When the Evidence Is Sponsored: What a New Systematic Review Tells Us About MIST Data and the Guidelines Built on It

#MISTAudit

Most debates about minimally invasive surgical therapies (MISTs) for benign prostatic hyperplasia argue over numbers — reintervention at five years, ejaculatory preservation, symptom scores. A 2025 systematic review in World Journal of Urology by Akgul and colleagues does something more uncomfortable. It argues about where the numbers come from. And its finding is one the field has been reluctant to state plainly: the evidence base underpinning several MISTs is structurally compromised by industry sponsorship, to a degree that should change how cautiously we read it — and how cautiously guidelines should borrow from it.

This is not a fringe critique. The author list includes Thomas Herrmann, Christopher Netsch and Jens Rassweiler — senior figures in European endourology, not outsiders with a grudge. And notably, the review itself declares no industry funding and no competing interests. An audit of sponsorship that is itself unsponsored carries a particular kind of weight.

The headline numbers

Across 99 studies and 12,230 patients, the authors applied a structured conflict-of-interest framework assessing funding, sponsor influence and objectivity. The result: funding was rated high-risk in 65% of studies, direct sponsor influence was evident in 52%, and only 18% of studies were low-risk across all criteria. The remainder sat in the moderate band.

Take that in. In fewer than one in five studies could the authors find independent funding, minimal sponsor involvement and unbiased reporting together. For a literature that feeds directly into clinical recommendations and patient counselling, that is not a footnote. It is the headline.

The picture by technology

The aggregate figure is striking, but the per-technology breakdown is where the review becomes difficult to wave away, because these are simply the paper's own counts.

For Aquablation, 9 of the 11 included studies were rated high-risk for funding, and only one was independently funded. For Prostatic Urethral Lift, the majority of the studies were conducted by NeoTract, with 13 rated high-risk. For Water Vapour Thermal Therapy, 10 of the studies were high-risk, dominated by Boston Scientific and NxThera. By contrast, prostatic artery embolisation and iTIND — the technologies with the least commercial champion behind them — were predominantly independently funded and carried the lowest COI risk.

There is an obvious objection to anticipate here, and it is worth meeting head-on rather than hiding from. The same review reports that Aquablation has among the lowest reintervention rates of any MIST — roughly 4.4% to 6% at five years, more favourable than WVTT or PUL. Doesn't that vindicate the technology regardless of who paid for the studies?

It would, if those favourable durability figures came from somewhere other than the very studies the review flags. But they don't. The reintervention data most often cited for Aquablation derive overwhelmingly from the PROCEPT-funded WATER and WATER II programmes — precisely the high-risk studies in this matrix. The favourable profile and the sponsorship are not two separate facts to be weighed against each other; they are the same fact seen from two sides. A reassuring number produced inside a sponsored trial with narrow entry criteria is exactly the kind of number this review is asking us to handle with care.

The mechanism that should worry guideline panels

The deeper contribution of the paper is not the COI tally — it is the description of how the bias operates, which is more subtle than overt data manipulation.

Industry-initiated studies, the authors note, tend to apply narrowly tailored inclusion and exclusion criteria. Carefully selected patients — the right prostate size, the right anatomy, no awkward comorbidities — yield clean, favourable results. Those results then get presented, and read, as if they describe the broad real-world population a urologist actually treats. The broad-inclusion studies that would test whether the findings generalise are, in the authors' words, still awaited. In the meantime, the favourable narrow-population data flow upward into systematic reviews and, from there, into guideline recommendations.

That is the chain the review asks us to look at honestly: restrictive entry criteria, favourable output, extrapolation beyond the population studied, and finally codification in guidance. Each link looks reasonable in isolation. The aggregate is a recommendation resting on evidence that was never designed to support it.

The authors are explicit about the implication. Extrapolating these findings into clinical guidelines, they write, can be problematic given the potential conflicts of interest — and priority should go to long-term studies with independent funding. This is not anti-MIST. It is anti-credulity.

This is a literature-wide problem, not a single-device scandal

It would be a misreading to take this paper as an indictment of any one technology. Aquablation, WVTT and Optilume all show genuinely favourable long-term reintervention outcomes in the review; the authors say so directly. The point is not that these procedures don't work. It is that our confidence in how well they work, and for whom, is calibrated against a body of evidence that 65% of the time was funded by the party with the most to gain — and that this should be made visible rather than quietly absorbed.

