Does a 24-h Closed-Suction Drain Reduce Infection and Hematoma After Inflatable Penile Prosthesis Surgery? A Comparative Study

Drain use after three-piece penile implant surgery showed no benefit — hematoma rates trended slightly higher in the drain group

Journal: The Journal of Sexual Medicine | Published: 2026-05-11 | Type: Retrospective Comparative Study | PMID: 42153744 Authors: Ortaç M et al. (Istanbul University Faculty of Medicine; Altınbas University Bahcelievler Medikal Park Hospital; Haseki Training and Research Hospital — all Istanbul, Turkey) Funding/COI: Not listed for either

Summary

This retrospective study of 410 men undergoing primary three-piece penile prosthesis implantation found that placing a 24-hour closed-suction drain did not reduce postoperative hematoma, infection, or mechanical failure. Counterintuitively, hematoma rates trended slightly higher in the drain group at both assessment timepoints, though neither difference reached statistical significance. The most clinically relevant finding may be the secondary one: hematoma, regardless of drainage status, carried a 29-fold increased odds of infection.

Claims

• Hematoma on postoperative day 3: 13.4% (drain) vs. 8.8% (no drain), P = .143 — not significant
• Hematoma on postoperative day 10: 16.8% (drain) vs. 13.0% (no drain), P = .298 — not significant
• Overall infection rate: 2.0%, identical between groups, P = 1.000
• Mechanical complication rate: 2.7% (drain) vs. 4.2% (no drain), P = .427 — not significant
• Hematoma significantly associated with infection: OR 29.0 at day 3 (P < .001); OR 10.6 at day 10 (P = .002)
• Hematoma associated with prosthesis malfunction: OR 4.67 (P = .014)
• Smoking and lower BMI identified as independent risk factors for hematoma on multivariate analysis

Study Quality

This is a retrospective, non-randomized comparison of 410 patients — respectable in size for penile prosthesis research, but the design introduces unavoidable selection bias. The authors don't explain why some patients received drains and others didn't, which is the central methodological problem: if surgeons placed drains in cases they judged to be at higher bleeding risk, the drain group's worse hematoma trend is confounded by indication before the analysis even begins. Ultrasonographic assessment on days 3 and 10 is a methodological strength, providing more objective hematoma detection than clinical exam alone.

The multivariate analysis is credible for the hematoma risk-factor findings (smoking, BMI), but the primary comparison — drain vs. no drain — cannot be disentangled from patient-level differences without randomization. Complex cases were excluded, which limits generalizability to straightforward primary implants only. The lack of standardized hematoma grading (size thresholds, clinical significance criteria) is a real limitation — lumping a small scrotal ecchymosis with a large expanding hematoma inflates the numerator without meaningful clinical distinction.

Red Flags

• No randomization: drain assignment appears surgeon- or case-dependent; the groups may not be comparable at baseline
• Confounding by indication: surgeons likely placed drains in cases they perceived as higher-risk, which would bias hematoma rates upward in the drain group regardless of drain efficacy
• Funding and COI not disclosed: for a procedural comparison study this is a minor concern, but the omission should be noted
• No standardized hematoma grading system: "hematoma" is clinically heterogeneous — size and clinical impact are not reported
• Retrospective design with exclusion of complex cases: results apply narrowly to straightforward penoscrotal primary implants

Strengths

• 410 patients is among the larger single-institution cohorts for this procedure
• Standardized ultrasonographic hematoma assessment at two timepoints (days 3 and 10) rather than clinical exam alone
• 12-month follow-up captures delayed mechanical complications
• Multivariate analysis for risk factor identification (smoking, BMI) adds clinically actionable secondary findings
• The hematoma-to-infection association (OR 29.0) is a genuinely important signal regardless of the drain question

Verdict

The drain question cannot be definitively answered by this study — confounding by indication likely explains most or all of the observed (non-significant) hematoma difference between groups. What the study does establish credibly is the downstream cascade: hematoma dramatically increases infection odds (OR 29), and infection risks device failure. That finding, supported by the sample size and objective imaging, is more useful than the headline comparison. This paper is worth reading for the risk-factor data and the hematoma-complication association; its conclusion about drains is plausible but unproven. A prospective randomized trial is the only way to close the question.