Questioni IT: il registro del restauro erettile
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
-
-
-
Dhahran, Arabia Saudita, 34465
- Johns Hopkins Aramco Healthcare
-
-
-
-
-
Beijing, Cina, 100034
- Peking University First Hospital
-
Shanghai, Cina, 200080
- Shanghai General Hospital
-
Shanghai, Cina, 200127
- Shanghai Jiaotong University School of Medicine Renji Hospital
-
-
-
-
California
-
Los Angeles, California, Stati Uniti, 90095
- Ronald Reagan UCLA Medical Center
-
Los Angeles, California, Stati Uniti, 90033
- USC Medical Center
-
Los Angeles, California, Stati Uniti, 99048
- Tower Urology-Research Facility
-
-
Florida
-
Miami, Florida, Stati Uniti, 33136
- University of Miami Hospital
-
Tampa, Florida, Stati Uniti, 33606
- USF Health South Tampa Center for Advanced Healthcare
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60637
- University of Chicago
-
Springfield, Illinois, Stati Uniti, 62702
- SIU School of Medicine
-
-
Indiana
-
Indianapolis, Indiana, Stati Uniti, 46202
- Indiana University Medical Center
-
-
Louisiana
-
Bossier City, Louisiana, Stati Uniti, 71111
- Willis-Knighton Medical Center
-
-
Missouri
-
St Louis, Missouri, Stati Uniti, 63110
- Washington University in St. Louis
-
-
North Carolina
-
Raleigh, North Carolina, Stati Uniti, 27609
- Duke University Medical Center
-
Salisbury, North Carolina, Stati Uniti, 28144
- W.G. Hefner VA Medical Center
-
Winston-Salem, North Carolina, Stati Uniti, 27103
- Wake Forest University
-
-
Ohio
-
Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic
-
Columbus, Ohio, Stati Uniti, 43212
- Ohio State University Wexner Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19107
- Thomas Jefferson University Hospital
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- Baylor College of Medicine
-
Houston, Texas, Stati Uniti, 77030
- Houston Methodist Hospital
-
-
Utah
-
Salt Lake City, Utah, Stati Uniti, 84132
- University of Utah
-
-
Washington
-
Seattle, Washington, Stati Uniti, 98195
- University of Washington Medical Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, Stati Uniti, 53226
- Medical College of Wisconsin
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Adult males who meet the indications for surgical correction of erectile dysfunction will be enrolled.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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). |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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.
Lasso di tempo: 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.
Lasso di tempo: 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).
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Device satisfaction at post-surgery, 6 months, and 12 months a measured by the Likert scale.
Lasso di tempo: 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.
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mohit Khera, MD, Baylor College of Medicine
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- U0670
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .