What are the long‑term durability outcomes (≥2 years) of penile traction therapy in Peyronie’s disease?
Executive summary
Penile traction therapy (PTT) for Peyronie’s disease produces reproducible short‑term gains in stretched/erect penile length and modest reductions in curvature, but high‑quality evidence on whether those gains persist at two years or longer is limited and heterogenous. Randomized data largely cover 3‑month endpoints with open‑label follow‑up and narrative/systematic reviews calling explicitly for longer durable follow‑up and standardized protocols [1] [2] [3].
1. What the trials actually measured and for how long
The strongest controlled evidence comes from a single randomized, single‑blind trial of the RestoreX device that was powered and conducted for a 3‑month primary endpoint (safety, length, curvature, questionnaires) with subjects randomized 3:1 to device versus no therapy, and with subsequent open‑label and follow‑up phases reported separately [1] [2] [4]. Early single‑center pilot and prospective cohorts used treatment windows of months (commonly 3–6 months or protocols of daily hours over 6 months) rather than multi‑year continuous use, so most primary data quantify short‑term anatomic and patient‑reported improvements rather than sustained outcomes beyond the first year [5] [6].
2. Short‑term efficacy that underpins durability claims
Across device types and study designs, PTT has demonstrated consistent short‑term benefits: increased stretched penile length of roughly 1–2+ cm in many cohorts and curvature improvements in the double‑digit percentage range (for RestoreX an as‑treated subgroup with ≥15 minutes/day showed 2.0–2.3 cm length gains and 18–21% curve improvement) — findings reported in the randomized trial and its open‑label follow‑up [7] [2] [4]. Meta‑analyses and narrative reviews corroborate that PTT can be safe, tolerated, and associated with improvements in length and curvature in the stable phase of disease [8] [3] [9].
3. The evidence gap at ≥2 years: what’s missing and why it matters
Despite encouraging short‑term data, reviewers repeatedly flag a lack of standardized, multicenter randomized trials with extended follow‑up measuring the same endpoints at two years or beyond, and call for incorporation of psychosocial outcomes and adherence metrics into long‑term assessments [3] [10]. The randomized RestoreX trial’s primary controlled window was 3 months, and while open‑label follow‑up phases exist, available literature and systematic reviews emphasize heterogeneity in protocols, small cohorts, and inconsistent long‑term reporting — limitations that prevent definitive statements about durability at ≥2 years [1] [7] [8].
4. Signals of durability — cautious optimism, not proof
Some open‑label follow‑up reports and contemporary cohort studies suggest that gains may persist for months to a year and that patients remain satisfied, but these data are uncontrolled or selective and therefore susceptible to selection and adherence biases; systematic reviews therefore treat such signals as promising but preliminary [7] [3] [11]. Practitioner handouts and device manufacturer materials trumpet longer improvements and higher percentages of “straightness” or length recovery, but those sources may not reflect blinded, long‑term clinical trial evidence and should be interpreted alongside peer‑reviewed analyses [12].
5. Practical implications and the research agenda
Clinically, PTT is a reasonable conservative option for men with stable Peyronie’s disease seeking non‑surgical improvement in length and curvature given short‑term safety and efficacy data, but patients and clinicians must recognize the uncertainty about true long‑term durability beyond two years; high‑quality RCTs with standardized adherence measurement and prespecified ≥2‑year endpoints are explicitly needed to resolve that uncertainty [3] [10] [8]. Until then, conclusions about sustained durability at ≥2 years remain provisional and driven by small, heterogeneous follow‑up datasets rather than consistent randomized long‑term evidence [1] [7].