Does topical hemostatic agent (Floseal®) have a long-term adverse effect on erectile function recovery after nerve-sparing robot-assisted radical prostatectomy?

Int Urol Nephrol. 2017 Sep;49(9):1519-1526. doi: 10.1007/s11255-017-1645-4. Epub 2017 Jul 4.

Abstract

Objectives: To investigate the long-term effects of Floseal® on erectile function recovery (EFR) after nerve-sparing robot-assisted radical prostatectomy (RALP).

Methods: We prospectively collected results of the self-administered International Index Erectile Function Questionnaire 1-5 and 15 (IIEF 1-5 and 15) of 532 consecutive patients who underwent RALP for prostate cancer in our institution between October 2007 and December 2015. Patients were divided into two groups according to Floseal® application after prostatectomy. They were enrolled according to the following criteria: (a) bilateral nerve-sparing procedure; (b) preoperative IIEF ≥ 17; adherence to our erectile rehabilitation protocol; (c) 1-year follow-up. Outcomes were measured as mean IIEF score, EFR (IIEF < 17 or ≥17), grade of ED: severe (IIEF < 17), moderate (17-21), mild (22-25) and no ED (>25).

Results: A total of 120 patients were enrolled. Group A included 40 consecutive patients who received traditional hemostasis, and Group B included 80 consecutive patients in which Floseal® was additionally used. No differences were observed in terms of preoperative mean IIEF score (p = 0.65). Group B patients showed a trend toward a higher mean IIEF score 3 months after surgery (p = 0.06) but no differences in terms of EFR (p = 1.000). Long-term results (6, 9, 12 months after surgery) showed a significantly and progressively higher mean IIEF score (p = 0.04, 0.003, 0.003) and EFR (p = 0.043, 0.027, 0.004) in Group A patients. Comparison between the groups in terms of severe, moderate, mild and no ED becomes significant at 9 and 12 months (p = 0.002, 0.006).

Conclusion: The results of our study suggest that local use of Floseal® worsens the long-term erectile function recovery in patients selected for nerve-sparing RALP.

Keywords: Erectile function; Floseal ®; International Index of Erectile Function Questionnaire; Prostate cancer; Robot-assisted laparoscopic radical prostatectomy.

MeSH terms

  • Administration, Topical
  • Adult
  • Aged
  • Erectile Dysfunction / etiology*
  • Follow-Up Studies
  • Gelatin Sponge, Absorbable / administration & dosage
  • Gelatin Sponge, Absorbable / adverse effects*
  • Hemostatics / administration & dosage
  • Hemostatics / adverse effects*
  • Humans
  • Male
  • Middle Aged
  • Organ Sparing Treatments
  • Penile Erection / drug effects*
  • Peripheral Nerves
  • Prostatectomy / adverse effects
  • Recovery of Function / drug effects*
  • Retrospective Studies
  • Robotic Surgical Procedures / adverse effects
  • Severity of Illness Index
  • Surveys and Questionnaires

Substances

  • FloSeal Matrix
  • Hemostatics