Minimally Invasive Prostate Interventions Registry (MIST Study)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40+
SponsorNecmettin Erbakan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients aged ≥40 years
Diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS) or benign prostatic obstruction (BPO)
Undergoing a minimally invasive prostate intervention (Rezum, UroLift, Aquablation, PAE, iTind, TPLA, TUNA, TUMT) as part of standard clinical care
Ability and willingness to attend scheduled follow-up visits
Disqualifiers
Active urinary tract infection at the time of treatment
ASA physical status ≥5
Prior pelvic radiotherapy resulting in severe bladder dysfunction
Severe cognitive impairment or inability to participate in follow-up
Trial population
Men aged 40 years and older undergoing minimally invasive prostate interventions for benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS) or benign prostatic obstruction (BPO) across multiple international centers. All treatments are standard-of-care MIST procedures, and participants are followed longitudinally in a single observational registry cohort.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionParticipants receive standard-of-care minimally invasive prostate interventions determined by their treating clinicians. The study does not assign or alter any treatment; it only observes outcomes.
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: MIST_Cohort1 intervention
Trial outcomes
Primary outcomes
1
Change in International Prostate Symptom Score (IPSS)
IPSS is a validated 0-35 questionnaire assessing lower urinary tract symptoms. Lower scores indicate symptom improvement. Change from baseline will be evaluated at each follow-up visit using patient-reported scores collected via standardized REDCap forms.
Time frame
Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure2
Change in maximum urinary flow rate (Qmax)
Qmax (mL/s) is measured by uroflowmetry at each clinical visit. Improvement in urinary flow represents treatment effectiveness. Change from baseline will be analyzed longitudinally.
Time frame
Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure3
Change in quality of life (QoL) score (IPSS subscore)
QoL score ranges from 0-6. Lower scores reflect improved quality of life. Change from baseline is measured using the IPSS-QoL item collected through REDCap.
Time frame
Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedureSecondary outcomes
1
Change in Post-Void Residual (PVR) volume
PVR (mL) measured by ultrasound or bladder scanner. Lower values indicate improved bladder emptying.
Time frame
Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months2
Change in sexual function (IIEF-5 score)
IIEF-5 is a validated 5-item erectile function scale (5-25). Higher scores indicate better sexual function.
Time frame
Baseline; 1, 3, 6, 12, 24, 36, 72 months3
Change in ejaculatory function (MSHQ-EjD score)
MSHQ-EjD evaluates ejaculatory function and bother. Higher function scores indicate improvement.
Time frame
Baseline; 1, 3, 6, 12, 24, 36, 72 months4
Catheterization duration
Duration of urinary catheter use (days) recorded after MIST procedures.
Time frame
Within first 30 postoperative daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Necmettin Erbakan University
Lead sponsor
University Hospital Southampton NHS Foundation Trust
Collaborator
Medical University of Graz
Collaborator
Hannover Medical School
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: