Clinical Trial

Minimally Invasive Prostate Interventions Registry (MIST Study)

Study acronym: MIST
Not Yet Recruiting
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Summary
This study is a multicenter prospective patient registry designed to evaluate clinical, functional, and safety outcomes after minimally invasive prostate interventions (MIST) performed for benign prostatic obstruction (BPO) secondary to benign prostatic hyperplasia (BPH). The interventions included in this registry represent standard-of-care treatment options and may include Rezum water vapor therapy, UroLift prostatic urethral lift, Aquablation, prostatic artery embolization (PAE), iTind, transperineal laser ablation (TPLA), transurethral needle ablation (TUNA), and transurethral microwave therapy (TUMT). The registry collects standardized data using a secure REDCap platform from participating international centers. Data elements include demographic characteristics, comorbidities, medication use, laboratory parameters, prostate volume assessments, uroflowmetry, post-void residual measurements, patient-reported symptom scores, sexual function assessments, intraoperative details, complications (classified using Clavien-Dindo), and postoperative recovery parameters. Follow-up visits occur at 1, 3, 6, 12, 24, and 36 months, with an optional extended follow-up at 72 months to assess long-term durability and reintervention-free survival. The primary aim of the study is to evaluate improvements in urinary symptoms (IPSS), quality of life, maximum urinary flow rate (Qmax), and post-void residual volume (PVR) following MIST procedures. Secondary objectives include assessing perioperative safety, catheterization duration, predictors of treatment success or failure, need for reintervention, and long-term preservation of continence and sexual function. This registry is observational and does not assign or modify any treatment. All procedures are performed based on local clinical practice and physician judgment. Prospective participants provide informed consent. Data collected will be used to generate real-world evidence to guide patient selection, optimize procedural outcomes, and compare clinical performance across different minimally invasive prostate interventions.
Protocol Amendment History 1 change
minor Completion pushed: 2030-12-30 -> 2031-12-30 2026-04-01
Trial Details
NCT Number NCT07242807
Lead Sponsor Necmettin Erbakan University
Collaborators: University Hospital Southampton NHS Foundation Trust, Medical University of Graz, Hannover Medical School
Conditions Benign Prostatic Hyperplasia (BPH), Minimal Invasive Surgery, LUTS
Enrollment 2,000 participants
Start Date 2026-03-25
Primary Completion 2028-12-30 (estimated)
Study Completion 2031-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-31