Registry of MIUS for Benign Prostatic Obstruction (ReMIUS-BPO)

Ondokuz Mayıs University

Status: Invitation-only

Conditions: Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

Treatments: Procedure: Minimally invasive surgical treatment for benign prostatic obstruction

Study type: Observational

Funder types: Other

Identifiers

NCT07159165

MIUS.2025.001

Details and patient eligibility

About

This national, multicenter, prospective registry aims to collect standardized perioperative and follow-up data on patients undergoing minimally invasive surgical management for benign prostatic obstruction (BPO) in Turkey. Procedures include transurethral resection of the prostate (TURP), holmium/thulium laser enucleation (HoLEP/ThuLEP), Rezum®, and other contemporary techniques. By prospectively recording patient characteristics, surgical details, and postoperative outcomes in a unified electronic database, the project seeks to provide high-quality real-world evidence to support clinical decision-making, guideline updates, and future hypothesis-driven sub-studies.

Full description

The ReMIUS-BPO registry is designed as a prospective, observational, multicenter cohort study under the coordination of the Minimal Invasive Urology Society. Participating centers will record preoperative, intraoperative, and postoperative data of patients undergoing minimally invasive surgery for BPO using a secure, standardized electronic case report form. Preoperative variables include demographics, comorbidities, medication history, prostate volume, and validated symptom scores (IPSS, OAB-V8). Intraoperative data include surgical technique, energy source, operative time, and complications. Postoperative follow-up will record early and late complications, catheterization time, changes in symptom scores, and re-intervention rates.

The registry aims to:

1. Create a comprehensive, analyzable national dataset for BPO surgery.
2. Compare surgical outcomes between different energy sources.
3. Evaluate the impact of the learning curve on operative time.
4. Determine long-term reoperation rates. The data will serve as a platform for future hypothesis-driven studies and potential embedded randomized controlled trials.

Enrollment: 10,000 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients ≥ 18 years old
• Diagnosis of BPO with clinical indication for minimally invasive surgery
• Signed informed consent
• Availability of complete baseline and follow-up data

Exclusion criteria

• No informed consent
• Missing essential preoperative or follow-up data

Trial design

10,000 participants in 1 patient group

Patients undergoing minimally invasive surgical treatment for BPO

Description:

All eligible male patients with a diagnosis of BPO undergoing procedures such as TURP, HoLEP, ThuLEP, Rezum®, or similar minimally invasive techniques will be included.

Treatment:

Procedure: Minimally invasive surgical treatment for benign prostatic obstruction