Transurethral Resection of Prostate SyndromeNCT05531240
Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)
A study testing Prostate Artery Embolization and Transurethral Prostate Resection (TURP) in people with Transurethral Resection of Prostate Syndrome and Prostate Hyperplasia, run by Uppsala University at 4 sites in Sweden.
Trial summary
This study focuses on the treatment of benign prostatic hyperplasia which causes lower urinary tract symptoms. The purpose of the research project is to evaluate PAE in terms of both medical and health economic outcomes. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Transurethral Resection of Prostate Syndrome, Prostate Hyperplasia, Embolization, Therapeutic
- What is being tested?
- Prostate Artery Embolization and Transurethral Prostate Resection (TURP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 4 sitesSweden
- Study dates
- 1 Oct 2022to Dec 2029
- Phase
- Interventional
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign prostatic hyperplasia where medical treatment has not helped or for other reasons has not been deemed applicable
- IPSS>=12
- Prostate volume [40-100] ml measured via transrectal ultrasound
- Peak flow rate (Qmax) <= 15 ml / s,
- Verified obstruction by urodynamic studies (cystometry)
- Surgery not contraindicated
Who cannot join
- known prostate or bladder cancer
- Severe atherosclerosis
- Kidney failure eGFR < 30
- Urethral stricture
- Active cystitis or prostatitis
- Bladder stone.
- Neurogenic bladder disorder
- known allergy to iodinated contrast medium
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Not yet recruiting
Lasarettet i Enköping
Enköping, Region Uppsala, 745 38
Tammer Hemdan, MD,PhD, +46 17141 80 00
- Not yet recruiting
Mälarsjukhuset
Eskilstuna, Region Sörmland, 633 49
Ninos Oussi, MD, PhD, +46 16103000
- Not yet recruiting
Helsingborgs Hospital
Helsingborg, Region Skånes, 252 23
Mats Bläckberg, MD, PhD, +46 424061000
- Recruiting
Region Vastmanland Hospital
Västerås, Västmanland County, 721 89
Emir Majbar, MD, +46 21173000, emir.majbar@regionvastmanland.se
Farhood Alamdari, MD, PhD, +46 21173000, farhood.alamdari@regionvastmanland.se
About this study
Official title: Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE): Open Multicentric Randomized Study for Evaluation of Outcomes, Complications, and Health Economics
This study focuses on the treatment of benign prostatic hyperplasia which causes lower urinary tract symptoms.
The purpose of the research project is to evaluate PAE in terms of both medical and health economic outcomes. To evaluate whether there are any differences in effect (IPSS), complications, costs and perceived quality of life compared with TUR-P.
- Conditions
- Transurethral Resection of Prostate Syndrome, Prostate Hyperplasia, Embolization, Therapeutic
- Being tested
- Prostate Artery Embolization, Transurethral Prostate Resection (TURP)
- Keywords
- Prostate embolisation, PAE
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Artery EmbolizationProcedure or surgery
Prostate Artery Embolization (PAE) is performed by experienced interventional radiologists. The method involves catheterization of the prostate vessels superselectively with two to three French microcatheters. PAE is performed with microspheres of 250 to 400 µm in size.
Transurethral Prostate Resection (TURP)Procedure or surgery
Under general/regional anesthesia, a resectoscope is inserted into the urethra that carries an electric metal loop (monopolar or bipolar diathermy) that is used to cut and extract the prostate tissue.
| Study group | Role | What they receive |
|---|---|---|
| PAE | Experimental | Prostate Artery Embolization (PAE) Receives: Procedure: Prostate Artery Embolization |
| TURP | Active comparator | Transurethral Prostate Resection (TURP) Receives: Procedure: Transurethral Prostate Resection (TURP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of lower urinary tract symptoms
Assess the change in the lower urinary tract symptoms using the International Prostate Symptom Score (IPSS) questionnaire before and after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)
Measured: 24 months
Health care costs
Assess the health care costs after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)
Measured: 24 months
Secondary outcomes (4)
Adverse effects,
Assess the adverse effects after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)
Measured: 24 months
Quality of life (Short Form Health Survey [EQ-5D-5L ])
Assess the quality of life after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP). Scored 0-100, where 0 is the lowest and 100 the highest possible quality of life.
Measured: 24 months
Erectile function
Erectile function using the International Index of Erectile Function (IIEF-5). The possible scores for the IIEF-5 range from 5 to 25, and ED is classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
Measured: 24 months
Prostate-Specific Antigen (PSA)
Assess the change in PSA
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Oct 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Transurethral Resection of Prostate SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Centrallasarettet Västerås, Lasarettet i Enköping, Sormland County Council, Sweden, Region Stockholm
- Responsible party
- Principal investigator, Abbas Chabok MD, Uppsala University
- Investigators
- Abbas Chabok, Principal investigator, CKF Västerås Uppsala university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531240
- Sponsor's protocol ID
- 276725
- Status last verified
- Sep 2026
- First submitted
- 30 May 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991 Aug 24;338(8765):469-71. doi: 10.1016/0140-6736(91)90543-x.
PubMed 1714529Hunter DJ, McKee M, Black NA, Sanderson CF. Health status and quality of life of British men with lower urinary tract symptoms: results from the SF-36. Urology. 1995 Jun;45(6):962-71. doi: 10.1016/s0090-4295(99)80116-2.