A supporting study the review cites makes the human side of this concrete: Singh and colleagues found that authors receiving industry payments published more positively on UroLift and Rezum, and that 80% of them did not declare the conflict. The influence is not hypothetical, and it is not always disclosed.

Where this leaves the audit

The constructive conclusion Akgul and colleagues reach is the right one, and it is one this series has argued for repeatedly: structured COI assessment should be built into the systematic reviews that feed guidelines, not treated as an optional disclosure line at the end. If a recommendation rests largely on high-risk, sponsor-influenced, narrow-inclusion evidence, that fact belongs in the strength-of-recommendation reasoning — not buried in a supplementary table.

We don't need fewer MISTs. We need evidence that earns the confidence we place in it, and guidelines honest about the difference between what was demonstrated and what was extrapolated. A systematic review written by senior urologists, with no industry money behind it, telling us that more than half their own field's evidence shows sponsor influence, is about as clear a signal as the literature is going to send.

The numbers we argue over are only as good as the studies that produced them. This paper is a reminder to keep asking who paid for the study before we quote the result.

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Akgul B, Tozsin A, Aydın A, et al. Reintervention rates after minimally invasive benign prostatic hyperplasia therapies: a systematic review including industry involvement. World J Urol 2025;43:494. doi:10.1007/s00345-025-05884-y — PubMed

The 2026 SIU-ICUD Consultation on Male LUTS: A Structural Conflict of Interest Analysis

Fernando Gómez Sancha · ICUA Madrid · March 2026

In March 2026, the Société Internationale d'Urologie published the SIU-ICUD Consultation on Individualized Management of Male LUTS, edited by Dean Elterman, Stavros Gravas, and Andrea Tubaro ^[1]. At 420 pages, with seven committees and contributors from across the world, it is a serious and comprehensive document that will serve as a reference for urologists worldwide. I read it carefully, and I believe it deserves an equally careful critical reading.

Full disclosure: I have performed over 10,000 holmium laser enucleations of the prostate (HoLEP). I have trained more than 600 urologists in this technique across 60 countries, and that training generates direct professional income. I published the technique of en-bloc HoLEP with early apical release in 2019 ^[9], subsequently studied in a global multicenter registry of 6,193 patients ^[2]. I have received speaking fees and proctoring arrangements from Quanta System, Richard Wolf, and Andromeda Surgical — manufacturers of HoLEP equipment. I receive no payment from any manufacturer of devices discussed in this article, but I have a direct professional and commercial interest in the wider adoption of HoLEP. Any reader should weigh my perspective with this in mind.

I am not a neutral observer. Neither, as I will argue with specific evidence, is this document.

I. The Declared Sponsors and the Conflict Architecture

The document's copyright page states: "The SIU-ICUD Committee would like to acknowledge the support of the following partners: Boston Scientific, GSK, Laborie, Pierre Fabre Laboratoires, PROCEPT BioRobotics, and Teleflex." ^{[1, p. 2]}

The alignment between each sponsor and its covered technology is exact:

• Boston Scientific → Rezūm water vapor thermal therapy (dedicated chapter, procedural video)
• Teleflex (NeoTract) → UroLift prostatic urethral lift (dedicated chapter)
• PROCEPT BioRobotics → Aquablation / HYDROS system (dedicated chapter, 4 corporate images, procedural video)
• GSK → Dutasteride (Avodart/Duodart), covered in the pharmacological management chapter

Every sponsor's product appears in the clinical recommendations. This alignment is not a coincidence to be acknowledged and set aside — it is the structural condition under which the document was produced.

What follows is more specific than a general concern about industry funding.

II. The Named Positions: A Structural Analysis

The 2026 SIU-ICUD Consultation does not include a declarations-of-interest section for any committee member. In a 420-page document published in 2026, this absence stands in contrast to the declared standards of the EAU Guidelines, whose published COI policy requires individual financial disclosures and restricts panel members from voting on recommendations for technologies in which they hold significant interests ^[10]. Whether or not the SIU is formally bound by EAU policy — it is not — the comparison illustrates a transparency gap that clinicians using this document as a reference should be aware of.

