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Benign Prostatic HyperplasiaNCT02054013

Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia

A study testing Prostatic artery embolization and monopolar transurethral prostatectomy in people with Benign Prostatic Hyperplasia, run by Daniel Stephan Engeler at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years. The clinical picture of the disease includes lower urinary tract symptoms such as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual dysfunction in some individuals. Read more about this study

Who is it for?
Ages 40 years and older, men only
Conditions the study is for
Benign Prostatic Hyperplasia
What is being tested?
Prostatic artery embolization and monopolar transurethral prostatectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteSwitzerland
Study dates
11 Feb 2014to 16 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

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 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men older than 40
  • Patient must be a candidate for TURP
  • Refractory to medical therapy or patient is not willing to consider (further) medical treatment
  • Patient has a prostate size of at least 25 ml and not more than 80 ml, measured by ultrasound
  • IPSS ≥8
  • QoL ≥3
  • Qmax<12 and/or urinary retention
  • Written informed consent

Who cannot join

  • Mild symptoms (IPSS <8)
  • Severe atherosclerosis
  • Severe tortuosity in the aortic bifurcation or internal iliac arteries
  • Acontractile detrusor
  • Neurogenic lower urinary tract dysfunction
  • Urethral stenosis
Show all 12Show fewer
  • Bladder diverticulum
  • Bladder stone with surgical indication
  • Allergy to intravenous contrast media
  • Contraindication for MRI imaging
  • Preinterventionally proven adenocarcinoma of the prostate
  • Renal failure (GFR<60ml/min)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Cantonal Hospital St. Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

Official title: Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Trial

Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years. The clinical picture of the disease includes lower urinary tract symptoms such as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual dysfunction in some individuals. Medical therapy is usually the first-line treatment. However, the efficacy of drugs like alpha-blockers is limited, and as disease progresses more invasive treatment options have to be taken into consideration. In cases with moderate to severe lower urinary tract symptoms (LUTS) transurethral resection of the prostate (TUR-P) is the standard treatment. TURP, however, is limited to prostates smaller than 60-80ml and the procedure is associated with a complication rate. The cumulative short-term morbidity rate is around 11% and the necessity for surgical revision is as high as 6%. Bleeding requiring transfusions and transurethral resection syndrome represent potentially serious threats to elderly and frail patients. Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure, which can be performed in an outpatient setting with rapid recovery and low morbidity.

The investigators hypothesize that PAE is non-inferior in the treatment of symptomatic BPH compared to conventional and established TUR-P.

Being tested
Prostatic artery embolization, monopolar transurethral prostatectomy
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prostatic artery embolizationProcedure or surgery

  • monopolar transurethral prostatectomyProcedure or surgery

Study groups in NCT02054013
Study groupRoleWhat they receive
Prostatic artery embolizationExperimentalProstatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure with rapid recovery and low morbidity
Receives: Procedure: Prostatic artery embolization
Conventional monopolar transurethral prostatectomyOtherStandard treatment
Receives: Procedure: monopolar transurethral prostatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the International Prostate Symptom Score

    Measured: Baseline and 12 weeks after intervention

Secondary outcomes (10)

  1. Changes of prostate volume using Magnetic Resonance Imaging

    Measured: Baseline, 12 weeks and 24 months after intervention

  2. Changes in bladder diary

    Changes in bladder diary (difference of voids during daytime and night-time, difference voided volume, difference liquid intake, difference incontinence episodes)

    Measured: Baseline and at all follow up controls

  3. Pre- and postoperative changes in C-reactive Protein, Prostate-specific antigen (PSA), serum amyloid A, Interleukin-6 and Interleukin-10

