Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy

Launched by CHARITABLE UNION FOR THE RESEARCH AND EDUCATION OF PEYRONIE'S DISEASE · Feb 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how effective the RestoreX penile traction device is in helping men maintain their ability to get erections after having surgery for prostate cancer, known as a prostatectomy. The trial focuses on men who are having a specific type of surgery called bilateral nerve-sparing prostatectomy, which aims to preserve the nerves that help with erections. To participate, men must be over 18 years old and have a regular sexual partner for at least six months. However, those with severe erectile dysfunction before the surgery or needing certain additional treatments right after surgery cannot join.

Participants in the study will use the RestoreX device and will be asked to complete questionnaires about their erectile function at different times—specifically at 3, 6, and 9 months after starting the trial. The main goal is to see how their erectile function changes over time compared to those who do not use the device. This trial is currently looking for volunteers, and it aims to provide valuable information about ways to help men maintain their sexual health after prostate cancer surgery.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Undergoing bilateral nerve-sparing prostatectomy
• • \>18 years old
• • Have a regular sexual partner for at least 6 months prior to study enrollment
• Exclusion Criteria:
• • Requiring adjuvant radiation therapy or androgen deprivation / androgen blockade post-operatively (by the time of enrollment)
• • Baseline severe erectile dysfunction as measured by the IIEF-EFD
• • Urethral complications from prostatectomy at the time of baseline visit including contrast extravasation, anastomotic dehiscence of vesicourethral anastomosis, need for re-doing of vesicourethral anastomosis intra-operatively