RestoreX™ has been evaluated in patients who have undergone radical prostatectomy causing penile shortening : on average, these patients recovered 1.6 cm of penis length after 6 months' treatment.
In these randomized clinical studies, an improvement in erectile function was also noted.
The RestoreX™ has not been studied to increase penis length and we refrain from communicating information when it has not been validated by prospective, randomized clinical studies. We do know that RestoreX enables lengthening of small yards (between 1 and 2 cm) and that this works when used regularly over a period of more than 3 months, but we cannot affirm or prove it.
Toussi & al: Efficacy of a Novel Penile Traction Device in Improving Penile Length and Erectile Function PostProstatectomy: Results from a Single-Center Randomized, Controlled Trial/AUA - The Journal of Urology -August 2021, Volume 206, Issue 2, Page: 416-426
Efficacy of a novel penile traction device in improving penile length and erectile function after prostatectomy: Results of a prospective randomized single-center study.
Amir Toussi, Matthew Ziegelmann, David Yang, Madeleine Manka, Igor Frank, Stephen A Boorjian, Matthew
Tollefson , Tobias Köhler , Landon Trost
Study summary
OBJECTIVE
RestoreX™ is a novel penile traction therapy device, with randomized controlled data demonstrating improvements in penile length and erectile function after 30-90 minutes of daily use in men with Lapeyronie's disease.
We sought to determine whether similar improvements could be achieved after prostatectomy.
MATERIALS AND METHODS
Men after prostatectomy were randomized to a control group or one of two penile traction therapy protocols for 6 months, followed by a 3-month open-access phase.
The present study presents data from the randomized phase.
The primary endpoint was changes in penile length in extension; secondary endpoints were changes in International Index of Erectile Function (IIEF) scores, adverse events, satisfaction and subjective measures.
RESULTS
Overall, 82 men (mean age 58.6 years) were randomized with data available at 6 months for 25 control group controls and a further 30 controls treated with penile traction therapy.
At 6 months, penile traction therapy resulted in:
- better improvements/preservation of penile length (+1.6 vs. +0.3 cm, p <0.01)
- erectile function (IIEF-Erectile function +0 vs. -6.5, p=0.03)
- sexual satisfaction with intercourse (IIEF-Satisfaction with intercourse +1 vs. -3.5, p <0.01)
- of overall sexual satisfaction (IIEF-Overall sexual satisfaction 0 vs -3, p <0.01).
The use of erectogenic therapies was lower in men treated with penile traction therapy (phosphodiesterase-5 inhibitors 86% vs. 94%, p=0.44; intracavernosal injections 19% vs. 50%, p <0.05).
More men treated with penile traction therapy reported satisfaction or improvement in penile length than control group controls.
Adverse events were transient and mild; 87% would choose to repeat the therapy, and 93% would recommend it to others.
CONCLUSION
The use of a novel penile traction therapy device results in significant improvements in both objective and subjective penile length after prostatectomy, as well as measures of erectile function, intercourse-related sexual satisfaction and overall sexual satisfaction.
External validation is warranted.
Zganjar & al: Efficacy of RestoreX™ Post Prostatectomy: Open-label Phase of a Randomized, Controlled Trial
Efficacy of RestoreX™ in post-prostatectomy: 1st open-access phase of a randomized clinical trial with control group.
Andrew Zganjar, Amir Toussi , Matthew Ziegelmann, Igor Frank, Stephen A Boorjian , Matthew Tollefson, Tobias
Köhler , Landon Trost
Study summary
OBJECTIVE
To report data from the open-access phase of a recent randomized controlled trial (RCT), after previous data from this study showed improvements in penile length and erectile function in post-prostatectomy men treated with RestoreX™ penile traction therapy (RxPTT).
MATERIALS AND METHODS
A randomized controlled trial (NCT05244486) was conducted to evaluate the RestoreX™ penile traction system (RxPTT) versus no treatment (NoTx) for 5 months, followed by a 3-month open access phase.
Men were classified according to applied treatment data: Group 1 = NoTx; Group 2 = NoTx → Tx; Group 3 = Tx → NoTx; Group 4 = Tx.
Assessments included penile length in extension as well as the standardized IIEF (International Index of Erectile Function) questionnaire and a non-standardized questionnaire.
RESULTS
A total of 82 men were included in the study (mean age 58.6 years) and follow-up data for 9 months were available for 45 of them.
The characteristics of the trial groups were similar.
Comparing Group 1 and Group 4, notable differences included:
- IIEF Erectile Function (EF) score (-8 vs -0.5; P = 0.16)
- Penis length (-0.1 vs +1.7 cm; P < 0.01)
- The use of intracavernosal injections (86% vs. 14%; P < 0.01)
The Sexual Encounter Profile Questionnaire (SEP) :
- Question 2 (50% vs. 100%; P < 0.01)
- Question 3 (33% vs. 100%; P < 0.01).
Men who switched to treatment (Group 2) failed to achieve equivalent improvements in length (+0.5 cm) or sexual function (IIEF-EF score -6) compared with early-treated men (Groups 3 and 4).
Those who switched to no treatment after initial treatment (Group 3) preserved their length (+1.8 cm) and erectile function (IIEF-EF score +0) despite stopping therapy.
CONCLUSION
Use of RestoreX™ 1 month after prostatectomy results in improved penile length and erectile function, with benefits maintained after discontinuation of therapy.
If confirmed, these results represent the first postoperative therapy demonstrated in a randomized controlled trial to improve erectile function after prostatectomy.
External validation is required.
