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Enrolling by invitation NCT07159165

Registry of MIUS for Benign Prostatic Obstruction

— Observational Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Minimally invasive surgical treatment for benign prostatic obstruction.
Who it may be relevant to
Registry conditions: Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms. Basic parameters: No limits · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Proportion of eligible BPO surgery patients successfully enrolled with complete baseline, perioperative, and follow-up data in the MIUS registry [Time frame: Within 12 months after each patient's surgery date]
Secondary outcome measures (4)
  • Comparison of perioperative complication rates between surgical techniques [Time frame: up to 4 weeks]
  • Change in International Prostate Symptom Score (IPSS) [Time frame: Baseline to 12 months post-surgery]
  • Change in maximum urinary flow rate (Qmax) [Time frame: Baseline to 12 months post-surgery]
  • Reoperation-free survival [Time frame: Up to 5 years post-surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Ondokuz Mayıs University — Samsun

Identifiers

NCT: NCT07159165 · MIUS.2025.001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