RestoreX: Penile Traction Therapy in Men with Peyronie's Disease
RestoreX was a single-center, single-blind randomized trial in 110 men with Peyronie's disease and curvature of 30 degrees or more that compared the RestoreX penile traction device, worn for 30 to 90 minutes daily, with no therapy for 3 months. The primary outcome was safety, which the authors judged met: all adverse events were mild and transient. At 3 months penile length increased by 1.5 cm with traction versus 0 cm with no therapy, and composite curvature changed by −11.7 versus +1.3 degrees.[1]
- Design and population
- Single-center, single-blind (investigator) randomized controlled intent-to-treat trial; no therapy versus traction allocated 1:3. 110 men with Peyronie's disease (diagnosed within 10 years) and curvature of 30 degrees or more, enrolled without exclusion for complex curvature, hourglass deformity, prior Peyronie's treatment or surgery, or calcification.
- Arms
- RestoreX penile traction therapy for 30 to 90 minutes daily versus no therapy
- Report and follow-up
- 2019 · 3 months of randomized treatment
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| Adverse events through 3 months in men treated with traction | No moderate or severe adverse events | — | Met |
| Mean (SD) change at 3 months, pubic symphysis to penile tip | +1.5 cm (SD 1.1) vs 0.0 cm (SD 0.7) | difference 1.5; P <0.001 | Met |
| Mean (SD) change at 3 months, pubic symphysis to glanular corona | +1.3 cm (SD 1.1) vs +0.3 cm (SD 0.8) | difference 1; P <0.001 | Met |
| Mean (SD) change at 3 months, composite curvature | −11.7 degrees (SD 15.0) vs +1.3 degrees (SD 19.0) | difference -13; P <0.01 | Met |
| Mean (SD) change at 3 months, primary (larger) curvature | −8.5 degrees (SD 10.1) vs −1.1 degrees (SD 7.5) | difference -7.4; P <0.001 | Met |
| Mean (SD) change in IIEF erectile function domain at 3 months, men with baseline erectile dysfunction (domain score 25 or less) | +4.3 (SD 7.4) vs −0.7 (SD 6.1) | difference 5; P 0.01 | Met |
| Mean (SD) change in IIEF erectile function domain at 3 months, all men | +2.5 (SD 6.3) vs −1.3 (SD 6.7) | difference 3.8; P 0.06 | Not met |
| Traction-treated men with improved curvature at 3 months | 77% | — | Descriptive |
| Traction-treated men with increased length at 3 months | 94% | — | Descriptive |
| Preference for RestoreX among men who had used another traction device | 100% | — | Descriptive |
| Men who would choose RestoreX as first treatment if starting Peyronie's therapy anew | 74.1% | — | Descriptive |
| Overall satisfaction with traction at 3 months | 25.4% very satisfied, 41.3% somewhat satisfied | — | Descriptive |
Harms: Moderate or severe adverse events: 0 (62 men assessed at 3 months); Penile erythema or discoloration: 45.2% at 3 months versus 8.6% at baseline; New mild penile pain: 53.2%
Design
Men were recruited from the Mayo Clinic Andrology Clinic by mailed invitation (800 mailed, 110 randomized) if Peyronie's disease had been diagnosed within 10 years; enrollment ran from October 2017 through August 2018. Inclusion required age over 18 years and curvature of 30 degrees or more, and exclusions were a stretched penile length under 7 cm and severe diabetes with end-organ failure. Complex curvature, hourglass deformity, indentation, prior Peyronie's therapy or surgery and known calcification were not exclusions, and men on other therapy stopped it at least 1 month before enrollment.[1] The registry record also lists erectile dysfunction unresponsive to phosphodiesterase-5 inhibitors or intracavernosal injection as an exclusion.[2]
The cohort was difficult to treat. Mean age was 58.4 years, mean disease duration 49.7 months and mean curvature 59.3 degrees; 60.0% had multiplanar curvature, 40.0% indentation, 39.9% hourglass deformity and 67.9% prior Peyronie's therapy (collagenase in 33.6%, traction in 20%, surgery in 3.6%), and 97% were beyond the first 3 months of disease.[1] The arms were similar at baseline, although calcification was 8.7% with traction versus 33.3% with no therapy (P = 0.10).[1]
Allocation was 1:3 to no therapy (28 men) or traction (82 men). The traction group was three dose groups of 27, 28 and 27 men using the device for 30 minutes (15 straight, 15 with counter-bending) once, twice or three times daily, and the efficacy analyses pooled them. Randomization tables were created in advance by primary curvature direction and baseline curvature (30 to 60 versus more than 60 degrees), and men kept a daily diary of traction duration and counter-bending.[1]
