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

Overview

About this study

Evaluate the efficacy of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy. This study will evaluate men undergoing prostatectomy with bilateral nerve preservation and preserved baseline erectile function (moderate ED or better). The primary outcome will be changes in the IIEF-EFD scores between groups at 6 months. Secondary outcomes include differences in questionnaire outcomes at 3, 6, and 9 months.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/31/2025. Questions regarding updates should be directed to the study team contact.
 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Nahid Punjani, M.D., M.P.H.

Contact us for the latest status

Contact information:

Breanna Russell

(480) 342-2906

Russell.Breanna@mayo.edu

More information

Publications

Publications are currently not available