Benign Prostatic Hyperplasia (BPH), LUTS, Minimal Invasive Surgery
Conditions
Keywords
MIST, Minimally Invasive Surgical Therapy, Rezum, UroLift, Aquablation, Prostatic Artery Embolization, iTind, TPLA, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Brief 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.
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
OTHERNo 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.
Sponsors
Necmettin Erbakan University
University Hospital Southampton NHS Foundation Trust
Medical University of Graz
Hannover Medical School
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Prostate Symptom Score (IPSS) | Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure | 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. |
| Change in maximum urinary flow rate (Qmax) | Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure | 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. |
| Change in quality of life (QoL) score (IPSS subscore) | Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-Void Residual (PVR) volume | Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months | PVR (mL) measured by ultrasound or bladder scanner. Lower values indicate improved bladder emptying. |
| Change in sexual function (IIEF-5 score) | Baseline; 1, 3, 6, 12, 24, 36, 72 months | IIEF-5 is a validated 5-item erectile function scale (5-25). Higher scores indicate better sexual function. |
| Change in ejaculatory function (MSHQ-EjD score) | Baseline; 1, 3, 6, 12, 24, 36, 72 months | MSHQ-EjD evaluates ejaculatory function and bother. Higher function scores indicate improvement. |
| Catheterization duration | Within first 30 postoperative days | Duration of urinary catheter use (days) recorded after MIST procedures. |
| Early postoperative complications (Clavien-Dindo classification) | Within 30 postoperative days | Complications will be categorized using Clavien-Dindo Grade I-V based on standardized definitions. |
| BICEP bladder injury score | During the procedure | Bladder injury is graded using the validated BICEP classification (0-4b). Applicable only when morcellation or bladder instrumentation is performed. |
| Reintervention rate | Up to 72 months | Need for additional surgery or MIST (TURP, AEEP/HoLEP, repeat MIST, PAE, Aquablation, urethrotomy, implant revisions, etc.). |
Countries
Turkey (Türkiye)
Contacts
CONTACTSelim Soytürk, MD
PRINCIPAL_INVESTIGATORSelçuk Güven, MD, PhD
Necmettin Erbakan University
Outcome results
None listed