What have studies found?
Prospective registries and smaller observational series report that venous leak embolization can improve erectile-function scores in selected men with confirmed venogenic erectile dysfunction, including men who have not responded adequately to PDE5-inhibitor medication. The most informative contemporary cohorts report clinical improvement in approximately six of ten evaluable patients at their defined follow-up visits.
Early improvement
34/50 patients met a prespecified IIEF-15 improvement threshold at six weeks in Diehm et al. (2023).
Midterm improvement
82/138 evaluable patients met the study threshold at approximately nine months in Hoppe et al. (2026).
Technical success versus clinical benefit
| Measure | What it means | Reported example |
|---|---|---|
| Technical success | Targeted veins were embolized as intended | 193/194 procedures (99.5%) in Hoppe 2026 |
| Clinical improvement | Erectile-function score improved by the predefined threshold | 82/138 evaluable patients (59.4%) in Hoppe 2026 |
| Recurrence or persistence | Venous leakage persisted or returned during reported follow-up | 18/175 patients (10.2%) in Hoppe 2026 |
Selected published studies
Hoppe et al., 2026 — Prospective multicenter registry
175 enrolled patients with venogenic ED unresponsive to PDE5 inhibitors. The study reported 99.5% technical success per procedure, clinical improvement in 59.4% of evaluable patients at approximately nine months, and recurrence or persistence of venous leak in 10.2% during reported follow-up. Non-target pulmonary embolism was reported in 3/175 patients (1.7%).
Different denominators apply to enrolled patients, evaluable outcomes, and procedures.Diehm et al., 2023 — Prospective single-center registry
Among 50 consecutive patients, technical success was reported in 49/50 (98%) and 34/50 (68%) met the prespecified erectile-function improvement threshold at six weeks. Follow-up was short and the study had no randomized comparator.
Doppalapudi et al., 2019 — Systematic review and meta-analysis
The venous-occlusive dysfunction subgroup included 212 patients across studies and reported pooled clinical success of 59.8%. Definitions of success and techniques varied substantially, limiting direct comparisons.
Other observational evidence
Older single-center series and studies combining open surgery with embolization provide additional context. Outcomes from combined surgery should not be presented as outcomes of embolization alone.
Safety, durability, and uncertainty
Reported risks can include bleeding, infection, contrast-related reactions, radiation exposure, non-target embolization, and persistent or recurrent erectile dysfunction. Some series report low rates of major adverse events, but serious events are possible. In the 2026 registry, non-target pulmonary embolism occurred in 1.7% of enrolled patients.
Longer-term durability remains less certain. Some patients develop recurrent or persistent venous leakage, potentially due to recanalization or collateral veins. Studies differ in follow-up length, patient selection, procedure details, and definitions of success.
The PIVET-ED sham-controlled trial protocol was published in 2022, but the literature summarized here did not identify published efficacy results. Therefore, current registry outcomes cannot establish how much benefit is attributable specifically to embolization compared with placebo or other care.
References
- Diehm N, et al. Cardiovasc Intervent Radiol. 2023;46:610–616. doi:10.1007/s00270-023-03412-2
- Hoppe H, et al. Cardiovasc Intervent Radiol. 2026;49:556–566. doi:10.1007/s00270-025-04246-w
- Doppalapudi SK, et al. J Vasc Interv Radiol. 2019;30:1251–1258.e2. doi:10.1016/j.jvir.2019.01.024
- Moriarty HK, et al. Cardiovasc Intervent Radiol. 2022;45:155–161. doi:10.1007/s00270-021-03021-x
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