28144
- W.G. Hefner VA Medical Center
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Winston-Salem, North Carolina, Forente stater, 27103
- Wake Forest University
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic
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Columbus, Ohio, Forente stater, 43212
- Ohio State University Wexner Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Thomas Jefferson University Hospital
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Texas
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Houston, Texas, Forente stater, 77030
- Baylor College of Medicine
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Houston, Texas, Forente stater, 77030
- Houston Methodist Hospital
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Utah
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Salt Lake City, Utah, Forente stater, 84132
- University of Utah
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Washington
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Seattle, Washington, Forente stater, 98195
- University of Washington Medical Center
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- Medical College of Wisconsin
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Beijing, Kina, 100034
- Peking University First Hospital
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Shanghai, Kina, 200080
- Shanghai General Hospital
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Shanghai, Kina, 200127
- Shanghai Jiaotong University School of Medicine Renji Hospital
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Dhahran, Saudi-Arabia, 34465
- Johns Hopkins Aramco Healthcare
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Adult males who meet the indications for surgical correction of erectile dysfunction will be enrolled.
Beskrivelse
Inclusion Criteria:
- ≥ 18 years of age.
- Males who are determined to be suitable candidates and scheduled to undergo surgical implantation of a market approved BSC penile prothesis by their physician.
- Willing and able to complete the informed consent process.
- Willing and able to comply with the follow-up requirements.
Exclusion Criteria:
- Males who are deemed by their physician as not suitable candidates for a penile prosthesis.
- In the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
BSC Penile Prothesis Recipients
Men for whom BSC Penile Prothesis is recommended. |
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. 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. 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. The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
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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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mohit Khera, MD, Baylor College of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- U0670
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