LONG TERM FOLLOW-UP OF AN INTERNATIONAL MULTICENTER PROSPECTIVE STUDY IN APPLICATION OF TEMPORARY IMPLANTABLE NITINOL DEVICE (ITIND) IN MEN WITH LOWER URINARY TRACT SYMPTOMS FOR BPH
Journal of Urology
; 207(SUPPL 5):e1037-e1038, 2022.
Article
in English
| EMBASE | ID: covidwho-1886528
ABSTRACT
INTRODUCTION AND OBJECTIVE:
To report IPSS, QoL and treatment failure rate up to 79-months for the MT02 study with implantation of the temporary implantable nitinol device (iTind;Medi- Tate Ltd®, Israel) in men with lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO).METHODS:
Three out of nine international centers consented to continue the international prospective multicenter study on patients with LUTS due to BPO (IPSS ≥10, Qmax <12ml/sec, and prostate volume <75ml) beyond 36 months following implantation of iTind. Out of the originally enrolled 81 patients, 50 were followed-up at sites in Italy, Switzerland, and Belgium. Due to Covid-19 the originally planned follow-up scheme was amended Each patient was assessed once during a timeframe of 50-79 months post-operatively by IPSS and IPSS-QoL, change in medication and adverse events via a telephone call. Patients were analyzed in three groups according to their follow-up time point (clustered into groups from 48-59 months, 60-71 months, and 72-83 months).RESULTS:
Fifty to 79 months results were available for 42 patients. Four patients were lost to follow-up and two patients deceased from reasons unrelated to the iTind device. Only two patients had treatment failures (one patient underwent TURP, the other ThuLEP), while no patient required any additional medication. IPSS average results were 12.63±8.84 (50-59m, N=24), 8.85±5.54 (60-71m, N =13) and 9.20 ±5.85 (72-79m, N=5). QoL average results were 2.21±1.69 (50-59m, N=24), 1.85±0.99 (60-71m, N=13) and 1.80±1.10 (72-79m, N=5). IPSS (-8.88, -10.31, and -9.60) and IPSSQoL (-2.04, -1.85 and -1.80) improved significantly for all groups vs. baseline, respectively (p <0.0001). Functional data is shown in Figure 1. No late post-operative complications were observed between 50 and 79 months.CONCLUSIONS:
iTind for treatment of LUTS secondary to BPO is an effective and safe procedure providing significant and effective reduction in symptoms and quality of life durable up to 79 months (6.6 years) with only 4% of treatment failures after 3-year follow-up. (Figure Presented).
nitinol; adult; adverse drug reaction; Belgium; clinical assessment; complication; conference abstract; coronavirus disease 2019; follow up; human; implantation; International Prostate Symptom Score; Italy; lower urinary tract symptom; major clinical study; male; multicenter study; postoperative complication; prospective study; prostate hypertrophy; prostate volume; quality of life; side effect; Switzerland; telephone; treatment failure
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Type of study:
Cohort study
/
Observational study
/
Prognostic study
Topics:
Long Covid
Language:
English
Journal:
Journal of Urology
Year:
2022
Document Type:
Article
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