The primary outcome was safety, with no numeric threshold stated; the secondary outcomes were curvature, length, IIEF and Peyronie's Disease Questionnaire (PDQ) scores, satisfaction and the need for further therapy.[1] Length was the mean of two independent providers blinded to group, measured from the pubic symphysis to the corona and to the tip. Curvature was measured on photographs taken after intracavernous Trimix and reviewed by one blinded individual; the larger angle was the primary curvature and the sum of all curvatures the composite.[1] The analysis was by intent to treat with no men excluded for noncompliance, and dose subgroups were analyzed by actual use. With 20 men per arm the trial could detect a length difference of 0.6 cm (SD 1.0) and a curvature difference of 10 degrees (SD 15) (alpha 0.05 and beta 0.8, as printed), and it was not powered for IIEF, PDQ or dose-group comparisons.[1]
Results
Safety was the primary outcome and was met (see Adverse events). Three-month length and curvature data were available for 62 traction men and 27 controls. Mean length to the penile tip increased by 1.5 cm (SD 1.1) with traction and 0.0 cm (SD 0.7) with no therapy, and length to the corona by 1.3 cm (SD 1.1) versus 0.3 cm (SD 0.8), both P < 0.001. Composite curvature changed by −11.7 degrees (SD 15.0) versus +1.3 degrees (SD 19.0) (P < 0.01), and primary curvature by −8.5 degrees (SD 10.1) versus −1.1 degrees (SD 7.5) (P < 0.001).[1] A composite response (curvature improvement of at least 20% with a 1-point or greater PDQ bother improvement, or a return to sexual activity) occurred in 24.6% versus 4% (P = 0.01).[1]
Among men with baseline erectile dysfunction, IIEF erectile function changed by +4.3 versus −0.7 (P = 0.01), and the improvement remained significant after controlling for curvature change (P < 0.01). Across all men the change was +2.5 versus −1.3 (P = 0.06; 59 and 26 men), the overall-satisfaction domain changed by +0.6 versus −0.4 (P = 0.03), and 4 of 8 traction men versus 0 of 4 controls who could not penetrate at baseline could at 3 months (P = 0.03). PDQ changes were not significant: −2.3 versus −0.6 for the psychological and physical domain (P = 0.09), −2.4 versus −0.9 for bother (P = 0.07) and −1.4 versus −0.8 for pain (P = 0.26).[1]
Among traction-treated men, curvature improved in 77% (27% by at least 20 degrees) and length increased in 94% (29% by at least 2 cm); the denominators are not stated.[1] Of 15 men who had used another traction device, all preferred RestoreX (87% much better), and 74% of 54 respondents would choose it first if starting therapy again. Satisfaction was 25.4% very and 41.3% somewhat satisfied.[1]
The dose-group comparison was underpowered, and the once-, twice- and three-times-daily groups did not differ significantly in length or curvature. In a post hoc analysis, men with at least 5,000, 6,000 and 7,000 total traction minutes (56, 67 and 78 minutes daily) gained 1.6, 2.1 and 2.3 cm, a nonsignificant trend.[1]
After the 3-month visit, men in both groups could use the device on an open-label basis. Outcomes were reported for 64 men at 6 months and 63 at 9 months. By intent to treat during the 3-to-6-month open-label phase, men who moved from control to traction gained 1.7 to 2.0 cm in length and improved curvature by 18% to 20%, and men who continued traction gained a further 0.6 to 0.8 cm without further curvature improvement.[3] In the as-treated analysis of 51 men who used traction at least 15 minutes per day during months 3 to 6, stretched length to the corona increased 2.0 to 2.3 cm from baseline to month 6 and composite curvature improved by 18% to 21%.[3] Among 37 men originally assigned traction who used RestoreX at least 15 minutes daily during the final 3 months, 95% gained length and 61% improved curvature at 6 months; responders gained a mean 2.0 cm to the corona or 2.2 cm to the tip and improved a mean 16.8 degrees in primary or 21.4 degrees in composite curvature.[3] In the as-treated analysis of men using the device at least 15 minutes daily during months 3 to 6, the 6-month length change to the corona was +2.0 cm in 37 original traction men and +2.3 cm in 14 original controls (P = 0.90), and composite curvature changed by −14.9 versus −12.5 degrees (P = 0.64).[3]
Surgery and treatment delivery
Men wore the device for 30 minutes (15 straight, 15 with counter-bending) once, twice or three times daily for 3 months. Actual use averaged 43 minutes per day (range 16 to 84), and compliance was 100%, 82% and 47% in the once-, twice- and three-times-daily groups.[1] The protocol defined technique by two features, a straight stretch that buries the white indicator line and counter-bending to about 90 degrees, and called men non-compliant if they missed either on most uses or did traction on fewer than 90% of recommended days.[2] The white line indicates more than 3 pounds of force when concealed. In early analyses of the device features, counter-bending to 60 to 120 degrees improved curvature more than bending to 30 degrees (P < 0.01), and men who saw the white line most of the time had no length gain (mean −0.17 cm) and less curvature improvement (−2.1 versus −13.9 degrees, P = 0.02) than men who kept it concealed.[1] Open-label use averaged 31.1 minutes.[3]