The following biographical facts are drawn from publicly verifiable sources — the document itself, PubMed author records, and published trial registries:

Peter Gilling serves as Co-Chair of Committee 4 (Invasive Surgical Treatments), which is responsible for the Aquablation chapter ^{[1, p. 152]}. He is also the first or senior author of the WATER randomised controlled trial and the WATER II single-arm study — the two pivotal trials that establish the evidence base for Aquablation and that are cited six times in the Aquablation chapter ^[3,4]. Both trials were conducted with device support from PROCEPT BioRobotics, as declared in their published disclosures.

To be clear about what this means structurally: the investigator who led the manufacturer-supported trials that validated Aquablation co-directed the committee that evaluated those trials and produced the recommendation for Aquablation, in a document whose production was financially supported by that manufacturer. This arrangement raises legitimate questions about the management of conflicts of interest, regardless of the scientific integrity of any individual involved. Gilling is also one of the world's foremost experts on HoLEP — a genuine authority on both technologies — which is precisely what makes the structural arrangement worth examining rather than dismissing.

Dean Elterman is the Editor of the entire consultation ^{[1, cover page]}. He is also first author of "Focal bladder neck cautery associated with low rate of post-Aquablation bleeding" (Elterman DS et al., Can J Urol, 2021), cited as Reference 9 in the Aquablation chapter ^{[1, p. 212]}. That paper is cited in the specific passage addressing the most significant safety signal in the Aquablation evidence base: the 9.9% pre-discharge bleeding rate and 5.9% transfusion rate documented in WATER II ^[4]. A publication authored by the document's editor addresses a complication of the sponsor's technology, within a chapter that the same editor oversaw. Readers should be aware of this layering when evaluating how the WATER II safety data is contextualised.

Elterman's consultancy and investigator relationship with PROCEPT BioRobotics is not a matter of inference — it is declared explicitly in his published papers, including the REAP global multicenter registry (World J Urol, 2023), where his disclosures read: "Dean Elterman is a consultant/investigator for… Procept BioRobotics…" ^[2]. This makes the absence of any equivalent declaration in the SIU-ICUD Consultation — a document he edited — the more conspicuous.

Kevin Zorn serves as Co-Chair of Committee 5 (BPH Minimally Invasive Treatments) ^{[1, p. 348]}, which covers Rezūm, UroLift, and Optilume — three technologies whose manufacturers are declared sponsors. His authorship on the Aquablation same-day discharge paper cited as Reference 5 in the Aquablation chapter, and his co-authorship on multiple papers on Rezūm cited in that chapter, are verifiable through PubMed author records.

These positional overlaps — between editorial authority and prior commercial research relationships — are presented here as structural observations, not as accusations of misconduct toward any individual.

III. The Quantitative Asymmetry

The AEEP/HoLEP chapter and the Aquablation chapter cover surgical procedures for the same clinical indication. Some editorial asymmetry is expected: Aquablation is a newer technology with more technical complexity to describe. But the nature — not only the magnitude — of the difference is worth examining:

	AEEP/HoLEP	Aquablation
Approximate word count	~1,875	~2,747
References	15	21
Sponsor-funded trial references	0	6 (WATER family)
Industry-supplied images	0	4 ("courtesy of PROCEPT BioRobotics")
Trademarked product names in text	0	2 (Aquabeam®, FirstAssist AI™)
Procedural video (SIU Academy)	None	Yes — Aquablation®
Level of Evidence	I (Ho:YAG)	II
Grade of Recommendation	A	B

The additional length in the Aquablation chapter is not composed of clinical evidence — it is composed in part of corporate image descriptions and promotional language. No other surgical technique in Committee 4 uses images from a device manufacturer. No other chapter reproduces trademarked marketing terminology in a figure caption.

IV. Corporate Images as Scientific Figures

Four figures in the Aquablation chapter carry the credit line "Image courtesy of PROCEPT BioRobotics Corporation." ^{[1, pp. 191–194]} One presents PROCEPT's HYDROS system with a caption describing it as featuring "AI-powered treatment planning with FirstAssist AI™, advanced image guidance, and a more streamlined workflow." ^{[1, p. 192]}

The term FirstAssist AI™ — with trademark symbol — appears verbatim in a clinical consultation published under the SIU imprimatur. The EAU Guidelines do not include manufacturer-supplied promotional images. The AUA Guidelines do not. This document does, for exactly one technology, whose manufacturer is a declared sponsor.

