Comparison of laser enucleation of the prostate in benign prostatic hyperplasia with versus without the HoloLase MD glasses – a prospective randomized study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039080

Enrollment

122

Registered

2026-05-27

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

N40

Interventions

Group 1: The patients receive the novel HoLEP surgical procedure with visualization via HoloLase MD glasses (intervention group). Group 2: The patients receive the conventional HoLEP surgical procedur

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Indication for laser enucleation of the prostate and signed informed consent form

Exclusion criteria

Exclusion criteria: - Prostate volume less than or equal to 30 cc - Urethral stricture - Preoperative confirmation or indication of prostate cancer - Confirmed neurogenic bladder dysfunction

Design outcomes

Primary

Measure	Time frame
Enucleation efficiency/time (intraoperative documentation)	—

Secondary

Measure	Time frame
- Intraoperative and 30-day complication rates (questionnaires and patient record review) - Overall surgical efficiency/time (intraoperative documentation) - Catheterization duration (patient record review) - Satisfaction of the surgeon (questionnaire) - Functional endpoints (questionnaires)	—

Countries

Germany

Contacts

Public ContactMarina Kosiba

Universitätsmedizin Frankfurt, Klinik für Urologie

marina.kosiba@unimedizin-ffm.de069 6301-5865

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026