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Prospective randomized study on non-inferiority analysis/equivalence analysis of the surgical procedures GreenLight and Rezum for benign prostatic hyperplasia (AG BPH)

Prospective randomized study on non-inferiority analysis/equivalence analysis of the surgical procedures GreenLight and Rezum for benign prostatic hyperplasia (AG BPH) - AG BPH

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034013
Enrollment
160
Registered
2024-04-08
Start date
2024-01-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N40

Interventions

Group 1: REZUM BPH Therapy Group 2: Greenlight BPH Therapy

Sponsors

Charite- Universitätsmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Capacity to consent

Exclusion criteria

Exclusion criteria: younger 18, female

Design outcomes

Primary

MeasureTime frame
REZUM demonstrates non-inferiority in subvesical deobstruction compared to GreenLight for <80cc prostates. Difference in IPSS + QoL (pre-operative to 30 days post-operative). Difference in IPSS + QoL (pre-operative to 1 year post-operative).—

Secondary

MeasureTime frame
REZUM demonstrates non-inferiority in subvesical deobstruction compared to GreenLight for >80cc prostates. Retrograde Ejaculation Recurrence of urinary retention (on XXth post-operative day) Successful catheter removal (on XXth post-operative day) Clavien-Dindo III-V (clinically relevant) Recurrent infections Surgical duration (to be differentiated in the table) Discharge (on XXth post-operative day)—

Countries

Germany

Contacts

Public ContactMaximilian Reimann

Charite- Universitätsmedizin Berlin

maximilian.reimann@charite.de+4930450615249

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026