V. Opening Paragraphs as Evidence of Register

The Aquablation chapter opens ^{[1, p. 191]}:

"Aquablation has become an integral treatment option for surgeons to effectively manage BPH while minimizing possible side effects. Not only has the literature proved the success of Aquablation, but Aquablation has also been endorsed by all major society guidelines."

The AEEP chapter opens ^{[1, p. 178]}:

"Anatomical endoscopic enucleation of the prostate (AEEP) is a highly effective surgical technique used to treat BPH… These advancements have significantly improved patient outcomes, particularly for men with large prostate glands, by reducing morbidity, improving efficacy, and minimizing complications."

The second is technical and contextual. The first is a positioning statement structured around endorsement and market adoption. The Aquablation chapter closes ^{[1, p. 196]} describing "profound long-term outcomes" — the word profound does not appear in the conclusions of any other chapter in the surgical treatment section.

VI. Procedural Videos: The Most Objective Asymmetry

The document's preface highlights its procedural videos as an innovation ^{[1, p. VI]}. The procedures with SIU Academy® videos are: Aquablation® (PROCEPT BioRobotics — sponsor), Rezūm™ (Boston Scientific — sponsor), and Optilume® ^{[1, pp. 197, 270]}.

HoLEP — the procedure with Level I, Grade A evidence, the highest recommendation in the surgical section — has no procedural video. It is possible that logistical or licensing factors explain this absence; I have no access to the document's internal editorial communications. But the outcome is that the educational resource most effective for driving surgical adoption — video training — is provided exclusively for the procedures of declared sponsors, and not for the procedure with the strongest evidence base.

VII. The Volume Restriction: An Evidence Gap That Requires Explanation

The document's recommendation table stratifies by prostate volume as follows ^{[1, pp. 168, 183, 196]}:

Procedure	Recommended volume	LoE	GoR
TURP	30–80 mL	I	A
Aquablation	30–80 mL	II	B
AEEP/HoLEP	> 80 mL only	I	A

HoLEP is the only major endoscopic procedure in this table restricted to the large-prostate segment. This restriction is not explained in the chapter, and it is not consistent with the available evidence. Multiple Level I randomised controlled trials and meta-analyses include prostates well below 80 mL and demonstrate equivalent or superior outcomes for HoLEP versus TURP across the full volume range ^[5,6,7,8,9]. The 2024 EAU Guidelines on Non-neurogenic Male LUTS do not impose a lower volume threshold for endoscopic enucleation ^[10].

A case can be made for clinical caution: HoLEP's learning curve (~50 cases) is real, and in smaller prostates where TURP is technically straightforward, some clinicians consider enucleation less necessary. This is a legitimate clinical discussion. What is absent from the document is any explanation of why this restriction was applied to HoLEP but not to TURP — which also has a learning curve and a complication profile in smaller prostates. The absence of justification is what makes the restriction notable, not the restriction itself.

The practical consequence is significant. Prostates between 30 mL and 80 mL represent the majority of the BPH surgical population. The recommendation as written places HoLEP outside the volume range where Aquablation — a sponsor's technology with lower evidence grade — is recommended. An evidence-based justification for this asymmetry should have been provided.

VIII. The Neutralisation of the Bhatia Meta-Analysis

The document cites Bhatia et al. (2024), a network meta-analysis comparing Aquablation and HoLEP ^[11]. The document summarises its findings as follows ^{[1, p. 195]}:

"At 12 months, the HoLEP procedure was associated with better outcomes in terms of IPSS, QoL, PVR, and Qmax improvements, though it was associated with higher rates of incontinence. There was a higher risk of hemoglobin loss and risk of blood transfusion with Aquablation as well as higher rates of retreatment."

This is the document's own summary: HoLEP is superior in four primary functional outcomes; Aquablation has more bleeding complications and higher retreatment. The sentence that immediately follows ^{[1, p. 195]}:

"Despite the difference in functional outcomes, Aquablation operative time and hospital stays were significantly lower, presenting a compelling alternative in the outpatient setting."

