Benign Prostatic Hyperplasia (BPH)MISTNCT07242807
Minimally Invasive Prostate Interventions Registry (MIST Study)
An observational study of Benign Prostatic Hyperplasia (BPH) and Minimal Invasive Surgery, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH), Minimal Invasive Surgery, LUTS
- How many people
- 2,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2026to 30 Dec 2031
- How long will I take part?
- 72 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Necmettin Erbakan University Medical Faculty Hospital
Konya, 42250
Selim Soytürk, MD, +905077299193, selimsoyturk06@gmail.com
About this study
Official title: Evaluation of Clinical and Functional Outcomes After Minimally Invasive Prostate Interventions: A Multicenter Prospective REDCap Registry (MIST Study)
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.
Read more
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.
Read the 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.
- Being tested
- No intervention
- Keywords
- MIST, Minimally Invasive Surgical Therapy, Rezum, UroLift, Aquablation, Prostatic Artery Embolization, iTind, TPLA, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure
Secondary outcomes (7)
Change in Post-Void Residual (PVR) volume
PVR (mL) measured by ultrasound or bladder scanner. Lower values indicate improved bladder emptying.
Measured: Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months
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.
Measured: Baseline; 1, 3, 6, 12, 24, 36, 72 months
Change in ejaculatory function (MSHQ-EjD score)
MSHQ-EjD evaluates ejaculatory function and bother. Higher function scores indicate improvement.
Measured: Baseline; 1, 3, 6, 12, 24, 36, 72 months
Catheterization duration
Duration of urinary catheter use (days) recorded after MIST procedures.
Measured: Within first 30 postoperative days
Early postoperative complications (Clavien-Dindo classification)
Complications will be categorized using Clavien-Dindo Grade I-V based on standardized definitions.
Measured: Within 30 postoperative days
BICEP bladder injury score
Bladder injury is graded using the validated BICEP classification (0-4b). Applicable only when morcellation or bladder instrumentation is performed.
Measured: During the procedure
Reintervention rate
Need for additional surgery or MIST (TURP, AEEP/HoLEP, repeat MIST, PAE, Aquablation, urethrotomy, implant revisions, etc.).
Measured: Up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start25 Mar 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 72 Months
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust, Medical University of Graz, Hannover Medical School
- Responsible party
- Principal investigator, Selim Soyturk, Necmettin Erbakan University
- Investigators
- Selçuk Güven, MD, PhD, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242807
- Sponsor's protocol ID
- ReScore25-1
- Acronym
- MIST
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be available upon reasonable request for research purposes. Data will be shared following local ethics committee approval and execution of a data-use agreement. No direct patient identifiers will be shared. Data will include demographic variables, baseline assessments, operative details, postoperative outcomes, and follow-up measures collected in the registry.
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.
PubMed 30542055Cornu 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.
PubMed 36964042Huang 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.
PubMed 31727627
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Functional Outcomes After Minimally Invasive Prostate Interventions: A Multicenter Prospective REDCap Registry (MIST Study)
- ClinicalTrials.gov ID
- NCT07242807
- Acronym / sponsor ID
- MIST / ReScore25-1
- Keywords
- MIST, Minimally Invasive Surgical Therapy, Rezum, UroLift, Aquablation, Prostatic Artery Embolization, iTind, TPLA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust, Medical University of Graz, Hannover Medical School
- Study start
- 25 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 72 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIST_Cohort | – | Other: No interventionMen 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No 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. | Other | MIST_Cohort |
Primary outcome
Change in International Prostate Symptom Score (IPSS)
Time frame: 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)
Time frame: 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)
Time frame: 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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 30542055Rukstalis 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.
- Background: PubMed 36964042Cornu 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.
- Background: PubMed 31727627Huang 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be available upon reasonable request for research purposes. Data will be shared following local ethics committee approval and execution of a data-use agreement. No direct patient identifiers will be shared. Data will include demographic variables, baseline assessments, operative details, postoperative outcomes, and follow-up measures collected in the registry.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Selçuk Güven, MD, PhD principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia (BPH) and Minimal Invasive Surgery, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selim Soytürk, MD (+905077299193, selim.soyturk@erbakan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: Baseline; 1, 3, 6, 12, 24, 36, and optional 72 months post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07242807, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.