ADELMIDROL AND TRANS-TRAUMATIC ACID IN PATIENTS WITH URETHRAL PAIN SYNDROME: PRELIMINARY OBSERVATIONS

E. Ostardo, C. Bignù, N. Lampropoulou | Neurourology and Rare Urological Diseases Unit – Urology Unit of the Santa Maria Degli Angeli Hospital, Pordenone

INTRODUCTION
Urethral Pain Syndrome (UPS) primarily affects women and significantly impacts patients' quality of life. It is characterized by persistent or recurrent urethral pain, mainly on voiding¹. Although etiology is still not fully understood, a leading theory suggests a dysfunction of the mucosal barrier, as a result of inflammatory and oxidative damage to the macromolecular components, like elastic fibers and hyaluronic acid². Adelmidrol (ADM) is an azelaic acid derivative and a palmitoylethanolamide analogue³. Notably, ADM has been shown to protect hyaluronan against oxidative depolymerization⁴. Trans-traumatic acid (TTA) is a re-epithelializing plant-origin monounsaturated dicarboxylic acid⁵. It regulates zinc availability, thus controlling zinc-dependent enzymes involved in tissue healing⁶. Here we report the intraurethral use of an ADM-TTA-based medical device in patients with UPS.
METHODS
Ten eighteen-year-old or older females with pre/post-void pain ≥4 cm on VAS for at least 1 year were selected, provided they did not experience prior genitourinary surgery, infection or malignancy. A 5-day daily intraurethral administration of the ADM-TTA medical device (Epinorm®, Epitech Group, Milan) was performed via catheterization by trained outpatient nursing staff and supervised by a medical professional. Urethral pain was assessed on VAS before each administration (T0-T4) and one- and three-month follow-up after the last administration (T5 and T6, respectively). At T0 and T5 a standard uroflowmetry was performed, with values of the maximum and average flow rate (Qmax and Qave, respectively) being obtained. At the same timepoints, patients underwent flexible cystoscopy, and macroscopic signs were scored on a 0(absent)-3(very severe) scale. Differences over time were analyzed with a generalized linear mixed model or Wilcoxon signed-rank test, as appropriate. Data are expressed as mean±SEM. The limit of significance was set at P<0.05.
RESULTS
Inter-void pain significantly decreased over time (P=0.009), from 5.2±0.51 (T0) to 2.1±1.39 (T6). Post-void pain was also significantly reduced (P=0.015), decreasing from 5.3±0.82 (T0) to 1.9±1.24 (T6). A clear decrease of Qmax (from 26.2±4.34 to 17±2.11) and Qave (from 13.9±2.22 to 8.2±1.21, P=0.037) was observed, although the former did not reach statistical significance. At flexible cystoscopy, a significant decrease of edema (P=0.004), erythema (P=0.016), bleeding upon minimal manipulation (P=0.004), mucosal friability (P=0.008) and urethral wall contracture (P=0.002) were observed compared to baseline (Figure 1).
CONCLUSIONS
The present findings highlight the long-term effect of ADM and TTA intraurethral administration in reducing pain as well as signs of urethral damage and dysfunction. The effects may result from restoration of mucosal barrier function by ADM and TTA. Although well-designed studies are warranted, these preliminary observations pave the way to the possible intraurethral use of ADM and TTA for pain relief in patients with UPS.