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Enrolling by Invitation

NCT Number: NCT07159165

Registry of MIUS for Benign Prostatic Obstruction

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.

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Key information

Conditions

Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Sex eligibility

Male

Study type

Observational

Primary location

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally invasive surgical treatment for benign prostatic obstruction

Procedure

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 outcomes

  1. 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

    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 outcomes

  1. Comparison of perioperative complication rates between surgical techniques

    Time frame: up to 4 weeks

    Proportion of patients experiencing perioperative complications (Clavien-Dindo classification) following TURP, HoLEP, ThuLEP, or Rezum®

  2. Change in International Prostate Symptom Score (IPSS)

    Time frame: 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).

  3. Change in maximum urinary flow rate (Qmax)

    Time frame: Baseline to 12 months post-surgery

    Mean difference in Qmax (mL/sec) between preoperative measurement and 12-month follow-up.

  4. Reoperation-free survival

    Time frame: Up to 5 years post-surgery

    Proportion of patients not requiring repeat surgical intervention for BPO within 5 years after the index procedure.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Collaborators

  • Ankara University
  • Cukurova University
  • Dokuz Eylul University
  • Erol Olcok Corum Training and Research Hospital
  • Eskisehir Osmangazi University
  • Gazi University
  • Izmir Metropolitan Municipality Esrefpasa Hospital
  • Marmara University
  • Samsun Education and Research Hospital
  • Tepecik Training and Research Hospital

Registry information

Official study title

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

Acronym: ReMIUS-BPO

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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