The word despite performs significant editorial work here. It subordinates superiority across four functional measures to an operational scheduling consideration. This framing — where logistical advantage is positioned to offset clinical inferiority — merits scrutiny given the document's sponsorship structure. A methodological caveat is warranted: the Bhatia NMA covers 12-month outcomes, which is sufficient for functional comparison but does not capture the long-term durability advantage of HoLEP that emerges in studies with 7–10 year follow-up ^[4,5]. Even with that caveat, the document's characterisation of the evidence does not reflect the hierarchy of outcomes that patients typically prioritise.

IX. Technical Attribution: An Observation on Academic Practice

The document credits Peter Gilling and Fraundorfer as the developers of HoLEP using the Ho:YAG laser ^{[1, p. 179]}. This is historically accurate. The document then describes the en-bloc enucleation technique as follows ^{[1, p. 221]}:

"The en bloc technique for AEEP, which involves enucleating the entire transition zone adenoma as one tissue block, is increasingly being utilized for AEEP due to its improved enucleation efficiency and some reports of better early continence."

"Increasingly being utilized" and "some reports" are language choices that suggest an emerging, informally validated trend. In the same document, Gilling receives specific nominal credit as HoLEP's originator and six citations for the WATER trials. The contrast in attribution practices — named credit for the originating technique, anonymous treatment for a major technical evolution — is a pattern worth noting as a matter of academic convention, independent of any other argument in this article.

X. What the Document Contains That Is Valuable

The evidence grades in this document are real and correctly applied. The Level I, Grade A recommendation for HoLEP is present. The retreatment data for UroLift — 8–15% at five years ^[12] — is in the UroLift chapter. The superior functional outcomes for HoLEP in the Bhatia meta-analysis are cited. The WATER II bleeding data is present. The document does not fabricate evidence.

What it does is construct an editorial architecture around evidence that exists — through opening language, image selection, video provision, volume-restricted recommendations, and sentence-level framing choices — that consistently favours the technologies of its declared sponsors over the procedure with the highest level of evidence. This is how industry influence on clinical documents typically operates at present. The mechanism is present in the structure regardless of the intentions of any individual contributor.

The word unrestricted in the sponsor acknowledgment ^{[1, p. VI]} is doing significant work. The sponsors are named. Their products are covered. Their images are reproduced. Their videos are distributed under the SIU Academy label. Their funded-trial investigators co-chair the committees that evaluated their products. Individual authors do not declare conflicts of interest. These facts coexist in the same document.

XI. Recommendations for Clinicians and Health Systems

Use this document. It is comprehensive and largely accurate within the limits described above. Apply the following questions:

On evidence grades: HoLEP is Grade A, Aquablation is Grade B. This hierarchy is correctly stated. It should inform procurement and training decisions.

On the volume restriction for HoLEP: The >80 mL restriction is not supported by a body of evidence that excludes smaller prostates. Clinicians and health systems should consult the 2024 EAU Guidelines ^[10], which do not impose this restriction, before using this document's recommendation to exclude HoLEP from their treatment pathway for moderate-volume BPH.

On retreatment rates: Assemble and compare them independently. Published data, with appropriate caveats for different follow-up durations and study populations: HoLEP 0–1.4% at 7–10 years ^[4,5]; TURP 14.7% at 8 years ^{[1, p. 168]}; Rezūm 4–5% at 5 years ^[13]; UroLift 8–15% at 5 years ^[12]. These figures should be in any informed consent discussion.

On conflict-of-interest transparency: The 2024 EAU Guidelines ^[10] and the 2023 AUA/SUFU BPH Guideline ^[14] both publish individual COI declarations with specific financial disclosures. Cross-referencing this document's committee members against those declarations provides additional context.

XII. A Note on Formal Response

If the concerns raised in this article are shared by other clinicians and educators in this field, the most effective formal response would address three specific, documentable issues: (1) the absence of individual COI declarations, benchmarked against EAU and AUA policy; (2) the structural position of committee chairs with disclosed relationships to the technologies their committees evaluated; and (3) the absence of evidentiary justification for the >80 mL volume restriction on HoLEP recommendations, given the available Level I evidence across the full prostate volume range.

