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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

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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.

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Data Availability

The data would be made available upon request by corresponding author.

Abbreviations

AE:

Adverse event

AUA:

American Urological Association

BPH:

Benign prostatic hyperplasia

EAU:

European Association of Urology

FDA:

Food and Drug Administration

iTIND:

Temporarily Implanted Nitinol Device

LUTS:

Lower urinary tract symptoms

MAUDE:

Manufacturer and User Facility Device Experience

MIST:

Minimally invasive surgical therapies

OML:

Obstructive middle lobe

PAE:

Prostate artery embolization

PUL:

Prostatic urethral lift

RCT:

Randomized clinical trial

TUMT:

Transurethral microwave therapy

TUNA:

Transurethral needle ablation

TURP:

Transurethral resection of the prostate

UTI:

Urinary tract infection

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Authors and Affiliations

  1. Desai Sethi Urology Institute, University of Miami, Miller School of Medicine, Coral Gables, USA

    Joao G. Porto, Maria Camila Suarez Arbelaez, Ruben Blachman-Braun, Ramgopal Satyanarayana, Robert Marcovich & Hemendra N. Shah

  2. Seth GS Medical College and KEM Hospital, Mumbai, India

    Ansh Bhatia

  3. Department of Interventional Radiology, University of Miami, Miller School of Medicine, Coral Gables, USA

    Shivank Bhatia

Authors
  1. Joao G. Porto
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  2. Maria Camila Suarez Arbelaez
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  3. Ruben Blachman-Braun
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  4. Ansh Bhatia
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  6. Ramgopal Satyanarayana
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  7. Robert Marcovich
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Contributions

All authors contributed to the study conception and design. All authors read and approved the final manuscript. JGP contributed to data collection and manuscript writing/editing. MCSA contributed to manuscript writing/editing. RBB contributed to data analysis and manuscript writing/editing. A Bhatia contributed to manuscript writing/editing. SB contributed to manuscript writing/editing. RS contributed to manuscript writing/editing. RM contributed to manuscript writing/editing. HNS contributed to project development, data management, and manuscript writing/editing.

Corresponding author

Correspondence to Hemendra N. Shah.

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Porto, J.G., Arbelaez, M.C.S., Blachman-Braun, R. et al. 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. World J Urol 41, 1975–1982 (2023). https://doi.org/10.1007/s00345-023-04440-w

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