Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

450

participants targeted

Target at P75+ for all trials

Timeline

67mo left

Started Aug 2021

Longer than P75 for all trials

Geographic Reach

3 countries

25 active sites

Status

enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.3 years study duration

Study Progress47%

Aug 2021Dec 2031

First Submitted

Initial submission to the registry

December 11, 2019

Completed

5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed

1.6 years until next milestone

Study Start

First participant enrolled

August 5, 2021

Completed

9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

9.4 years

First QC Date

December 11, 2019

Last Update Submit

June 11, 2026

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

Change in depressive symptoms and overall sexual function at Post-Surgery, 6 months, 12 months and annually thereafter post device implantation compared to baseline, as measured by the PHQ-9 Depression Questionnaire and the IIEF: Total Score.
Post-Surgery, 6 months, 12 months and annually thereafter through study completion, an average of 10 years
Change in quality of life at 6 months, 12 months, and 24 months post device implantation compared to baseline as measured by the WPAI:GH Questionnaire.
6 months, 12 months and 24 months
Change in erectile function at post-surgery, 12 months and annually post device implantation compared to baseline, as measured by the International Index of Erectile Function Domain (IIEF).
Post-Surgery, 12 months and annually thereafter through study completion, an average of 10 years

Other Outcomes (2)

Device satisfaction at post-surgery, 6 months, 12 months and annually thereafter measured by the Likert scale.
Post-surgery, 6 months, 12 months and annually thereafter through study completion, an average of 10 years
Assess for outcomes and adverse events on AMS Tools at Post Procedure.
Collected only at Post-Procedure

Study Arms (1)

BSC Penile Prothesis Recipients

Men for whom BSC Penile Prothesis is recommended.

Device: Tactra MalleableDevice: Spectra™ Concealable Penile ProthesisDevice: AMS Ambicor™ Inflatable Penile ProsthesisDevice: AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) PumpDevice: AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump

Interventions

Tactra MalleableDEVICE

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.