PROEMBO " Prospective , single-center, clinical trial phase - I- II study to evaluate the safety and clinical feasibility and efficacy of arterial Prostataembolisation ( d- PAE ) in patients with moderate to Digital severe symptomatic benign prostatic hyperplasia ( BPH ) "

PROEMBO " Prospective , single-center, clinical trial phase - I- II study to evaluate the safety and clinical feasibility and efficacy of arterial Prostataembolisation ( d- PAE ) in patients with moderate to Digital severe symptomatic benign prostatic hyperplasia ( BPH ) " - PROEMBO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00006308

Enrollment

100

Registered

2016-05-23

Start date

2015-05-12

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N40

Interventions

Group 1: Arterial Prostataembolisation (d-PAE) in patients with moderate to severe symptomatic benign prostatic hyperplasia

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Drug therapierte BPH> 3 months, or Refusal of medical treatment - IPSS =8 with suffering (QoL =3) - The patient wants to date no conventional surgery, or it's been no surgical / anesthetic ability - General status> 70% Karnofsky and ECOG = 1 - Age of the patients = 18 years - Life expectancy = 12 months - Proficiency (understanding) to participate in the study - This written consent of the patient

Exclusion criteria

Exclusion criteria: - Drug therapy Stage 2 (eGFR 100ml in 2 measurements - Uroflow 20ml / sec - Flow profile typical of urethral stricture - Non-feasibility of transrectal ultrasound (TRUS) - Non-feasibility of prostate MRI using an endorectal coil - Patients with a psychiatric disorder or a disorder which may affect the ability to submit a valid declaration to participate in this study - No MRI compatibility (in the opinion of the radiologist) - Contraindication for an angio-CT - Quick =50%; Platelets =50 Gpt / L; PTT> 50 - Bladder stones - Neurogenic bladder dysfunction - Prostatitis - Untreated bladder tumor (transitional cell carcinoma)

Design outcomes

Primary

Measure	Time frame
Security ( Safety ) detected by 1. Clavien - Dindo classification of postoperative complications on days of follow-up visits	—

Secondary

Measure	Time frame
Technical, clinical feasibility and efficacy detected by 1. IPSS ( International Prostate Symptom Score ) 2. FAIT - U ( Functional Assessment of Incontinence Therapy - Urinary ) 3. IIEF - 5 ( International Index of Erectile Function ) 3. pain in my numeric rating scale ( NRS ) , pain diary on days of follow-up visits	—

Countries

Germany

Contacts

Public ContactMax Seidensticker

Klinik und Poliklinik für Radiologie LMU Klinikum der Universität München

Max.Seidensticker@med.uni-muenchen.de089/4400-76642

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026