Comparison of Soltive™ (thulium fiber) laser enucleation of the prostate (SoLEP) versus holmium laser enucleation of the prostate (HoLEP) in Benign Prostate Syndrome (BPS) - a prospective randomized non-inferiority study

Comparison of Soltive™ (thulium fiber) laser enucleation of the prostate (SoLEP) versus holmium laser enucleation of the prostate (HoLEP) in Benign Prostate Syndrome (BPS) - a prospective randomized non-inferiority study - SOLT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00032699

Enrollment

152

Registered

2023-09-18

Start date

2021-10-01

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

N40

Interventions

Group 1: Patients receive the classic HoLEP as a surgical procedure. Group 2: The patients receive the new SoLEP as a surgical procedure.

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Indication for subvesical deobstruction

Exclusion criteria

Exclusion criteria: Prostate less than or equal to 30ccm, urethral stricture, punch biopsy confirmed carcinoma of the prostate, preoperative evidence of prostate carcinoma, neurogenic bladder emptying disorder

Design outcomes

Primary

Measure	Time frame
postoperative difference in micturition symptoms, which will be collected using the International Prostate Symptom Score (IPSS) and Quality of Life (QoL) questionnaires at inclusion in the study and 3, 6, 12 and 24 months postoperatively	—

Secondary

Measure	Time frame
complications, uroflow (Qmax), residual urine, operating times, catheter time, hospital length of stay and sexual/ejaculatory function	—

Countries

Germany

Contacts

Public ContactBecker Andreas

Universitätsklinikum Frankfurt Klinik für Urologie

Andreas.Becker@kgu.de069 6301-5865

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 30, 2026