MULTICENTER EXPERIENCE WITH A TEMPORARY IMPLANTABLE NITINOL DEVICE FOR THE MANAGEMENT OF LOWER URINARY TRACT SYMPTOMS: SHORT TERM RESULTS ON FUNCTIONAL SCORES

Castellucci R1, Secco S2, Olivero A2, Galfano A2, Dell'Oglio P2, Al Jaafari F3, Khadhouri S3, Alessio F4, Cindolo L1

Research Type

Clinical

Abstract Category

Male Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

Abstract 582
Open Discussion ePosters
Scientific Open Discussion Session 105
Thursday 24th October 2024
14:45 - 14:50 (ePoster Station 2)
Exhibition Hall
Benign Prostatic Hyperplasia (BPH) Male Sexual Dysfunction Surgery
1. Department of Urology, "Villa Stuart" Private Hospital, Rome, Italy and Department of Urology, "Hesperia Hospital", and CURE Group, Modena, Italy, 2. Department of Urology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.,, 3. Urology Department, NHS Fife, Scotland, UK, 4. Department of Urology, "Villa Stuart" Private Hospital, Rome, Italy
Presenter
Links

Poster

Abstract

Hypothesis / aims of study
Lower urinary tract symptoms (LUTSs) due to benign prostatic hyperplasia (BPH) represent a frequent and condition affecting ageing men. Transurethral resection of the prostate (TURP) represents the gold standard surgical treatment but is not devoid of complications like retrograde ejaculation, bleeding and urinary retention. i-TIND, a temporary implantable nitinol device, is considered among the minimally invasive surgical techniques one of the best alternatives to control LUTS with a full preservation of sexual functions.  Here we report the results of a multicenter real-life study.
Study design, materials and methods
We collected data in 3 european centres.  Patients with LUTS from BPH were treated with the I-TIND device. We recorded variations in International Prostate Symptom Score (IPSS), change in quality of life score (QoL), International Index of Erectile Function (IIEF5), maximum flow rate (QMax), post-void residual urine volume (PVR) and freedom from repeat intervention in short term.
Results
A total of 48 subjects were enrolled and treated; median follow-up was 9 months. Mean age and prostate volume were 49y and 30ml respectively . IPSS and QoL changed from a mean of 20 and 4 points at baseline to 3 and 1.5 points respectively at the last follow-up. We recorded an improvement in Qmax and PVR from 9 ml/sec and 75 ml at baseline to 13 ml/sec and 0 ml at the last follow-up. Total median operative time was 10 min,  the median time of i-TIND application was 7 days and median device remove time was 5min.  There was no impact on sexual functions (no changes in IIEF5 scores and antegrade ejaculation rate).
We did not have intra operative complications, wherever not serious postoperative complications occurred in 6 patients (2 urinary retention, 2 mild hematuria, 2 cases with urinary infection) . Finally,  4 patients underwent reoperation during follow-up. In  all patients the procedure was carried out in a day hospital setting. Five patients required pain management with opioids in the first postoperative week.
Interpretation of results
Benign prostatic hyperplasia (BPH) is a common problem among  men and can have a significant impact on their quality of life (1). The side effects associated with drugs, and potential risks  inherent in invasive surgery are of a great concern to many patients and may deter them from adhering to, or pursuing treatment for BPH (2). The results of this multi-center study
confirms that the treatment with the iTIND is effective in terms of improving urinary symptoms and the patient's quality of life, in line with literature data.
Concluding message
The amelioration in terms of urinary and sexual symptom scores supported us to offer i-TIND as a valid option in the management of men with LUTS/BPH. Longer follow-up are required in order to better define the durability of this minimally invasive procedure.
References
  1. Sun Y, Peng B, Lei GL, Wei Q, Yang L. Study of phosphodiesterase 5 inhibitors and a-adrenoceptor antagonists used alone or in combination for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Minerva Urol Nefrol. 2020;72:13–21.
  2. Amparore D, Fiori C, Valerio M, Schulman C, Giannakis I, De Cillis S, Kadner G, Porpiglia F. 3-Year results following treatment with the second generation of the temporary implantable nitinol device in men with LUTS secondary to benign prostatic obstruction. Prostate Cancer Prostatic Dis. 2021 Jun;24(2):349-357. doi: 10.1038/s41391-020-00281-5. Epub 2020 Oct 1. PMID: 33005003.
Disclosures
Funding no Clinical Trial No Subjects Human Ethics Committee Ospedale Hesperia Modena
03/04/2025 03:31:31