Introduction: Penile length loss and erectile dysfunction (ED) are common post-prostatectomy, with 100% of men experiencing some degree of impairment. Prior publications of RestoreX penile traction therapy (RxPTT) have demonstrated statistically significant improvements in length and erectile function among men with Peyronie’s Disease. The objective of this study is to evaluate the efficacy of PTT in preventing penile length loss and ED in men post-prostatectomy.
Methods: A randomized, controlled trial (NCT03500419) is ongoing to evaluate RxPTT in 70 men post prostatectomy. Men are randomized 1-month post-prostatectomy to no therapy (control) or RxPTT for 30 minutes 5x/week or 60 minutes 7x/week for 5 months. Participants then enter an open label phase for 3 months. Assessments include stretched penile length, standardized (International Index of Erectile Function [IIEF]), and non-standardized questionnaires.
Results: A total of 70 men (mean age 58.4) have been enrolled, with 6-month data available on 36 men (controls=17, RxPTT combined 19). Median baseline penile length (corona) and erectile function domain scores (IIEF-EFD) were 12.5 cm and 27, respectively. After 5 months, results demonstrated significant improvements in penile length among the combined RxPTT group compared to controls (median +2.0 vs 0 cm, p<0.001). RxPTT men also had preserved erectile function, with smaller reductions in IIEF-EFD (median -1 vs -8, p=0.04) and intercourse satisfaction (+0 vs -3.5, p=0.01) compared to controls. RxPTT men had non-statistically significant, higher rates of answering “yes” to sexual encounter profile questions 2 (penetration) and 3 (rigidity) compared to controls (72 vs 54%, p=0.29 and 65 vs 58%, p=0.73, respectively). Mean satisfaction with RxPTT was 8.1/10, while 84% found it meaningful, 90% would recommend it to a friend, and 80% would use RxPTT again if they could start anew.
Conclusions: Based on a limited series, use of RxPTT results in significant improvements in penile length and preserves erectile function and intercourse satisfaction post-prostatectomy compared to controls. If validated with external series, these findings would represent a significant advancement in the prevention of sexual dysfunction post-prostatectomy. Source of
Funding: PathRight Medical provided device to patients free of charge & Internal funding from Mayo Clinic