Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Conditions
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
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.
Interventions
PROCEDUREMinimally 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.
Sponsors
Ankara University
Dokuz Eylul University
Erol Olcok Corum Training and Research Hospital
Gazi University
Eskisehir Osmangazi University
Marmara University
Samsun Education and Research Hospital
Cukurova University
Izmir Metropolitan Municipality Esrefpasa Hospital
Tepecik Training and Research Hospital
Ondokuz Mayıs University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed