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Review
. 2023 Jul;41(7):1975-1982.
doi: 10.1007/s00345-023-04440-w. Epub 2023 May 24.

Complications associated with minimally invasive surgical therapies (MIST) for surgical management of benign prostatic hyperplasia: a Manufacturer and User Facility Device Experience (MAUDE) database review

Joao G Porto  1 , Maria Camila Suarez Arbelaez  1 , Ruben Blachman-Braun  1 , Ansh Bhatia  2 , Shivank Bhatia  3 , Ramgopal Satyanarayana  1 , Robert Marcovich  1 , Hemendra N Shah  4
Affiliations
Review

Complications associated with minimally invasive surgical therapies (MIST) for surgical management of benign prostatic hyperplasia: a Manufacturer and User Facility Device Experience (MAUDE) database review

Joao G Porto et al. World J Urol. 2023 Jul.

Abstract

Purpose: MAUDE database houses medical device reports of suspected device-related complications received by Food and Drug Administration. In the present study we aim to evaluate the MAUDE database for reported complications of MIST procedures.

Methods: The database was queried using keywords: rezum, urolift, prostate embolization (PAE), transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), prostate stent and Temporarily Implanted Nitinol Device (iTIND) on 10/1/22 to extract information regarding device problems and procedure-related complications. Gupta classification system was used to stratify complications. Statistical analysis was performed to compare frequency of complications among MIST procedures.

Results: We found a total of 692 reports (Rezum-358, urolift-226, PAE-53, TUNA-31, TUMT-19, prostatic stent-4, and iTIND-1). Most complications related to device or users were minor (level 1 and 2) and there was no significant difference among various MIST procedures. The screen/system error was responsible for 93% and 83% aborted cases in Rezum and TUNA, respectively, and PAE showed 40% of device component detachment/fracture. Overall Urolift and TUMT were associated with statistically significant higher incidence of major (level 3 and 4) complications (23% and 21%, respectively) as compared with Rezum (7%). Most major complications needing hospitalization after Urolift included hematoma and hematuria with clots and those after Rezum included urinary tract infection and sepsis. Thirteen deaths were reported, mostly due to cardiovascular events, which were classified as not associated with the proposed treatment.

Conclusion: MIST for BPH can occasionally cause significant morbidity. Our data should assist urologists and patients in shared decision-making process.

Keywords: Benign prostatic hyperplasia; Complications; Enlarged prostate; Minimally invasive surgical therapy; Rezum; Urolift.

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Comment in

  • Benign Prostatic Hyperplasia.
    Kaplan SA. Kaplan SA. J Urol. 2023 Dec;210(6):908-910. doi: 10.1097/JU.0000000000003714. Epub 2023 Sep 25. J Urol. 2023. PMID: 37747152 No abstract available.

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