Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 62 for:    Recruiting, Not yet recruiting, Available Studies | Impotence

Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction (PHOENIX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03849586
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
European Association of Urology Research Foundation

Brief Summary:
Prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using Penile Prosthesis Implants (PPIs).

Condition or disease
Erectile Dysfunction

Detailed Description:

This will be a prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using Penile Prosthesis Implants (PPIs). The data collection will be undertaken from multiple centres in Europe. The participation will be by open invitation from the European Association of Urology (EAU) Section of Genitourinary Reconstructive Surgeons (ESGURS) to all its members, along with other urologists undertaking these procedures.

There will be no restriction on the number of patients enrolled per centre as long as they are consecutive. The aim is to have a long term collection of the dataset from as many centres as possible. An initial assessment for the robustness of the data collection and first clinical evaluation of the data collected will be performed 1 and 2 years after recruitment of the first patient by a nominated steering committee. Thereafter, the evaluations will be performed every 2 years until the end of Registry (10 years after the first patient was enrolled).


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Prospective Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : April 2029
Estimated Study Completion Date : April 2029

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Patient Satisfaction score [ Time Frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery ]
    Patient Satisfaction score is defined as the mean patient satisfaction score as indicated by the Modified Patient EDITS Questionnaire. All items on the Patient EDITS will be scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The mean satisfaction score for each patient will be calculated. To place scores in an easily interpretable metric, each mean score will be multiplied by 25 so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 extremely high treatment satisfaction).


Secondary Outcome Measures :
  1. Partner Satisfaction score [ Time Frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery ]
    Partner Satisfaction score is defined as the mean partner satisfaction score as indicated by the Modified Partner EDITS Questionnaire. All items on the Partner EDITS will be scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The mean satisfaction score for the partner will be calculated. To place scores in an easily interpretable metric, each mean score will be multiplied by 25 so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 extremely high treatment satisfaction).

  2. Patient satisfaction rate [ Time Frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery ]
    The number of patients with an EDITS score ≥ 50 compared to the total number of patients

  3. Partner satisfaction rate [ Time Frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery ]
    The number of partners with an EDITS score ≥ 50 compared to the total number of partners

  4. Overall time being satisfied with treatment since implantation [ Time Frame: up to 10 years post surgery ]
    The interval from the date of regaining a patient EDITS score of 50 or more until the time of EDITS score of less than 50

  5. International Index of Erectile Function - 5 (IIEF short form/SHIM) questionnaire [ Time Frame: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery ]
    The IIEF-5 score is the sum of the ordinal responses to five items; thus, the score can range from 0 to 25. Erectile Dysfunction (ED) severity can be classified into the following five categories based on IIEF-5 scores; severe (0-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22- 25). Mean IIEF-5 scores will be calculated at the indicated time points and numbers / percentages of patients in the different ED severity categories. Also change in IIEF-5 score compared to baseline will be calculated.

  6. Sexual Encounter Profile (SEP) questions 2 and 3 [ Time Frame: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery ]
    For SEP question 2 and 3, scores are percentage of yes responses relative to number of sexual attempts/encounters. Proportions of yes responses will be treated as continuous variables. Post-operative results will also be compared to baseline.

  7. EQ-5D-5L quality of life questionnaire [ Time Frame: at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery ]
    Results of the EQ-5D-5L quality of life questionnaire will be analyzed as described in the EuroQol EQ-5D-5L user guide. Post-operative results will also be compared to baseline.

  8. Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire [ Time Frame: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery ]
    QoLSPP is a 16-item questionnaire, with 4 domains: the functional, relational, social and personal domain. Responses are structured according to a six-point Likert scale, in most cases ranging from "never" (0) to "always" (5), where higher values represent more positive responses. Individual item scores will be analyzed as well as domain scores.

  9. Complications [ Time Frame: during surgery and up to 10 years after surgery ]
    Type of complications, associated symptoms and whether or not a revision was needed will be recorded.

  10. Immediate Postoperative complications [ Time Frame: until 2 weeks after surgery ]
    Type of complications, associated symptoms and whether or not a revision was needed will be recorded and classified according to the Clavien Dindo grading system.

  11. Time of first activation, first cycling, first use, first intercourse, first orgasm, if applicable [ Time Frame: up to 10 years post surgery ]
    The date of first cycling (inflating and deflating the prosthesis several times), the date of first activation and first use for sexual activity, the date of first sexual intercourse and the date of first orgasm, if applicable, will be reported.

  12. Time being revision-free [ Time Frame: up to 10 years post surgery ]
    The interval from the date of surgery to the date of revision whereby revision is defined as any urogenital surgical intervention that is related to the function, placement, or site reaction to the implanted device

  13. Revision-free rate [ Time Frame: at 1, 2, 4, 6, 8 and 10 years of Registry follow-up ]
    The number of patients who are revision-free compared to the total number of patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male patients undergoing a surgical Penile Prosthesis Implant for treatment of erectile dysfunction.
Criteria

Inclusion Criteria:

  • Male patient undergoing a surgical penile prosthesis implant for treatment of erectile dysfunction.
  • Participant is willing and able to give informed consent for participation in the Registry and is able to complete the questionnaires.

Exclusion Criteria:

  • Participating center is unable to contribute consecutive patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849586


Contacts
Layout table for location contacts
Contact: Christien Caris, MSc +31263890677 c.caris@uroweb.org
Contact: Wim Witjes, MD, PhD +31263890677 w.witjes@uroweb.org

Locations
Layout table for location information
Belgium
Jessa Hospital Not yet recruiting
Hasselt, Belgium
Contact: Koenraad van Renterghem, MD, PhD         
Germany
University Hospital Schleswig Holstein Not yet recruiting
Kiel, Germany
Contact: Daniar Osmonov, MD         
Italy
San Raffaele Hospital Not yet recruiting
Milan, Italy
Contact: Federico Deho, MD         
Sub-Investigator: Paolo Capogrosso, MD         
Sponsors and Collaborators
European Association of Urology Research Foundation
Boston Scientific Corporation
Investigators
Layout table for investigator information
Principal Investigator: Koen van Renterghem, MD, PhD Jessa Hospital, Hasselt, Belgium
Principal Investigator: Federico Deho, MD San Raffaele Hospital, Milan, Italy

Additional Information:
Layout table for additonal information
Responsible Party: European Association of Urology Research Foundation
ClinicalTrials.gov Identifier: NCT03849586     History of Changes
Other Study ID Numbers: EAU-RF 2018-01
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Investigators may share anonymized individual data with residents/urologist interested to analyze and publish the results of the registry

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by European Association of Urology Research Foundation:
penile prosthesis implant

Additional relevant MeSH terms:
Layout table for MeSH terms
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders