Restorex Penile Traction Therapy in Preserving Erectile Function
Research type
Research Study
Full title
Efficacy of Restorex Penile Traction Therapy in Preserving Erectile Function Post-Prostatectomy
IRAS ID
344690
Contact name
Brian Leaker
Contact email
Sponsor organisation
CURE PD
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This study will investigate how well Restorex preserves erectile function in men after prostatectomy (surgery to remove the prostate).
Erectile dysfunction is a common side effect after prostatectomy, without effective preventative therapies. RestoreX® is a mechanical device that gently stretches the penis (traction therapy). When used regularly, this helps tissue growth and overall health of the penis, and so can help limit the loss of erectile function after prostatectomy surgery.
This is a controlled randomized study, spanning three years. Subject participation is approximately 11 months; a 5-month treatment period, a 3-month open-label phase, and up to 3 months of safety follow-up. Patients will be randomised to receive either standard prostatectomy after-care and RestoreX® traction (therapy group), or standard prostatectomy after-care alone (control group) in a ratio of 2 therapy:1 control.
An estimated 350 patients will be screened to enroll 250 men undergoing prostatectomy with bilateral nerve preservation and moderate or better baseline erectile function. Participants must also be >18 years old, and have a regular sexual partner. The RestoreX® device will be used for 30-60 minutes daily, 5-7 days a week, for five months, followed by a 3-month open-label phase with optional use for both the therapy and control groups. Assessments include questionnaires at baseline and 3, 6, and 9 months post-prostatectomy, and device usage diaries.
The primary objective of the study is to compare erectile function between treatment and control cohorts at 6 months after surgery. This is assessed by the International Index of Erectile Function, Erectile Function Domain (IIEF-EFD) questionnaire. Secondary objectives include comparing IIEF-EFD categories, adverse events and subjective questionnaires related to sexual function at the set time points.
The study will be conducted at a single centre in the UK and other sites in the USA.
REC name
South West - Frenchay Research Ethics Committee
REC reference
24/SW/0106
Date of REC Opinion
17 Sep 2024
REC opinion
Further Information Favourable Opinion