RestoreX™ for penis enlargement

In addition to treating Peyronie's disease, RestoreX™ also helps to lengthen the penis.

RestoreX™ was evaluated in patients who underwent radical prostatectomy resulting in penile shortening: on average, these patients regained 1.6 cm of penile length after 6 months of treatment.

In this randomized clinical study, an improvement in erectile function was also noted with RestoreX™.

Efficacy of a novel penile traction device in improving penile length and erectile function after prostatectomy: Results of a prospective randomized study conducted in a single center.

Amir Toussi, Matthew Ziegelmann, David Yang, Madeleine Manka, Igor Frank, Stephen A Boorjian, Matthew
Tollefson, Tobias Köhler, Landon Trost

Summary of the study

OBJECTIVE

RestoreX™ is a novel penile traction therapy device, with randomized, controlled data demonstrating improvements in penile length and erectile function after 30 to 90 minutes of daily use in men with Peyronie's disease.

We sought to determine whether similar improvements could be achieved after prostatectomy.

MATERIALS AND METHODS

Men following 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.

This 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 to 25 controls and 30 controls treated with penile traction therapy.

At 6 months, penile traction therapy achieved:

• better improvements/preservations of penile length (+1.6 vs. +0.3 cm, p < 0.01)
• of erectile function (IIEF-Erectile Function +0 vs. -6.5, p=0.03)
• of 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 controls in the control group.

Adverse events were transient and mild; 87% would choose to repeat the therapy, and 93% would recommend it to others.

CONCLUSION

Use of a novel penile traction therapy device results in significant improvements in penile length, both objectively and subjectively, after prostatectomy, as well as measures of erectile function, sexual satisfaction with intercourse, and overall sexual satisfaction.

External validation is warranted.

Efficacy of RestoreX™ post-prostatectomy: 1st open-access phase of a randomized clinical study with control group.

Andrew Zganjar, Amir Toussi, Matthew Ziegelmann, Igor Frank, Stephen A Boorjian, Matthew Tollefson, Tobias
Kohler, Landon Trost

Summary of the study

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 postprostatectomy men treated with RestoreX™ penile traction therapy (RxPTT).

MATERIALS AND METHODS

A randomized controlled study (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 treatment data applied: 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 test groups were similar.

Comparing Group 1 and Group 4, notable differences included:

• IIEF Erectile Function (EF) score (-8 vs. -0.5; P = 0.16)
• Penile length (-0.1 vs. +1.7 cm; P < 0.01)
• Use of intracavernous injections (86% vs. 14%; P < 0.01)
  

The Sexual Encounter Profile (SEP) Questionnaire:

• Question 2 (50% vs. 100%; P < 0.01)
• Question 3 (33% vs. 100%; P < 0.01) .

Men who progressed to treatment (Group 2) failed to achieve equivalent improvements in length (+0.5 cm) or sexual function (IIEF-EF score -6) compared with men treated early (Groups 3 and 4).

Those who transitioned 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 improvement in penile length and erectile function, with benefits maintained after therapy is stopped.

If these results are confirmed, they represent the first postoperative therapy demonstrated in a randomized controlled trial to improve erectile function after prostatectomy.

External validation is required.