NCT07159165

Registry of MIUS for Benign Prostatic Obstruction

Minimal Invasive Urology Society Benign Prostatic Obstruction (BPO) Study Group Data Collection Project

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Ondokuz Mayıs University · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive surgical treatment for benign prostatic obstruction	Surgical management of BPO using contemporary minimally invasive procedures, including but not limited to: Transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), Thulium laser enucleation of the prostate (ThuLEP), Rezum® water vapor thermal therapy. Procedures are performed according to standard clinical practice at each participating center, with perioperative and follow-up data prospectively recorded in the MIUS registry.

Timeline

• Start date: 2025-07-01
• Primary completion: 2030-07-01
• Completion: 2035-07-01
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: Turkey (Türkiye)