RESTORE-PC Feasibility Trial

RESTORE-PC Feasibility Trial

Es posible que algunos contenidos no estén disponibles en español.

Purpose of this Study

If you join this study, you will be placed into one of two groups by chance. One group will get pelvic floor physical therapy, which helps with bladder control and sexual function. The other group will get the same therapy plus sex therapy, which includes up to ten video sessions over six months with a trained therapist. These sessions will be audio recorded to make sure the program is being done the right way. Everyone in the study will receive a vacuum erection device and learn how to use it safely. You will fill out surveys about your health and sexual function when you start the study and again at 3, 6, 9, 12, 18, and 24 months. These surveys will ask about sexual function, urinary symptoms, physical health, activity, and mood. You will also take part in short recorded interviews at 6 and 12 months to talk about your experience.

Who Can Participate?

Eligibility

This study is for adult men who were treated for prostate cancer at Duke. Their treatment may have been surgery, radiation, or cryoablation.

Age Range

18-110

Sex/Genders

Male (cisgender)
Looking for Healthy Participants
No

What is Involved?

Description

This study wants to find out if adding sex therapy to regular pelvic floor physical therapy helps people more than pelvic floor physical therapy by itself. Researchers also want to learn if the combined program is easy for people to follow.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery after Prostate Cancer Treatment: A randomized feasibility trial

Principal Investigator

Rebecca
Shelby

Protocol Number

PRO00119667

Enrollment Status

Pending Open to Enrollment