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- Klinische proef NCT04807010
PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia (PROARTE)
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Pooja Doshi
- Telefoonnummer: 580 703-460-5580
- E-mail: pdoshi@sirweb.org
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
• Men ≥45 and ≤90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused.
- International Prostate Symptom Score (I-PSS) score 14 or greater.
- Quality of Life (QoL) score ≥ 3
- Peak urinary flow (Qmax) less than or equal to 12 mL/s with void volume >125mL.
- Prostate volume greater than 30 cc as determined by ultrasound, MRI, or CT.
- Personal risk <40% based on the University of Texas San Antonio prostate cancer risk calculator or having a negative prostate biopsy for cancer within the last 24 months.
- Able to provide written consent.
- Not participating in any other investigational drug or device studies.
Exclusion Criteria:
• History of biopsy-proven prostate cancer
- Renal insufficiency (glomerular filtration rates (GFR) less than 40mL/min/1.73 m2 who are not already on dialysis)
- Prior prostate surgery or intervention, including trans-urethral resection of the prostate, balloon dilation, stent implantation, laser prostatectomy, radiation, UroLift®, or hyperthermia
- Other bladder or urethral pathology requiring therapy, either in the past or currently, including neurogenic bladder, sphincteric abnormalities, bladder cancer, or other causes of bladder atonia.
- Other causes of urinary obstruction, such as strictures of urethra or ureters, not related to BPH
- Current decompensated congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression.
- Neurological disease, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, and previous spinal nerve surgery
- Patients with platelet count <50,000/μL or International Normalized Ratio (INR) >1.8, unless corrected for the procedure
- Active urinary tract infection. Patients must have a negative culture within 7 days of the procedure.
- Allergy to iodinated contrast agents unless pre-treated by corticosteroids.
- Acute urinary retention.
- Post void residual (PVR) > 250 mL with urodynamic evidence of atonic bladder. Patients with a PVR >250 but urodynamic testing consistent with obstruction will be allowed.
- Bladder stone within three months prior to the procedure.
- Hematuria not evaluated by Urologist for causes other than BPH.
- Previous rectal surgery (excluding hemorrhoidectomy) or history of rectal disease.
- Prior pelvic irradiation or radical pelvic surgery.
Imaging exclusion criteria:
• Internal iliac artery occlusion as determined by either CT or MRI.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Sham-vergelijker: Schijnvertoning
|
Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.
Angiogram without embolization initially.
At 6 months patients will be allowed to crossover to prostate artery embolization.
|
Actieve vergelijker: Prostate artery embolization
|
Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
International Prostate Symptom Score
Tijdsspanne: 6 months
|
A survey accessing patient symptomology from BPH induced LUTS
|
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
International Prostate Symptom Score
Tijdsspanne: 1, 3, 6, 9, 12, 24, 36 months
|
A survey accessing patient symptomology from BPH induced LUTS
|
1, 3, 6, 9, 12, 24, 36 months
|
Quality of Life
Tijdsspanne: 1, 3, 6, 9, 12, 24, 36 months
|
A survey accessing quality of life impact on patients from BPH induced LUTS.
|
1, 3, 6, 9, 12, 24, 36 months
|
Maximal urinary flow rate change from baseline
Tijdsspanne: 6, 12, 24, and 36 months
|
Maximal flow rate of urine stream
|
6, 12, 24, and 36 months
|
Post void residual change from baseline
Tijdsspanne: 6, 12, 24, and 36 months
|
Post void residual measures the volume of urine remaining in the bladder after complete emptying.
|
6, 12, 24, and 36 months
|
International Index of Erectile Function questionnaire (IIEF)
Tijdsspanne: 1, 3, 6, 9, 12, 24, 36 months
|
A questionnaire designed to asses erectile function
|
1, 3, 6, 9, 12, 24, 36 months
|
Freedom from secondary intervention to treat BPH
Tijdsspanne: 1, 3, 6, 9, 12, 24, 36 months
|
Recording of other surgical/procedural treatments with each procedure being recorded as an event.
|
1, 3, 6, 9, 12, 24, 36 months
|
Ejaculatory function
Tijdsspanne: 3, 6, 9, 12, 24, 36 months
|
Ejaculatory function will be assessed utilizing a four item questionnaire.
|
3, 6, 9, 12, 24, 36 months
|
Urinary Continence
Tijdsspanne: 1, 6, and 12 months
|
Urinary Continence will be assessed using a 2 item questionnaire
|
1, 6, and 12 months
|
Number of hospital days
Tijdsspanne: 1 month
|
Number of hospital days following the procedure will be recorded
|
1 month
|
Recover experience
Tijdsspanne: 1 month
|
Recover experience will be assessed using a quality of recovery visual analog scale
|
1 month
|
Adverse events
Tijdsspanne: 7 days and 1, 3, 6, 9, 12, 24, 36 months
|
All procedure related adverse events will be recoreded
|
7 days and 1, 3, 6, 9, 12, 24, 36 months
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Shamar Young, MD, University of Minnesota
- Hoofdonderzoeker: Jafar Golzarian, MD, University of Minnesota
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 001 (NavyGHB)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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