Efficacy of RestoreX after prostatectomy: open‐label phase of a randomized controlled trial

Abstract

To report open-label phase data from a recent randomized controlled trial (RCT), after previous data from that study showed improved penile length and erectile function among post-prostatectomy men treated with Restorex penile traction therapy (RxPTT). Materials and MethodsAn RCT (NCT05244486) was performed to evaluate RxPTT vs no treatment (Tx) for 5 months, which was followed by a 3-month open-label phase. Men were stratified based on as-treated data: Group 1 = No Tx; Group 2 = No Tx ? Tx; Group 3 = Tx ? No Tx; Group 4 = Tx. Assessments included stretched penile length and standardized (International Index of Erectile Function [IIEF]) and non-standardized questionnaires. ResultsA total of 82 men were enrolled (mean age 58.6 years) with 9-month data available in 45 of the men. Baseline characteristics were similar among the cohorts. Comparing Group 1 and Group 4 (respectively), notable differences included: IIEF Erectile Function domain (IIEF-EF) score (À8 vs À0.5; P = 0.16), penile length (À0.1 vs +1.7 cm; P < 0.01), intracavernosal injection use (86% vs 14%; P < 0.01), Sexual Encounter Profile (SEP) Question 2 (50% vs 100%; P < 0.01), SEP Question 3 (33% vs 100%; P < 0.01). Men who crossed over to Tx (Group 2) failed to achieve equivalent improvements in length (+0.5 cm) or sexual function (IIEF-EF score À6) compared to men treated early (Groups 3 and 4). Those who crossed over to no treatment after initial treatment (Group 3) experienced preserved length (+1.8 cm), and erectile function (IIEF-EF score +0) despite therapy discontinuation. ConclusionsUse of RxPTT beginning 1 month post-prostatectomy results in improved penile length and erectile function, with benefits maintained after discontinuing therapy. If confirmed, these results represent the first postoperative therapy shown in a RCT to improve erectile function post-prostatectomy. External validation is warranted.

Reviving intimacy: Penile rehabilitation strategies for men after prostate cancer treatment

“…The RxPTT has several improved characteristics including a modified penile clamp, counterbending, stronger mechanical springs, and dynamic adjustment of traction during us. 44 , 45 Overall, there were no significant adverse events, and men who used RxPTT were satisfied with the treatment and would recommend it to a friend. 44 …”

Efficacy of RestoreX after prostatectomy: open‐label phase of a randomised controlled trial

“…The role of PTT in PD relies on the cellular mechanotransduction effect with alterations in the connective tissue structures and collagen remodelling, as evidenced by the increase in matrix metalloproteinases [5]. The lack of effect of RxPTT beyond 6 months as reported by this paper [3] is certainly intriguing. While the authors postulated that there was a limited therapeutic window to preserve erectile function after prostatectomy and progressive cavernosal fibrosis to explain the observed difference in clinical outcomes in delayed treatment (Group 2) compared to earlier treatment (Group 1), it is a known fact that PTT is used extensively to improve the penile length and cosmesis in males with short penis and/or penile dysmorphophobia [6,7].…”

“…This open‐label, randomised, controlled trial on the RestoreX device (PathRight Medical Inc., Plymouth, MN, USA) [3] provides an important addition to the literature on PTT use in the post‐prostatectomy cohort, where the loss of penile length is often attributed to corporal fibrosis due to underlying erectile dysfunction (ED). The RestoreX device is advertised as a second‐generation penile traction device as it can allow for greater application of traction forces, including a modified penile clamping mechanism that displaces the traction force more broadly to the head of the penis, while at the same time, provides a counter‐bending force on a wider displacement base, resulting in a more dynamic adjustment of traction during device use.…”

“…While published literature on PTT is often hampered by lack of treatment randomisation, small numbers of participants, and poor treatment compliance, the potential benefits of this relatively benign therapy, which can assist in preserving and/or lengthening the penis while improving penile curvature, is often favoured by patients who do not wish to undergo definitive but invasive penile reconstructive surgery [2]. This open-label, randomised, controlled trial on the RestoreX device (PathRight Medical Inc., Plymouth, MN, USA) [3] provides an important addition to the literature on PTT use in the post-prostatectomy cohort, where the loss of penile length is often attributed to corporal fibrosis due to underlying erectile dysfunction (ED). The RestoreX device is advertised as a second-generation penile traction device as it can allow for greater application of traction forces, including a modified penile clamping mechanism that displaces the traction force more broadly to the head of the penis, while at the same time, provides a counter-bending force on a wider displacement base, resulting in a more dynamic adjustment of traction during device use.…”

Thoughts on ‘Efficacy of RestoreX after prostatectomy: open‐label phase of an RCT’

“…We congratulate Zganjar et al on their evaluation of the effects of RestoreX penile traction therapy following post‐prostatectomy. 1 This single‐centre, randomised trial offers valuable insights into the impact of RestoreX on a common yet under‐researched complication: reduced penile length. Given that prostate cancer is the most common cancer worldwide, 2 and prostatectomy remains the definitive treatment of choice, this study addresses some important concerns related to post‐prostatectomy complications and potential management strategies.…”