Clinical Trials

Study Title

Malleable Treatment – the Tactra Erectile Restoration Study

Purpose

The primary objective of the It MATTERS study is to assess erectile function at 6 months, post implantation of the Tactra™ Malleable Penile Prosthesis, demonstrating an improvement in quality of life from baseline

Eligibility

Adult males with moderate to severe erectile dysfunction (IIEF-EF domain (questions 1-5 and 15) score of 1-16)

Willing and able to undergo surgical implantation of the Tactra device

Willing and able to complete the informed consent process

Willing and able to comply with the follow-up requirements Negative urine culture

Cannot:

Subjects with a prior history of penile prosthesis surgery

Subjects with a prior history of corporal dilation

Subjects with a prior history of Peyronie’s disease

Subjects with a prior history of priapism

Subjects with a prostate condition that is expected to require surgical intervention during the course of the study

Subjects receiving any other surgical erectile dysfunction treatment(s) while participating in the study (else subject voluntarily exits study)

Subjects receiving other medical treatment for erectile dysfunction while participating in the study (else subject voluntarily exits study)

Subjects receiving any other surgical treatment at the time of the Tactra implantation.

Subjects whose total intracorporal length is not within the range of 14 cm to 27 cm.

Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor

Subjects with need for intermittent catheterization

Study Process

It MATTERS will be a single-arm, non-randomized, prospective, multi-center study with follow-up occurring at 1 month, 3 months, 6 months, 12 months, and annually thereafter for up to 5 years. Subjects will serve as their own control as follow-up assessments will be compared to values obtained at baseline.