First Multi-Center, Real-World Study on the Temporary Implantable Nitinol Device (iTIND) for the Management of Lower Urinary Tract Symptoms Related to Benign Prostatic Obstruction

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The study addresses a timely topic in urology—minimally invasive surgical therapies (MIST)—which continue to generate growing clinical interest. After reading it with interest, I would like to raise several points:

• It is noted that all patients underwent cystoscopy prior to the procedure. Was this solely to assess for the presence of a middle lobe, or were there additional diagnostic purposes? Clarifying this would be helpful.

• Were the procedures performed under sedation or local anesthesia? This is particularly relevant in the context of MIST, as the anesthetic approach significantly influences the procedure's invasiveness and patient recovery.

• Your inclusion criteria for prostate volume were 20–70 mL, but the median and interquartile range reported in the results (30 [26–38] mL) are much lower. There is a notion that iTind tends to be more effective in smaller prostates. Do you share this view? Reporting a maximum inclusion volume of 70 mL while the actual population consisted mostly of prostates under 40 mL may be misleading for urologists interested in initiating iTind treatments. It would be appropriate to acknowledge this as a limitation of the study.

• Line 168: Table 2 is referenced, but the data it presents is not discussed in the corresponding text. Please address this oversight.

• The conclusion reads more as a general introduction to the iTind device than as a summary of the study’s findings. I recommend revising it to better reflect the specific observations and outcomes reported in the current study.

Author Response

Comment 1

It is noted that all patients underwent cystoscopy prior to the procedure. Was this solely to assess for the presence of a middle lobe, or were there additional diagnostic purposes? Clarifying this would be helpful.

We thank the reviewer. The adoption of a preop cystoscopy is intended to exlcude urethral stricture, assess the morphology of the prostate, check for bladder health, and also to test the patient tolerance for a possible procedure in local anaesthesia.

Comment 2

Were the procedures performed under sedation or local anesthesia? This is particularly relevant in the context of MIST, as the anesthetic approach significantly influences the procedure's invasiveness and patient recovery.

Thank you for this comment. We added a sentence in the new version. 

Comment 3

Your inclusion criteria for prostate volume were 20–70 mL, but the median and interquartile range reported in the results (30 [26–38] mL) are much lower. There is a notion that iTind tends to be more effective in smaller prostates. Do you share this view? Reporting a maximum inclusion volume of 70 mL while the actual population consisted mostly of prostates under 40 mL may be misleading for urologists interested in initiating iTind treatments. It would be appropriate to acknowledge this as a limitation of the study.

I would say thank you very much for raising this question. When you submit a protocol or define a group in a clinical study, usually, you try to stay wide enough to include a sample representative of the disease you need to cure. In this field, as you said, even if we left free to include all the urologist patients untile 70cc of prostate volume, quite homogeneously all urologists (across several internationally reputeed centers) treated and enrolled patients with the same characteristics : small prostates with high bladder neck, without median lobe . Personally I don't think this is a limitation of the study, this is a limitation of the indications spread by the manufacturer!   

Comment 4 

Line 168: Table 2 is referenced, but the data it presents is not discussed in the corresponding text. Please address this oversight.

Thank you very much, it was an error to report for the second time (Table 2) at the end of the sentence. We correct the draft.

Comment 5

The conclusion reads more as a general introduction to the iTind device than as a summary of the study’s findings. I recommend revising it to better reflect the specific observations and outcomes reported in the current study.

We thank the reviewer, we changed the whole conclusion section. 

Reviewer 2 Report

Comments and Suggestions for Authors

Thank you  for the opportunity to revise this manuscript titled: First multi-center, real-world study on the temporary implantable nitinol device (iTind) for the management of lower urinary tract symptoms related to benign prostatic obstruction. Few points need to be considered.

• This a multi-center study that represents real world practice using i Tind however, it is retrospective with small number of patients, and these has to be added to the limitations.
• The results section including important subjective and objective data that it is important to the reader. But the question is: were patients excluded based on preoperative PVR?
• For patients who had immediate post operative retention and catheter has to be used, was there any disturbance happened to the iTind?
• I appreciate that the authors well explained that iTind is a bridge therapy, but the discussion may improve by explaining why some patients would not respond well to i Tind.
• There are several grammatical errors, I believe that manuscript will benefit from English editing. please change the number formatting from comma to period for example (9,4% to 9.4%)
• What is the main question addressed by the research?

Is iTind safe and effective for BPH management in <80 cc prostate size in a real world setting and what is the retreatment rate.

• 2 Do you consider the topic original or relevant to the field? Does it address a specific gap in the field? The topic is very relevant as it represents a real world practice after RCT study has been previously done. It will help in counselling the patients and urology community about the use of i Tind in a select group of patients with the advantage of preservation of sexual function.
• What does it add to the subject area compared with other published material?

It will reinforce the previous data related to i Tind in terms of tolerability and adverse events plus retreatment rate incidence.

• What specific improvements should the authors consider regarding the methodology? It was already mentioned in the limitation that it is lacking control group and longer follow up data. I believe this work should benefit from a multivariate analysis to identify predictors of failure.
• Are the conclusions consistent with the evidence and arguments presented and do they address the main question posed? I believe the conclusion support the data that i Tind has good short-term results with advantage of preservation of sexual function. However, I believe the word significant advancement should be removed as we are still lacking comparative studies and longer follow up.
• All references are appropriate and no additional comments on tables or figures.

 

 

Author Response

Comment 1 

This a multi-center study that represents real world practice using i Tind however, it is retrospective with small number of patients, and these has to be added to the limitations.

Thank for this comment we modified the draft.

