Minimally Invasive Prostate Interventions Registry (MIST Study)

Official title

Evaluation of Clinical and Functional Outcomes After Minimally Invasive Prostate Interventions: A Multicenter Prospective REDCap Registry (MIST Study)

Overview

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.

Detailed description

Benign prostatic obstruction (BPO) secondary to benign prostatic hyperplasia (BPH) is a prevalent cause of lower urinary tract symptoms (LUTS) in aging men. Minimally invasive surgical therapies (MIST) have become increasingly utilized due to their favorable safety profiles, reduced hospitalization times, preservation of sexual function, and quicker return to normal activities. Despite their growing use, comparative real-world data across MIST modalities remain limited, especially regarding long-term functional outcomes and retreatment rates.

The MIST Registry is an investigator-initiated, non-commercial, multicenter, observational cohort study coordinated by the Department of Urology at Necmettin Erbakan University. The aim is to systematically collect high-quality clinical data from centers using a standardized REDCap electronic data capture system. The registry includes patients treated with any guideline-supported minimally invasive prostate intervention, including Rezum, UroLift, Aquablation, prostatic artery embolization (PAE), iTind, TPLA, TUNA, and TUMT. These procedures are performed as part of routine clinical care and not assigned by the study.

Data collection includes demographics, comorbidities, prior BPO treatments, LUTS medication history, PSA levels, prostate volume, presence and size of median lobe, uroflowmetry parameters, PVR, patient-reported outcomes (IPSS, QoL, IIEF-5, MSHQ-EjD), and urodynamic findings when available. Intraoperative data include type of MIST technique, procedure duration, device usage, energy delivery parameters, imaging guidance, estimated blood loss, and intraoperative complications. Postoperative outcomes include catheterization duration, early complications within 30 days, rehospitalization, urinary retention, infections, and device-related events. Complications are categorized according to the Clavien-Dindo classification, and bladder injury can be scored using the BICEP system where relevant.

Follow-up assessments occur at 1, 3, 6, 12, 24, and 36 months, with optional long-term evaluations at 72 months. Outcomes assessed include symptom scores, Qmax, PVR, PSA, medication changes, and any surgical or minimally invasive reinterventions. Statistical analyses will include descriptive summaries, longitudinal comparisons, multivariable modeling to identify predictors of success or failure, and Kaplan-Meier estimates of reintervention-free survival.

The registry is designed to generate real-world evidence that reflects routine clinical practice across diverse populations and healthcare systems. Findings are expected to inform patient selection, refine procedural decision-making, improve counseling on expected outcomes, and support comparative effectiveness research among emerging minimally invasive prostate treatments.

Interventions

• Other No intervention
  Participants 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.

Primary outcome measures

• Change in International Prostate Symptom Score (IPSS) [Time frame: Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure]
• Change in maximum urinary flow rate (Qmax) [Time frame: Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure]
• Change in quality of life (QoL) score (IPSS subscore) [Time frame: Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure]

Secondary outcome measures (7)

• Change in Post-Void Residual (PVR) volume [Time frame: Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months]
• Change in sexual function (IIEF-5 score) [Time frame: Baseline; 1, 3, 6, 12, 24, 36, 72 months]
• Change in ejaculatory function (MSHQ-EjD score) [Time frame: Baseline; 1, 3, 6, 12, 24, 36, 72 months]
• Catheterization duration [Time frame: Within first 30 postoperative days]
• Early postoperative complications (Clavien-Dindo classification) [Time frame: Within 30 postoperative days]
• BICEP bladder injury score [Time frame: During the procedure]
• Reintervention rate [Time frame: Up to 72 months]

Eligibility criteria

Inclusion criteria

• 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
• Prospective participants able to provide written informed consent
• Retrospective cases eligible if data are fully de-identified and inclusion is approved by local ethics/IRB authorities

Exclusion criteria

• 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
• Missing essential baseline data (for retrospective entries)
• Patients receiving experimental or investigational prostate devices or therapies outside routine clinical care

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 1 center

• Necmettin Erbakan University Medical Faculty Hospital — Konya

Publications

• Rukstalis D, Grier D, Stroup SP, Tutrone R, deSouza E, Freedman S, David R, Kamientsky J, Eure G. Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study. Prostate Cancer Prostatic Dis. 2019 Sep;22(3):411-419. doi: 10.1038/s41391-018-0118-x. Epub 2018 Dec 12. PMID 30542055
• Cornu JN, Zantek P, Burtt G, Martin C, Martin A, Springate C, Chughtai B. Minimally Invasive Treatments for Benign Prostatic Obstruction: A Systematic Review and Network Meta-analysis. Eur Urol. 2023 Jun;83(6):534-547. doi: 10.1016/j.eururo.2023.02.028. Epub 2023 Mar 22. PMID 36964042
• Huang SW, Tsai CY, Tseng CS, Shih MC, Yeh YC, Chien KL, Pu YS, Tu YK. Comparative efficacy and safety of new surgical treatments for benign prostatic hyperplasia: systematic review and network meta-analysis. BMJ. 2019 Nov 14;367:l5919. doi: 10.1136/bmj.l5919. PMID 31727627

Identifiers

NCT: NCT07242807 · ReScore25-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