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

Not Applicable

Recruiting

• Conditions: Transurethral Resection of Prostate Syndrome; Embolization, Therapeutic; Prostate Hyperplasia

• Registration Number: NCT05531240
• Lead Sponsor: Uppsala University

Brief 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. To evaluate whether there are any differences in effect (IPSS), complications, costs and perceived quality of life compared with TUR-P.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-30
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-05
• Study First Posted: 2022-09-07
• Last Update Submitted: 2022-09-30
• Study Start: 2022-10
• Last Update Posted: 2022-10-03
• Primary Completion: 2023-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 104

Inclusion Criteria

• Benign prostatic hyperplasia where medical treatment has not helped or for other reasons has not been deemed applicable
• IPSS>=8
• Prostate volume [40-80] ml measured via transrectal ultrasound
• Peak flow rate (Qmax) <= 15 ml / s,
• Verified obstruction by urodynamic studies (cystometry)
• Surgery not contraindicated

Exclusion Criteria

• Prostate cancer
• Severe atherosclerosis
• Kidney failure
• Urethral stricture
• Active cystitis or prostatitis
• Bladder stone.
• Neurogenic bladder disorder
• Contrast product allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement of lower urinary tract symptoms	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	24 months	Assess the health care costs after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)

Secondary Outcome Measures

Name	Time	Method
Quality of life (Short Form Health Survey [EQ-5D-5L ])	24 months	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.
Prostate-Specific Antigen (PSA)	24 months	Assess the change in PSA
Erectile function	24 months	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).
Adverse effects,	24 months	Assess the adverse effects after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)

Trial Locations

Locations (4)

Helsingborgs Hospital; 🇸🇪 Helsingborg, Region Skånes, Sweden

Mälarsjukhuset; 🇸🇪 Eskilstuna, Region Sörmland, Sweden

Lasarettet i Enköping; 🇸🇪 Enköping, Region Uppsala, Sweden

Region Vastmanland Hospital; 🇸🇪 Västerås, Västmanland, Sweden