Registry of MIUS for Benign Prostatic Obstruction

NCT07159165 | Enrolling By Invitation

• 1 other identifier: MIUS.2025.001
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

Keywords

Benign Prostatic Obstruction; Lower Urinary Tract Symptoms; Prostatic Surgery; Transurethral Resection of the Prostate; Holmium Laser Enucleation of the Prostate; Thulium Laser Enucleation of the Prostate; Rezum; Minimally Invasive Surgery; Laser Enucleation; Prostate Endoscopic Surgery; Urology; Prospective Registry; Multicenter Study; BPO; LUTS; TURP; HoLEP; ThuLEP

Outcome Measures

Primary Outcomes (1)

• Proportion of eligible BPO surgery patients successfully enrolled with complete baseline, perioperative, and follow-up data in the MIUS registry

  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.

  Within 12 months after each patient's surgery date

Secondary Outcomes (4)

• Comparison of perioperative complication rates between surgical techniques

  up to 4 weeks

• Change in International Prostate Symptom Score (IPSS)

  Baseline to 12 months post-surgery

• Change in maximum urinary flow rate (Qmax)

  Baseline to 12 months post-surgery

• Reoperation-free survival

  Up to 5 years post-surgery

Study Arms (1)

Patients undergoing minimally invasive surgical treatment for BPO

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.

Procedure: Minimally invasive surgical treatment for benign prostatic obstruction

Interventions

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.

Patients undergoing minimally invasive surgical treatment for BPO

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male patients (≥18 years) diagnosed with benign prostatic obstruction (BPO) and scheduled to undergo minimally invasive surgical treatment at participating centers. The registry will include consecutive eligible patients treated with procedures such as transurethral resection of the prostate (TURP), holmium laser enucleation of the prostate (HoLEP), thulium laser enucleation of the prostate (ThuLEP), Rezum®, or other contemporary surgical techniques, according to routine clinical practice.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: September 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2035
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)