These are arguments that can be made on the basis of published evidence and documented policy comparisons, without requiring access to the document's internal editorial communications.

References

1. Elterman D, Gravas S, Tubaro A (Eds). SIU-ICUD Consultation: Individualized Management of Male LUTS. Société Internationale d'Urologie. March 2026. ISBN 978-1-0688136-1-0.
2. Gauhar V, Gómez Sancha F, Enikeev D, et al. Results from a global multicenter registry of 6193 patients to refine endoscopic anatomical enucleation of the prostate (REAP). World J Urol. 2023;41(11):3033–3040. doi:10.1007/s00345-023-04626-2
3. Gilling P, Barber N, Bidair M, et al. WATER: A double-blind, randomized, controlled trial of Aquablation® vs transurethral resection of the prostate in benign prostatic hyperplasia. J Urol. 2019;201(5):965–973. doi:10.1097/JU.0000000000000076
4. Desai M, Bidair M, Bhojani N, et al. WATER II (80–150 mL) procedural outcomes. BJU Int. 2019;123(1):106–112. doi:10.1111/bju.14360
5. Elmansy HM, Kotb A, Elhilali MM. Holmium laser enucleation of the prostate: long-term durability of clinical outcomes and complication rates during 10 years of followup. J Urol. 2011;186(5):1972–1976. doi:10.1016/j.juro.2011.07.015
6. Placer J, Gelabert-Mas A, Vallmanya F, et al. Holmium laser enucleation of prostate: outcome and complications of self-taught learning curve. Urology. 2009;73(5):1042–1048. doi:10.1016/j.urology.2008.10.074
7. Tan AHH, Gilling PJ, Kennett KM, et al. A randomized trial comparing holmium laser enucleation of the prostate with transurethral resection of the prostate for the treatment of bladder outlet obstruction. J Urol. 2003;170(4 Pt 1):1270–1274. doi:10.1097/01.ju.0000085341.13190.5e
8. Ahyai SA, Gilling P, Kaplan SA, et al. Meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic enlargement. Eur Urol. 2010;58(3):384–397. doi:10.1016/j.eururo.2010.06.005
9. Saitta G, Becerra JEA, Del Álamo JF, et al. En bloc HoLEP with early apical release in men with benign prostatic hyperplasia. World J Urol. 2019;37(11):2451–2458. doi:10.1007/s00345-019-02671-4
10. Gravas S, Gacci M, Gratzke C, et al. EAU Guidelines on Non-neurogenic Male Lower Urinary Tract Symptoms. European Association of Urology. 2024 Edition. uroweb.org/guidelines
11. Bhatia A, Titus R, Porto JG, et al. Comparing outcomes of Aquablation versus holmium laser enucleation of prostate in the treatment of benign prostatic hyperplasia: a network meta-analysis. BJUI Compass. 2024;5(12):1231–1245. doi:10.1002/bco2.454
12. Roehrborn CG, Barkin J, Gange SN, et al. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. 2017;24(3):8802–8813. PMID:28646935
13. McVary KT, Rogers T, Roehrborn CG. Rezūm water vapor thermal therapy for lower urinary tract symptoms associated with benign prostatic hyperplasia: 4-year results from randomized controlled study. Urology. 2019;126:171–179. doi:10.1016/j.urology.2018.12.031
14. Sandhu JS, Bixler BR, Dahm P, et al. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline (2023 Update). J Urol. 2023;210(1):11–19. doi:10.1097/JU.0000000000003698

Dr. Fernando Gómez Sancha is Medical Director of ICUA (Instituto de Cirugía Urológica Avanzada) at Clínica CEMTRO, Madrid. He has performed over 10,000 HoLEP procedures and trained urologists across 60 countries, generating direct professional income from that training. He discloses speaking and proctoring arrangements with Quanta System, Richard Wolf, and Andromeda Surgical — manufacturers of HoLEP equipment. He receives no payment from any manufacturer of devices discussed in this article. The author's direct interest in the broader adoption of HoLEP should be considered when evaluating the arguments presented here.

@fgomsan · ICUA.es · LinkedIn