Three-month data were available for 90 men: 63 of 82 traction men (77%) and 27 of 28 controls (96%). Nineteen traction men (6, 5 and 8 in the once-, twice- and three-times-daily groups) and 1 control withdrew before 3 months, and the text does not give reasons.[1]
Adverse events
The primary outcome of safety was met. At 3 months (62 men) there were no moderate or severe adverse events, no patient withdrew or reduced treatment because of adverse events, and most events resolved within seconds or minutes of stopping. Penile erythema or discoloration affected 45.2% (8.6% at baseline) and new mild penile pain 53.2%; loss or abnormal sensation was present in 25.8% (29.6% at baseline). New cold glans (3.2%), swelling (3.2%) and a new bump (1.6%) were less common, and other events (8.1%) were minor curvature that resolved by the next session, mild skin erosion from tape that resolved in 2 days, delayed urine stream not thought related to traction, skin sensitivity to the tape and testicular pain that resolved after device discontinuation.[1]
During open-label use, temporary erythema and discomfort were the most common events and resolved within minutes.[3] The registry reported erythema or discoloration in 35%, new mild penile pain in 27% and loss or abnormal sensation in 5% of 63 men at 6 months, with no serious events.[2]
Limitations
The trial was single-center, and the device was developed in cooperation with Mayo Clinic: the paper reports internal Mayo Clinic funds and an anonymous patient gift, devices donated by PathRight Medical and a financial interest of the corresponding author in PathRight, and the protocol names the principal investigator as the device's inventor.[1][2] The comparator was no therapy, and blinding was of the investigator, so IIEF, PDQ and satisfaction responses came from men who knew whether they used the device.[1] Three-month data were available for 63 of 82 traction men and 27 of 28 controls, although the analysis is described as intent to treat.[1] The authors list sample size and the absence of a 3-to-8-hour daily arm as limitations; they regard the missing arm as intentional because such use is unrealistic for most men.[1] Control men could begin open-label traction after 3 months, so the 6- and 9-month outcomes have no control group, and no arm tested the longer daily durations used by other devices.[3] Safety was the primary outcome; the length and curvature results come from secondary outcomes, and the dose-duration and device-feature analyses were early or post hoc.[1]
In conversation
Same setting IMPRESS (2013)
The EAU guideline describes traction devices as used two to eight hours daily; this trial tested a device worn for 30 to 90 minutes.[4] The authors contrast it with a Spanish randomized trial of the Penimaster PRO worn 6 to 8 hours daily in 93 men with chronic disease; they note that trial excluded men with curvature under 45 degrees, multiplanar curvature, prior intralesional therapy, hourglass deformity or noncompliance with traction of 3 hours or more daily, criteria that would have excluded 90% of RestoreX participants, and that baseline curvature was 72.3 degrees versus 45.4 (primary curvature) in RestoreX.[1]
Guidelines and approvals
- EAU Sexual and Reproductive Health (limited update March 2026), section 8.2.3.a.4. Offer penile traction devices and vacuum devices to reduce penile deformity or as part of a multimodal therapy approach, although outcome data are limited . The guideline cites this trial among five references when it states that traction evidence is limited by small numbers, heterogeneous designs and non-standardized inclusion criteria, and it concludes that evidence is lacking for a definitive recommendation of traction as monotherapy.