Benign Prostatic Hyperplasia With Lower Urinary Tract SymptomsReMIUS-BPONCT07159165
Registry of MIUS for Benign Prostatic Obstruction
An observational study of Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
- What is being tested?
- Minimally invasive surgical treatment for benign prostatic obstruction
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Jul 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- No informed consent
- Missing essential preoperative or follow-up data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Minimal Invasive Urology Society Benign Prostatic Obstruction (BPO) Study Group Data Collection Project
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.
Read the 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:
- 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.
- Being tested
- Minimally invasive surgical treatment for benign prostatic obstruction
- 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
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgical treatment for benign prostatic obstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Minimally invasive surgical treatment for benign prostatic obstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 months after each patient's surgery date
Secondary outcomes (4)
Comparison of perioperative complication rates between surgical techniques
Proportion of patients experiencing perioperative complications (Clavien-Dindo classification) following TURP, HoLEP, ThuLEP, or Rezum®
Measured: up to 4 weeks
Change in International Prostate Symptom Score (IPSS)
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).
Measured: 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.
Measured: 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.
Measured: Up to 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia With Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Murat Gulsen, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159165
- Sponsor's protocol ID
- MIUS.2025.001
- Acronym
- ReMIUS-BPO
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive Urology Society Benign Prostatic Obstruction (BPO) Study Group Data Collection Project
- ClinicalTrials.gov ID
- NCT07159165
- Acronym / sponsor ID
- ReMIUS-BPO / MIUS.2025.001
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2035 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing minimally invasive surgical treatment for BPO | – | Procedure: Minimally invasive surgical treatment for benign prostatic obstructionAll eligible male patients with a diagnosis of BPO undergoing procedures such as TURP, HoLEP, ThuLEP, Rezum®, or similar minimally invasive techniques will be included. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- No informed consent
- Missing essential preoperative or follow-up data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive surgical treatment for benign prostatic obstructionSurgical 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. | Procedure or surgery | Patients undergoing minimally invasive surgical treatment for BPO |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No. 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.
Related trials for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Enrolling by invitation
Emsella for Reducing tSUI After HOLEP
Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms
Active, not recruiting
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.