PubMed 7539561Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
PubMed 1279218Young S, Golzarian J. Prostate embolization: patient selection, clinical management and results. CVIR Endovasc. 2019 Jan 18;2(1):7. doi: 10.1186/s42155-019-0049-1.
PubMed 32027007Carnevale FC, Antunes AA, da Motta Leal Filho JM, de Oliveira Cerri LM, Baroni RH, Marcelino AS, Freire GC, Moreira AM, Srougi M, Cerri GG. Prostatic artery embolization as a primary treatment for benign prostatic hyperplasia: preliminary results in two patients. Cardiovasc Intervent Radiol. 2010 Apr;33(2):355-61. doi: 10.1007/s00270-009-9727-z. Epub 2009 Nov 12.
PubMed 19908092
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE): Open Multicentric Randomized Study for Evaluation of Outcomes, Complications, and Health Economics
- ClinicalTrials.gov ID
- NCT05531240
- Acronym / sponsor ID
- 276725
- Conditions
- Transurethral Resection of Prostate Syndrome, Prostate Hyperplasia, Embolization, Therapeutic
- Keywords
- Prostate embolisation, PAE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Centrallasarettet Västerås, Lasarettet i Enköping, Sormland County Council, Sweden, Region Stockholm
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 7 Sep 2022 (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 study focuses on the treatment of benign prostatic hyperplasia which causes lower urinary tract symptoms.
The purpose of the research project is to evaluate PAE in terms of both medical and health economic outcomes. To evaluate whether there are any differences in effect (IPSS), complications, costs and perceived quality of life compared with TUR-P.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAE | Experimental | Procedure: Prostate Artery EmbolizationProstate Artery Embolization (PAE) |
| TURP | Active comparator | Procedure: Transurethral Prostate Resection (TURP)Transurethral Prostate Resection (TURP) |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Benign prostatic hyperplasia where medical treatment has not helped or for other reasons has not been deemed applicable
- IPSS>=12
- Prostate volume [40-100] ml measured via transrectal ultrasound
- Peak flow rate (Qmax) <= 15 ml / s,
- Verified obstruction by urodynamic studies (cystometry)
Key exclusion criteria (8 listed)
- known prostate or bladder cancer
- Severe atherosclerosis
- Kidney failure eGFR < 30
- Urethral stricture
- Active cystitis or prostatitis
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 |
|---|---|---|
| Prostate Artery EmbolizationProstate Artery Embolization (PAE) is performed by experienced interventional radiologists. The method involves catheterization of the prostate vessels superselectively with two to three French microcatheters. PAE is performed with microspheres of 250 to 400 µm in size. | Procedure or surgery | PAE |
| Transurethral Prostate Resection (TURP)Under general/regional anesthesia, a resectoscope is inserted into the urethra that carries an electric metal loop (monopolar or bipolar diathermy) that is used to cut and extract the prostate tissue. | Procedure or surgery | TURP |
Primary outcome
Improvement of lower urinary tract symptoms
Time frame: 24 months
Assess the change in the lower urinary tract symptoms using the International Prostate Symptom Score (IPSS) questionnaire before and after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)
Health care costs
Time frame: 24 months
Assess the health care costs after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)
4 secondary outcomes
Adverse effects,
Time frame: 24 months
Quality of life (Short Form Health Survey [EQ-5D-5L ])
Time frame: 24 months
Erectile function
Time frame: 24 months
Prostate-Specific Antigen (PSA)
Time frame: 24 months
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 2 Oct 2026.
- Background: PubMed 1714529Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991 Aug 24;338(8765):469-71. doi: 10.1016/0140-6736(91)90543-x.
- Background: PubMed 7539561Hunter DJ, McKee M, Black NA, Sanderson CF. Health status and quality of life of British men with lower urinary tract symptoms: results from the SF-36. Urology. 1995 Jun;45(6):962-71. doi: 10.1016/s0090-4295(99)80116-2.
- Background: PubMed 1279218Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
- Background: PubMed 32027007Young S, Golzarian J. Prostate embolization: patient selection, clinical management and results. CVIR Endovasc. 2019 Jan 18;2(1):7. doi: 10.1186/s42155-019-0049-1.
- Background: PubMed 19908092Carnevale FC, Antunes AA, da Motta Leal Filho JM, de Oliveira Cerri LM, Baroni RH, Marcelino AS, Freire GC, Moreira AM, Srougi M, Cerri GG. Prostatic artery embolization as a primary treatment for benign prostatic hyperplasia: preliminary results in two patients. Cardiovasc Intervent Radiol. 2010 Apr;33(2):355-61. doi: 10.1007/s00270-009-9727-z. Epub 2009 Nov 12.
- Guidelines on Management of Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS), incl. Benign Prostatic Obstruction (BPO) 2021. I: European Association of Urology Guidelines 2021 EditionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Abbas Chabok principal investigator
CKF Västerås Uppsala university
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate Artery Embolization and Transurethral Prostate Resection (TURP) in people with Transurethral Resection of Prostate Syndrome and Prostate Hyperplasia, run by Uppsala University at 4 sites in Sweden.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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?
Contact Emir Majbar, MD (+46-021176939, emir.majbar@regionvastmanland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of lower urinary tract symptoms (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05531240, which also lists 5 linked publications.
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 2 Oct 2026.