Minimally Invasive Prostate Interventions Registry (MIST Study)

NCT07242807 | Not Yet Recruiting

• 1 other identifier: ReScore25-1
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia (BPH); Minimal Invasive Surgery; LUTS

Keywords

MIST; Minimally Invasive Surgical Therapy; Rezum; UroLift; Aquablation; Prostatic Artery Embolization; iTind; TPLA; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure

• 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.

  Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure

• 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.

  Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure

Secondary Outcomes (7)

• Change in Post-Void Residual (PVR) volume

  Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months

• Change in sexual function (IIEF-5 score)

  Baseline; 1, 3, 6, 12, 24, 36, 72 months

• Change in ejaculatory function (MSHQ-EjD score)

  Baseline; 1, 3, 6, 12, 24, 36, 72 months

• Catheterization duration

  Within first 30 postoperative days

• Early postoperative complications (Clavien-Dindo classification)

  Within 30 postoperative days

Study Arms (1)

MIST_Cohort

Men aged ≥40 years undergoing minimally invasive prostate interventions (Rezum, Urolift, Aquablation, PAE, iTind, TPLA, TUNA, TUMT) as part of routine clinical care. All participants are observed prospectively in a single registry cohort without assignment to treatment.

Other: No intervention

Interventions

No intervention OTHER

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.

MIST_Cohort

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead
• Medical University of Graz: collaborator
• Hannover Medical School: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator

Study Sites (1)

Necmettin Erbakan University Medical Faculty Hospital

Konya, 42250, Turkey (Türkiye)

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Selçuk Güven, MD, PhD

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selim Soytürk, MD

CONTACT

+905077299193; selim.soyturk@erbakan.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 72 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist / Coordinating Investigator

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: March 25, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2031
• Last Updated: March 31, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data (IPD) and supporting documents will be available beginning 12 months after publication of the primary results manuscript and will remain available for a minimum of 5 years thereafter.
• Access Criteria: Only qualified researchers with a methodologically sound proposal will be granted access. Requests must be reviewed and approved by the principal investigator and require completion of a data-use agreement. Access will be provided in de-identified format only and delivered via secure, password-protected electronic transfer. No direct identifiers or protected health information will be shared.

Locations

TU (1)