Comparing two treatments for benign prostatic hyperplasia
Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE): Open Multicentric Randomized Study for Evaluation of Outcomes, Complications, and Health Economics
NA · Uppsala University · NCT05531240
This study is testing whether a new procedure called Prostate Artery Embolization works better than the traditional surgery for treating enlarged prostate symptoms in men.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 45 Years and up |
| Sex | Male |
| Sponsor | Uppsala University (other) |
| Locations | 4 sites (Helsingborg, Region Skånes and 3 other locations) |
| Trial ID | NCT05531240 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Prostate Artery Embolization (PAE) compared to Transurethral Prostate Resection (TURP) in treating benign prostatic hyperplasia, which causes lower urinary tract symptoms. The research focuses on medical outcomes, complications, costs, and perceived quality of life associated with both treatments. Patients will be assessed based on specific criteria, including prostate volume and urinary flow rates, to determine their eligibility for either intervention.
Who should consider this trial
Good fit: Ideal candidates are men with benign prostatic hyperplasia who have not responded to medical treatment and meet specific clinical criteria.
Not a fit: Patients with prostate cancer, severe atherosclerosis, or other significant urinary tract conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a less invasive treatment option that improves their quality of life and reduces healthcare costs.
How similar studies have performed: Other studies have shown promising results for PAE as a treatment for benign prostatic hyperplasia, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Helsingborg, Region Skånes and 3 other locations
- Helsingborgs Hospital — Helsingborg, Region Skånes, Sweden (NOT_YET_RECRUITING)
- Mälarsjukhuset — Eskilstuna, Region Sörmland, Sweden (NOT_YET_RECRUITING)
- Lasarettet i Enköping — Enköping, Region Uppsala, Sweden (NOT_YET_RECRUITING)
- Region Vastmanland Hospital — Västerås, Västmanland, Sweden (RECRUITING)
Study contacts
- Principal investigator: Abbas Chabok — CKF Västerås Uppsala university
- Study coordinator: Emir Majbar, MD
- Email: emir.majbar@regionvastmanland.se
- Phone: +4621173000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Transurethral Resection of Prostate Syndrome, Prostate Hyperplasia, Embolization, Therapeutic, Prostate embolisation, PAE