Health TrialsbyHealthPanel

Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)

ConditionsTransurethral Resection of Prostate SyndromeProstate HyperplasiaEmbolization, Therapeutic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45+
SponsorUppsala University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

known prostate or bladder cancer

Severe atherosclerosis

Kidney failure eGFR < 30

Urethral stricture

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prostate Artery Embolization

    Procedure/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/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.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: PAEExperimental treatment 1 intervention
Group B: TURPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
24 months
2

Health care costs

Assess the health care costs after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)

Time frame
24 months

Secondary outcomes

1

Adverse effects,

Assess the adverse effects after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)

Time frame
24 months
2

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.

Time frame
24 months
3

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).

Time frame
24 months
4

Prostate-Specific Antigen (PSA)

Assess the change in PSA

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uppsala University

Lead sponsor

Centrallasarettet Västerås

Collaborator

Lasarettet i Enköping

Collaborator

Sormland County Council, Sweden

Collaborator

Region Stockholm

Collaborator

Source ClinicalTrials.gov
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