    Measured: Baseline and 1 day, 2 days, 1 and 6 weeks post intervention

  4. Changes in urodynamic parameters

    Measured: Baseline and 12 and 24 months after intervention

  5. Duration of hospitalization post procedure

    Measured: hospital discharge

  6. Duration of post procedure catheterization

    Measured: baseline and post intervention

  7. Changes in the CPSI and IIEF

    Measured: baseline and at all follow-up controls after the intervention

  8. Procedure time and radiation parameters

    Measured: after intervention

  9. Comparison of prostate size, measured preoperatively by TRUS and MRI at baseline Comparison of prostate size, measured preoperatively by TRUS and MRI at baseline Comparison of prostate size measured by TRUS and MRI

    Measured: baseline

  10. Percentage of prostate tissue devascularized, based on contrast-enhanced MRI

    Measured: 12 weeks and 24 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2014 (estimated)
  2. Study start11 Feb 2014
  3. Primary completion19 Sep 2017
  4. Study completion16 Jul 2022

Resources

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
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02054013
Sponsor's protocol ID
CTU 13.030
Status last verified
Dec 2022
First submitted
31 Jan 2014
Last updated
7 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Abt D, Mordasini L, Hechelhammer L, Kessler TM, Schmid HP, Engeler DS. Prostatic artery embolization versus conventional TUR-P in the treatment of benign prostatic hyperplasia: protocol for a prospective randomized non-inferiority trial. BMC Urol. 2014 Nov 25;14:94. doi: 10.1186/1471-2490-14-94.

    PubMed 25425136

  • Abt D, Hechelhammer L, Mullhaupt G, Markart S, Gusewell S, Kessler TM, Schmid HP, Engeler DS, Mordasini L. Comparison of prostatic artery embolisation (PAE) versus transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: randomised, open label, non-inferiority trial. BMJ. 2018 Jun 19;361:k2338. doi: 10.1136/bmj.k2338.

    PubMed 29921613

  • Mullhaupt G, Hechelhammer L, Diener PA, Engeler DS, Gusewell S, Schmid HP, Mordasini L, Abt D. Ejaculatory disorders after prostatic artery embolization: a reassessment of two prospective clinical trials. World J Urol. 2020 Oct;38(10):2595-2599. doi: 10.1007/s00345-019-03036-7. Epub 2019 Dec 7.

    PubMed 31813028

  • Mullhaupt G, Hechelhammer L, Engeler DS, Gusewell S, Betschart P, Zumstein V, Kessler TM, Schmid HP, Mordasini L, Abt D. In-hospital cost analysis of prostatic artery embolization compared with transurethral resection of the prostate: post hoc analysis of a randomized controlled trial. BJU Int. 2019 Jun;123(6):1055-1060. doi: 10.1111/bju.14660. Epub 2019 Jan 28.

    PubMed 30578705

  • Abt D, Mullhaupt G, Hechelhammer L, Markart S, Gusewell S, Schmid HP, Mordasini L, Engeler DS. Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia: 2-yr Outcomes of a Randomised, Open-label, Single-centre Trial. Eur Urol. 2021 Jul;80(1):34-42. doi: 10.1016/j.eururo.2021.02.008. Epub 2021 Feb 19.

    PubMed 33612376

  • Mullhaupt G, Hechelhammer L, Graf N, Mordasini L, Schmid HP, Engeler DS, Abt D. Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Obstruction: 5-year Outcomes of a Randomised, Open-label, Noninferiority Trial. Eur Urol Focus. 2024 Sep;10(5):788-795. doi: 10.1016/j.euf.2024.03.001. Epub 2024 Mar 25.

    PubMed 38531756

Questions about this trial

What is this clinical trial studying?

A study testing Prostatic artery embolization and monopolar transurethral prostatectomy in people with Benign Prostatic Hyperplasia, run by Daniel Stephan Engeler at 1 site in Switzerland.

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 8 inclusion and 12 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: finished, as of the sponsor's last update on 7 Dec 2022. 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 Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes in the International Prostate Symptom Score (time frame: Baseline and 12 weeks after intervention). 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 NCT02054013, which also lists 6 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 7 Dec 2022.

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