IT Matters: Le registre de restauration érectile
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Dhahran, Arabie Saoudite, 34465
- Johns Hopkins Aramco Healthcare
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Beijing, Chine, 100034
- Peking University First Hospital
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Shanghai, Chine, 200080
- Shanghai General Hospital
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Shanghai, Chine, 200127
- Shanghai Jiaotong University School of Medicine Renji Hospital
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California
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Los Angeles, California, États-Unis, 90095
- Ronald Reagan UCLA Medical Center
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Los Angeles, California, États-Unis, 90033
- USC Medical Center
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Los Angeles, California, États-Unis, 99048
- Tower Urology-Research Facility
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Florida
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Miami, Florida, États-Unis, 33136
- University of Miami Hospital
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Tampa, Florida, États-Unis, 33606
- USF Health South Tampa Center for Advanced Healthcare
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Illinois
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Chicago, Illinois, États-Unis, 60637
- University of Chicago
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Springfield, Illinois, États-Unis, 62702
- SIU School of Medicine
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Indiana University Medical Center
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Louisiana
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Bossier City, Louisiana, États-Unis, 71111
- Willis-Knighton Medical Center
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Washington University in St. Louis
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North Carolina
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Raleigh, North Carolina, États-Unis, 27609
- Duke University Medical Center
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Salisbury, North Carolina, États-Unis, 28144
- W.G. Hefner VA Medical Center
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Winston-Salem, North Carolina, États-Unis, 27103
- Wake Forest University
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic
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Columbus, Ohio, États-Unis, 43212
- Ohio State University Wexner Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
- Thomas Jefferson University Hospital
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Texas
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Houston, Texas, États-Unis, 77030
- Baylor College of Medicine
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Houston, Texas, États-Unis, 77030
- Houston Methodist Hospital
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Utah
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Salt Lake City, Utah, États-Unis, 84132
- University of Utah
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Washington
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Seattle, Washington, États-Unis, 98195
- University of Washington Medical Center
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Medical College of Wisconsin
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Adult males who meet the indications for surgical correction of erectile dysfunction will be enrolled.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra
Délai: Baseline to 6 months
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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.
Délai: Post-Surgery, 6 months, and 12 months
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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
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Change in quality of life at 6 months, and 12 months post device implantation compared to baseline as measured by the WPAI:GH Questionnaire.
Délai: 6 months, and 12 months
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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
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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).
Délai: Post-Surgery, and 12 months
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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
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Device satisfaction at post-surgery, 6 months, and 12 months a measured by the Likert scale.
Délai: Post-surgery, 6 months, and 12 months
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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.
Délai: Collected only at Post-Procedure
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AMS tools will be assess by a physician survey as part of the post-procedure case report form. |
Collected only at Post-Procedure
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mohit Khera, MD, Baylor College of Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- U0670
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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