Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ankara University | OTHER |
| Dokuz Eylul University | OTHER |
| Erol Olcok Corum Training and Research Hospital | OTHER |
| Gazi University |
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of perioperative complication rates between surgical techniques | Proportion of patients experiencing perioperative complications (Clavien-Dindo classification) following TURP, HoLEP, ThuLEP, or Rezum® | up to 4 weeks |
| Change in International Prostate Symptom Score (IPSS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ondokuz Mayıs University | Samsun | Turkey (Türkiye) |
Individual participant data (IPD) will not be shared due to privacy concerns and data protection regulations, including the Turkish Personal Data Protection Law (KVKK). Only aggregated, de-identified results will be reported in publications and presentations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2025 | Aug 28, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 24, 2025 | Aug 28, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| OTHER |
| Eskisehir Osmangazi University | OTHER |
| Marmara University | OTHER |
| Samsun Education and Research Hospital | OTHER |
| Cukurova University | OTHER |
| Izmir Metropolitan Municipality Esrefpasa Hospital | OTHER |
| Tepecik Training and Research Hospital | OTHER |
Not provided
Not provided
Not provided
|
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). |
| Baseline to 12 months post-surgery |
| Change in maximum urinary flow rate (Qmax) | Mean difference in Qmax (mL/sec) between preoperative measurement and 12-month follow-up. | Baseline to 12 months post-surgery |
| Reoperation-free survival | Proportion of patients not requiring repeat surgical intervention for BPO within 5 years after the index procedure. | Up to 5 years post-surgery |