Trimodal Mini-Invasive Therapy for Stable-Phase Peyronie's Disease: A Two-Center Real-Life Prospective Pilot Study

38 men got PRP injections plus two other therapies; curvature dropped 10 degrees, but nobody can say which part worked

Journal: Andrology | Published: 2026-01-14 | Type: Journal Article, Multicenter Study | PMID: 41531263 Authors: Negri Fausto, Pozzi Edoardo, Zahiti Leutrim, Birolini Gabriele, Raffo Massimiliano, d'Arma Alessia, Montorsi Francesco, Mattei Agostino, Salonia Andrea (Vita-Salute San Raffaele University, Milan; Luzerner Kantonsspital, Lucerne) Funding/COI: Not listed

Summary

This pilot study gave 38 men with stable-phase Peyronie's disease two platelet-rich plasma (PRP) injections into their penile plaques, four weeks apart, while simultaneously starting daily tadalafil and vacuum-device stretching. At three months, median penile curvature dropped from 55° to 45°, and Peyronie's disease questionnaire (PDQ) scores improved. Erectile function scores and ultrasound measurements of the plaques didn't change.

Claims

• Median curvature decreased from 55° (IQR 45-70) to 45° (IQR 30-55), a median reduction of 10° (IQR 0-15), p < 0.001
• 2-cycle (double-centrifugation) PRP subgroup: curvature fell from 45° (37-70) to 40° (30-50), p = 0.002
• 1-cycle (single-centrifugation) PRP subgroup: curvature fell from 60° (50-66) to 50° (40-56), p = 0.008
• PDQ scores improved significantly in both subgroups (p ≤ 0.006)
• IIEF-EF scores and dynamic color doppler-duplex ultrasound parameters showed no significant change
• Plaque diameter reduction was not statistically significant
• No treatment-emergent adverse events reported

Study Quality

This is a single-arm, uncontrolled pilot study — there is no comparison group getting tadalafil and vacuum therapy alone, so the curvature reduction cannot be attributed to PRP specifically. All 38 men received the same combination of three interventions (PRP injections, daily tadalafil, and vacuum stretching) at the same time, which means the trial cannot isolate PRP's individual contribution even though PRP is the intervention being studied. The 2-cycle vs. 1-cycle split (22 vs. 16 patients) was not a randomized comparison but appears to reflect a protocol change or site-level practice difference between the two centers, further shrinking each subgroup's statistical power.

The three-month follow-up is short for a condition whose natural history and treatment effects on plaque remodeling are typically assessed over 6-12 months. Wide interquartile ranges at baseline (e.g., 37-70° in the 2-cycle group) indicate a heterogeneous patient population, which makes small median differences harder to interpret. The authors used objective imaging (CDDU) and validated instruments (IIEF, PDQ), which is a methodological plus, but the primary curvature outcome relies on measurement techniques that can vary between examiners and centers.

Red Flags

• No control arm — impossible to separate PRP's effect from tadalafil and vacuum device stretching
• Small sample (n=38) split into two even smaller, non-randomized subgroups (22 and 16)
• Only 3-month follow-up for a condition where treatment effects are usually judged over longer timeframes
• Funding source and conflicts of interest not disclosed
• Primary efficacy signal (curvature) improved, but erectile function and ultrasound plaque measures did not — a mixed result the abstract's framing partly glosses over
• Wide baseline variability (curvature ranges spanning 20-30 degrees) in small subgroups

Strengths

• Prospective design across two centers, rather than retrospective chart review
• Objective imaging endpoint (dynamic color doppler-duplex ultrasound) alongside validated patient-reported outcome measures (IIEF, PDQ)
• Authors explicitly state the curvature reduction is "insufficient to infer clinically meaningful long-term outcomes" — an unusually candid conclusion for a pilot study
• No adverse events reported, supporting a preliminary safety signal for the injection technique

Verdict

A small, uncontrolled pilot study of a three-part combination treatment that can't tell you what PRP itself is doing — worth a skim for the safety data, not for anything about efficacy. The authors' own hedge ("insufficient to infer clinically meaningful long-term outcomes") is more honest than most abstracts in this space, but the missing funding/COI disclosure and lack of a comparator arm mean this is hypothesis-generating at best.