Comment 2

The results section including important subjective and objective data that it is important to the reader. But the question is: were patients excluded based on preoperative PVR?

Thank for this comment ! Thi s is a real life study that mirrors the clinical practice. No exclusion have been done based on PVR (the data about mean PVR values are showed).

Comment 3

For patients who had immediate post operative retention and catheter has to be used, was there any disturbance happened to the iTind?

We added a comment on that on the manuscript. Thank you very much.

Comment 4

I appreciate that the authors well explained that iTind is a bridge therapy, but the discussion may improve by explaining why some patients would not respond well to i Tind.

 

Comment 5

There are several grammatical errors, I believe that manuscript will benefit from English editing. please change the number formatting from comma to period for example (9,4% to 9.4%)

Thank you very much. 

Comment 6

It was already mentioned in the limitation that it is lacking control group and longer follow up data. I believe this work should benefit from a multivariate analysis to identify predictors of failure.

We added a comment on that on the manuscript. Thank you very much.

Comment 7 

I believe the conclusion support the data that i Tind has good short-term results with advantage of preservation of sexual function. However, I believe the word significant advancement should be removed as we are still lacking comparative studies and longer follow up.

We modified the conclusion as suggested.

Reviewer 3 Report

Comments and Suggestions for Authors

The authors have submitted a manuscript entitled "First Multi-Center, Real-World Study on the Temporary Implantable Nitinol Device (iTind) for the Management of Lower Urinary Tract Symptoms Related to Benign Prostatic Obstruction".

It is a retrospective "real world" study without a control group. nevertheless, it is of some value.

It should be reported whether the patients received a medical drug therapy before the implanatation of the nitinol stent and if yes, was it the same in all patients included in the study.

The figures reported for  PVR in the Abstract (from 75 ml at baseline to 0 ml at the last follow-up) are not consistent with those shown in table 2 ( from 56 ml at baseline to 40 ml at the last follow-up). Which figures are correct?

Author Response

Comment 1

It should be reported whether the patients received a medical drug therapy before the implantation of the nitinol stent and if yes, was it the same in all patients included in the study.

Thank you for this criticiscm. Being a real life study we cannot change the routine practice of treating physicians. So, as happens in all the cases of patients with small prostate and obstruction, a challenge with alphablocker has been administered in about 39% of patients. 

Comment 2

The figures reported for  PVR in the Abstract (from 75 ml at baseline to 0 ml at the last follow-up) are not consistent with those shown in table 2 ( from 56 ml at baseline to 40 ml at the last follow-up). Which figures are correct? 

This is a typo coming for another abstract... tha correct are from 56 ml at baseline to 40 ml at the last follow-up. The manuscript has been improved as suggested.

Reviewer 4 Report

Comments and Suggestions for Authors

This is a small retrospective study about management of BPH patients with the iTint device. The study is well written and the outcomes are well supported nevertheless I have some remarks

1)Literature already has several prospective studies, an RCT and a meta analysis about this subject. So in order to consider a retrospective study eligible for publication it must have enough strength and robust outcomes. This study is a retrospective study with all the inherited limitations, it has small number of patients and it is multicenter that in my point of view is a disadvantage for this kind of paper since there is no standardized protocol for the patients. In other words the basic factors that could provide strength to the study are not present

2)The paper has no control group. We cannot rely on conclusions of a retrospective study that does not provide a basic comparison with a standard of care procedure (conservative or invasive) 

3)In outcomes we see that even though IIEF and also Qmax at 12 months have a limited change the p values are not significant. Is there an error here or else authors must expand on this

4)Authors make a comment about retreatment of patient. Please expand on the reasons of this decision. We must consider this as a failure of the iTINT or there was some other reason?

5)Since there is no control group it would be a good idea to compare the outcomes of this study to the existing knowledge but not only from papers for iTINT but also we papers with more standard procedures. 

Author Response

Comment 1

Literature already has several prospective studies, an RCT and a meta analysis about this subject. So in order to consider a retrospective study eligible for publication it must have enough strength and robust outcomes. This study is a retrospective study with all the inherited limitations, it has small number of patients and it is multicenter that in my point of view is a disadvantage for this kind of paper since there is no standardized protocol for the patients. In other words the basic factors that could provide strength to the study are not present.

We agree with this point of view. Real-life studies reflect routine clinical practice, patient diversity, and real-world conditions, making the results more applicable to everyday settings, whereas RCTs often have strict inclusion/exclusion criteria that limit generalizability.

 

Real-life studies are generally less resource-intensive and without support or sponsorship it is difficult realize RCT, that sometimes have produces "marketing-oriented results".

Comment  2

The paper has no control group. We cannot rely on conclusions of a retrospective study that does not provide a basic comparison with a standard of care procedure (conservative or invasive) 

Comment 3

In outcomes we see that even though IIEF and also Qmax at 12 months have a limited change the p values are not significant. Is there an error here or else authors must expand on this

Comment 4

Authors make a comment about retreatment of patient. Please expand on the reasons of this decision. We must consider this as a failure of the iTINT or there was some other reason?

Comment 5

Since there is no control group it would be a good idea to compare the outcomes of this study to the existing knowledge but not only from papers for iTINT but also we papers with more standard procedures. 

Thank you for the suggestion. We fully acknowledge the absence of a control group as a limitation inherent to the real-life study design in the "limitations section". However, this was a deliberate methodological choice to prioritize external validity and reflect outcomes in routine clinical practice, without sponsor. To address the lack of direct comparison, we agree that contextualizing our findings against the existing literature—including not only studies on iTind but also those evaluating standard procedures (e.g., TURP, Urolift, Rezūm)—is essential.