[4]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2019-08-08 | Randomized phase (3 months) · primary | — | Adverse events through 3 months in men treated with traction: No moderate or severe adverse events; — Met Mean (SD) change at 3 months, pubic symphysis to penile tip: +1.5 cm (SD 1.1) vs 0.0 cm (SD 0.7); difference 1.5; P <0.001 Met Mean (SD) change at 3 months, pubic symphysis to glanular corona: +1.3 cm (SD 1.1) vs +0.3 cm (SD 0.8); difference 1; P <0.001 Met Mean (SD) change at 3 months, composite curvature: −11.7 degrees (SD 15.0) vs +1.3 degrees (SD 19.0); difference -13; P <0.01 Met Mean (SD) change at 3 months, primary (larger) curvature: −8.5 degrees (SD 10.1) vs −1.1 degrees (SD 7.5); difference -7.4; P <0.001 Met Men with at least 20% curvature improvement plus at least 1-point PDQ bother improvement, or a change from no sexual activity to sexual activity: 24.6% vs 4%; P 0.01 Mean (SD) change in IIEF erectile function domain at 3 months, men with baseline erectile dysfunction (domain score 25 or less): +4.3 (SD 7.4) vs −0.7 (SD 6.1); difference 5; P 0.01 Met Mean (SD) change in IIEF erectile function domain at 3 months, all men: +2.5 (SD 6.3) vs −1.3 (SD 6.7); difference 3.8; P 0.06 Not met Mean (SD) change in IIEF intercourse satisfaction domain at 3 months: +1.5 (SD 2.9) vs −0.4 (SD 4.6); difference 1.9; P 0.08 Mean (SD) change in IIEF overall satisfaction domain at 3 months: +0.6 (SD 1.8) vs −0.4 (SD 2.2); difference 1; P 0.03 Men unable to penetrate at baseline (Sexual Encounter Profile question 2) who could at 3 months: 4/8 (50%) vs 0/4 (0%); P 0.03 Mean (SD) change in psychological and physical domain at 3 months: −2.3 (SD 4.1) vs −0.6 (SD 3.3); difference -1.7; P 0.09 Mean (SD) change in symptom bother domain at 3 months: −2.4 (SD 3.4) vs −0.9 (SD 4.2); difference -1.5; P 0.07 Mean (SD) change in penile pain domain at 3 months: −1.4 (SD 3.2) vs −0.8 (SD 3.6); difference -0.6; P 0.26 Men for whom vaginal intercourse was difficult or impossible at baseline (question 12) and no longer was at 3 months: 47.6% vs 18.2%; P 0.09 Traction-treated men with improved curvature at 3 months: 77%; — Descriptive Traction-treated men with increased length at 3 months: 94%; — Descriptive Length and curvature among men reclassified by actual use of once, twice or three times daily: No significant difference between groups; — Mean (SD not given) length gain by total traction minutes over 3 months: 1.6, 2.1 and 2.3 cm; — Preference for RestoreX among men who had used another traction device: 100%; — Descriptive Men who would choose RestoreX as first treatment if starting Peyronie's therapy anew: 74.1%; — Descriptive Overall satisfaction with traction at 3 months: 25.4% very satisfied, 41.3% somewhat satisfied; — Descriptive | Ziegelmann M, Savage J, Toussi A, et al. Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial. *J Urol.* 2019;202(3):599-610. DOI |
| 2020-11-20 | Open-label and follow-up phases (6 and 9 months) · updated | — | Gain in men crossed from control to traction (intent to treat), months 3 to 6: +1.7 to +2.0 cm; — Improvement in men crossed from control to traction (intent to treat), months 3 to 6: 18% to 20%; — Additional gain from months 3 to 6 in men continuing traction from the randomized phase: +0.6 to +0.8 cm; — Gain in length to the glanular corona from baseline to 6 months with traction of at least 15 minutes per day during months 3 to 6 (as-treated; range across the original traction and original control groups): +2.0 to +2.3 cm; — Improvement in composite curvature from baseline to 6 months with traction of at least 15 minutes per day during months 3 to 6 (as-treated; range across the original traction and original control groups): 18% to 21%; — Men in the original traction arm analyzed as treated (n=37) with length gain at 6 months: 95%; — Descriptive Men in the original traction arm analyzed as treated (n=37) with curvature improvement at 6 months: 61%; — Descriptive Change at 6 months to glanular corona, original control versus original traction group, as-treated (men using the device at least 15 minutes per day during months 3 to 6): +2.0 cm vs +2.3 cm; difference -0.3; P 0.90 Change at 6 months, original control versus original traction group: −14.9 degrees vs −12.5 degrees; difference -2.4; P 0.64 | Joseph J, Ziegelmann M, Alom M, et al. Outcomes of RestoreX Penile Traction Therapy in Men with Peyronie's Disease: Results from Open Label and Follow-Up Phases. *J Sex Med.* 2020;17(12):2462-2471. DOI |
References
1. Ziegelmann M, Savage J, Toussi A, et al. "Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial." J Urol. 2019;202(3):599-610. doi:10.1097/JU.0000000000000245
2. Mayo Clinic. "Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized Trial." ClinicalTrials.gov identifier NCT03389854; results and study protocol (April 9, 2018). Registry record
3. Joseph J, Ziegelmann M, Alom M, et al. "Outcomes of RestoreX Penile Traction Therapy in Men with Peyronie's Disease: Results from Open Label and Follow-Up Phases." J Sex Med. 2020;17(12):2462-2471. doi:10.1016/j.jsxm.2020.10.003
4. European Association of Urology. EAU Guidelines on Sexual and Reproductive Health. Limited update March 2026. Sections 8.2.3.a.3 (other treatments, including penile traction therapy) and 8.2.3.a.4 (summary of evidence and recommendations for conservative treatment of Peyronie’s disease).