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Post-Surgical Complications After Bladder Outlet Reducing Surgery: An Analysis of The FDA Manufacturer and User
Jason K Weiss1, Nicole M Santucci1, Kamran P Sajadi2
1School of Medicine, Oregon Health & Science University.
Objective:
To examine voluntary reports in the Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, categorize complications and assign device-related causality with transurethral resection of the prostate (TURP), prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT).
Methods:
A review was performed using the terms "Urolift," "Rezum," and "transurethral resection of the prostate" between 01/01/2015 and 12/31/2019. Duplicate and incomplete reports were excluded. The Gupta system was used to report complications and device related causality.1 Pearson's Chi-square analysis was performed to compare minor (Level 1) versus major (Levels 2-4) complications.
Results:
A total of 548 events were examined. After removal of duplicates (n = 60), irrelevant reports (n=65), and incomplete information (n = 14), we included 409 events (74.6%). Of the 409 events, 214 were for TURP, 112 for TWVT, and 83 for PUL. In aggregate, 39.4% of events were minor/Level 1 (n=161/409). The proportion of subjects with Level 2-4 complications versus Level 1 complications was significantly higher for PUL than TURP or TWVT [X2 (2, N = 408) = 41.4023, P < .00001]. Device causality was attributable to device malfunction in 60.4% of cases (n=247/409).
Conclusion:
Device malfunction was noted in all groups and 39.4% of these were minor (Level 1). However, the majority of PUL reports noted a Level 3 or 4 complication (50.6%, 42/83), primarily bleeding related. Previous studies have not revealed significant risk of bleeding and suggests a discrepancy between study data and real-world experience that may alter patient counseling practices.
Insights
Prostatic urethral lift (PUL) shows a higher rate of major complications like bleeding compared to transurethral resection of the prostate (TURP) and transurethral water vapor therapy (TWVT). Device malfunction is common across all procedures, impacting real-world patient counseling.
Area of Science:
- Urology
- Medical Device Safety
Background:
- The Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database collects voluntary reports on medical device performance.
- Transurethral resection of the prostate (TURP), prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT) are common BPH treatments with varying complication profiles.
Purpose of the Study:
- To analyze voluntary reports in the FDA MAUDE database for TURP, PUL, and TWVT.
- To categorize complications and assess device-related causality for these BPH treatments.
Main Methods:
- A review of the MAUDE database was conducted for "Urolift," "Rezum," and "transurethral resection of the prostate" from 01/01/2015 to 12/31/2019.
- Complications and device causality were assessed using the Gupta system, with Pearson's Chi-square analysis comparing minor versus major complications.
Main Results:
- Of 409 included reports, 214 were for TURP, 112 for TWVT, and 83 for PUL.
- Prostatic urethral lift (PUL) had a significantly higher proportion of major complications (Levels 2-4) compared to TURP and TWVT.
- Device malfunction was cited in 60.4% of all events, with 39.4% being minor complications.
Conclusions:
- Prostatic urethral lift (PUL) is associated with a higher rate of severe complications, particularly bleeding, in real-world data compared to TURP and TWVT.
- Discrepancies between real-world data and prior study findings for PUL suggest a need to update patient counseling practices.
- Device malfunction is a significant factor across all evaluated BPH treatment modalities.
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