BPH (Benign Prostatic Hyperplasia)Phase 4VektorNCT07204002
Comparison of Convective Water Vapor Ablation (Convective Water Vapor Energy, WAVE™) With the Rezum™ System Versus Holmium Laser Enucleation of the Prostate (HoLEP) Versus Bipolar Transurethral Resection of the Prostate (TUR-P) in Patients With Benign Prostatic Syndrome (BPS) - A Randomized Study
A Phase 4 study testing Treatment BPH in people with BPH (Benign Prostatic Hyperplasia) and HoLEP, run by Medical University of Graz.
Trial summary
Benign prostatic enlargement (BPH/BPS) is one of the most common benign diseases in adult men. About 50% of men are affected by the age of 50, and between the ages of 70 and 80 the prevalence rises to 70-80%. There are various surgical procedures available for the treatment of BPH. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia), HoLEP, Rezum
- What is being tested?
- Treatment BPH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2025to 15 Oct 2030
- Phase
- Phase 4
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patients with confirmed benign prostatic syndrome for whom surgical therapy is indicated
- Prostate volume between 30 and 80 ml
Who cannot join
- Lack of capacity to give informed consent
- Emergency surgeries
- Known prostate carcinoma
- Elevated post-void residual urine > 300 ml
- Neurogenic bladder emptying disorder
- Urethral pathologies
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- High-intensity anticoagulation
- Dual antiplatelet therapy
- History of pelvic radiation
- Chronic pelvic pain syndrome
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Benign prostatic enlargement (BPH/BPS) is one of the most common benign diseases in adult men. About 50% of men are affected by the age of 50, and between the ages of 70 and 80 the prevalence rises to 70-80%.
There are various surgical procedures available for the treatment of BPH. In this study, we are investigating three surgical procedures which, based on the current data, appear to be relatively equivalent; however, additional data are still needed to substantiate this.
Read more
The aim of this study is to compare the three surgical methods REZUM vs. HoLEP vs. TUR-P for endoscopic transurethral subvesical de-obstruction with regard to both subjective and objective voiding function, as well as improvements in quality of life and sexual function.
The goal of the study is to work out the possible advantages and disadvantages for future patient counseling, thereby defining more precisely the role of these surgical procedures within the armamentarium of urology. This is a single-center, randomized, prospective interventional study.
- Conditions
- BPH (Benign Prostatic Hyperplasia), HoLEP, Rezum, TURP(Transurethral Resection of Prostate)
- Being tested
- Treatment BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment BPHProcedure or surgery
We compare 3 different types of BPH surgery - HoLEP vs. TURP vs. REZUM
| Study group | Role | What they receive |
|---|---|---|
| TURP | Active comparator | Not described Receives: Procedure: Treatment BPH |
| HOLEP | Active comparator | Not described Receives: Procedure: Treatment BPH |
| REZUM | Active comparator | Not described Receives: Procedure: Treatment BPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of the surgical techniques in symptom improvement, determined by the change (delta) in the International Prostate Symptom Score (IPSS) at 1 month compared to baseline IPSS.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start15 Nov 2025 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Österreichische Gesellschaft für Urologie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204002
- Sponsor's protocol ID
- EK Nr: 1208/2024
- Acronym
- Vektor
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Convective Water Vapor Ablation (Convective Water Vapor Energy, WAVE™) With the Rezum™ System Versus Holmium Laser Enucleation of the Prostate (HoLEP) Versus Bipolar Transurethral Resection of the Prostate (TUR-P) in Patients With Benign Prostatic Syndrome (BPS) - A Randomized Study
- ClinicalTrials.gov ID
- NCT07204002
- Acronym / sponsor ID
- Vektor / EK Nr: 1208/2024
- Conditions
- BPH (Benign Prostatic Hyperplasia), HoLEP, Rezum, TURP(Transurethral Resection of Prostate)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Österreichische Gesellschaft für Urologie
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2030 (estimated)
- First posted
- 2 Oct 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.
Benign prostatic enlargement (BPH/BPS) is one of the most common benign diseases in adult men. About 50% of men are affected by the age of 50, and between the ages of 70 and 80 the prevalence rises to 70-80%.
There are various surgical procedures available for the treatment of BPH. In this study, we are investigating three surgical procedures which, based on the current data, appear to be relatively equivalent; however, additional data are still needed to substantiate this.
The aim of this study is to compare the three surgical methods REZUM vs. HoLEP vs. TUR-P for endoscopic transurethral subvesical de-obstruction with regard to both subjective and objective voiding function, as well as improvements in quality of life and sexual function.
The goal of the study is to work out the possible advantages and disadvantages for future patient counseling, thereby defining more precisely the role of these surgical procedures within the armamentarium of urology. This is a single-center, randomized, prospective interventional study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TURP | Active comparator | Procedure: Treatment BPH |
| HOLEP | Active comparator | Procedure: Treatment BPH |
| REZUM | Active comparator | Procedure: Treatment BPH |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Patients with confirmed benign prostatic syndrome for whom surgical therapy is indicated
- Prostate volume between 30 and 80 ml
Key exclusion criteria (10 listed)
- Lack of capacity to give informed consent
- Emergency surgeries
- Known prostate carcinoma
- Elevated post-void residual urine > 300 ml
- Neurogenic bladder emptying disorder
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 |
|---|---|---|
| Treatment BPHWe compare 3 different types of BPH surgery - HoLEP vs. TURP vs. REZUM | Procedure or surgery | HOLEP, REZUM, TURP |
Primary outcome
Non-inferiority of the surgical techniques in symptom improvement, determined by the change (delta) in the International Prostate Symptom Score (IPSS) at 1 month compared to baseline IPSS.
Time frame: 1 month
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 19 Nov 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment BPH in people with BPH (Benign Prostatic Hyperplasia) and HoLEP, run by Medical University of Graz.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Conrad Leitsmann, PD Dr. (+43 316 385 81474, conrad.leitsmann@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of the surgical techniques in symptom improvement, determined by the change (delta) in the International Prostate Symptom Score (IPSS) at 1 month compared to baseline IPSS. (time frame: 1 month). 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 19 Nov 2025.