Patient Satisfaction and Decision Regret in Patients Undergone Temporary Implantable Nitinol Device Procedure for BPH/LUTS: An Italian,Real Life,Multicenter Study

Abstract

Background:

The temporary implantable nitinol device (iTIND) has emerged as a minimally invasive surgical technique aimed at improving symptoms while preserving erectile and ejaculatory function. Although functional outcomes and safety have been extensively studied, no previous research has specifically evaluated patient satisfaction and treatment regret.

Objective:

To assess functional outcomes, treatment satisfaction, and decision regret in patients undergoing iTIND implantation in a real-life multicenter setting.

Methods:

We retrospectively analyzed prospectively collected data from 140 patients treated with iTIND at 7 institutions between January 2022 and December 2023. Baseline evaluations included International Prostatic Symptom Score (IPSS), International Prostatic Symptom Score-quality of life (IPSS-QoL), urinary peak flow (Qmax), post voiding residual (PVR), and International Index of Erectile Function score (IIEF5). Antegrade ejaculation was recorded before and after treatment. Adverse events and retreatments were monitored. At 12 months, decision regret was assessed using the validated Decision Regret Scale (DRS). Logistic regression a less absolute shrinkage and selection operator models were applied to identify predictors of high regret (DRS >25).

Results:

Median age was 52 years and median prostate volume was 30 mL. All procedures were successfully completed with same-day discharge. Functional outcomes significantly improved: IPSS decreased from 20 to 10 (p < 0.001), QoL from 4 to 2 (p < 0.001), Qmax increased from 8.5 to 13 mL/s (p < 0.001), and PVR from 52.5 to 20 mL (p = 0.013). Erectile function remained stable (IIEF5: 24 vs 26, p = 0.38), and antegrade ejaculation was preserved in most patients (78% vs 81%). At 12 months, 32% of patients (45/140) experienced high regret, while 68% (95/140) reported low regret. In multivariate analysis, early complications and retreatments were strong predictors of regret, whereas lower baseline Qmax was protective.

Conclusions:

iTIND provides significant clinical improvement with preservation of sexual function in men with LUTS/BPO. However, approximately one-third of patients reported high regret at 12 months, mainly linked to complications and retreatments. These findings stress the importance of integrating patient-reported outcomes, including regret, into the evaluation of minimally invasive therapies.