Registry of MIUS for Benign Prostatic Obstruction

• Conditions: Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

• Registration Number: NCT07159165
• Lead Sponsor: Ondokuz Mayıs University

Brief 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.

Study Timeline

• Study Start: 2025-07-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-08
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2030-07-01
• Study Completion: 2035-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of eligible BPO surgery patients successfully enrolled with complete baseline, perioperative, and follow-up data in the MIUS registry	Within 12 months after each patient's surgery date	Percentage of eligible patients undergoing minimally invasive surgical treatment for BPO whose data sets are complete for all predefined variables (baseline characteristics, perioperative details, and follow-up outcomes) in the national MIUS registry. Completeness is defined as ≥95% of required data fields filled for each case.

Secondary Outcome Measures

Name	Time	Method
Comparison of perioperative complication rates between surgical techniques	up to 4 weeks	Proportion of patients experiencing perioperative complications (Clavien-Dindo classification) following TURP, HoLEP, ThuLEP, or Rezum®
Change in International Prostate Symptom Score (IPSS)	Baseline to 12 months post-surgery	Mean change in International Prostate Symptom Score (IPSS) from baseline to 12 months in patients undergoing minimally invasive surgical treatment for benign prostatic obstruction (BPO).; The IPSS ranges from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms (worse outcome).
Change in maximum urinary flow rate (Qmax)	Baseline to 12 months post-surgery	Mean difference in Qmax (mL/sec) between preoperative measurement and 12-month follow-up.
Reoperation-free survival	Up to 5 years post-surgery	Proportion of patients not requiring repeat surgical intervention for BPO within 5 years after the index procedure.

Trial Locations

Locations (1)

Ondokuz Mayıs University; Samsun, Turkey (Türkiye)