Take Home Message
Mini–holmium laser enucleation of the prostate significantly reduces post–holmium laser enucleation of the prostate (HoLEP) urinary incontinence rates and improves recovery times compared with standard 26 Fr HoLEP. It also presents a better intraoperative profile and procedural efficiency while maintaining no significant differences in symptom relief, urinary flow improvement, and safety outcomes.
Keywords: Benign prostatic hyperplasia, Holmium laser, Enucleation surgery
Abstract
Background and objective
Holmium laser enucleation of the prostate (HoLEP) is increasingly performed with miniaturized instruments, aiming to reduce postoperative urinary incontinence (UI). Evidence for mini-HoLEP (MiLEP) using a 22-Fr resectoscope remains largely retrospective or nonrandomized. We aimed to compare MiLEP with a standard 26 Fr HoLEP in a prospective randomized trial.
Methods
Ninety men were randomized to MiLEP (n = 45) or HoLEP (n = 45). All procedures were performed by one surgeon using a standardized technique. The prespecified primary end point was UI, defined as any reported loss of urine, at 1 mo. Key secondary end points included UI at 2 mo and at the end of follow-up.
Key findings and limitations
Median follow-up was 828 days. UI at 1 mo was lower after MiLEP than HoLEP (22.2% vs 51.1%; odds ratio [OR] 0.27; 95% confidence interval [CI] = 0.11–0.67; p = 0.004). UI at 2 mo was also lower (8.9% vs 24.4%; OR 0.30; 95% CI = 0.09–0.99; p = 0.048), whereas long-term UI did not differ significantly (2.2% vs 6.7%; p = 0.61). MiLEP also lowered the need for meatal dilation (15% vs 51%; p < 0.001), irrigation volume (16 vs 24 l; p < 0.001), and improved core temperature maintenance (+0.1 °C vs –0.1 °C; p < 0.001), with higher median enucleation efficiency (1.22 vs 1.0; p = 0.003) and not statistically different operative time, complications, and functional improvement. Limitations include the inability to blind the surgeon and limited power for uncommon events.
Conclusions and clinical implications
MiLEP seems to improve early continence recovery, supporting miniaturization as a strategy to enhance patient-centered outcomes after HoLEP.
ADVANCING PRACTICE.
What does this study add?
This study confirms and, for the first time, provides a decent level of evidence supporting MiLEP’s advantages over standard HoLEP. Those include lower rates of transient post-HoLEP UI, improved early continence recovery, less need for meatal dilation, lower irrigation volume, and improved core temperature maintenance, with higher enucleation efficiency and no statistically significant differences in operative time, complications, and functional results.
Clinical Relevance
Instrument miniaturization may represent a simple and clinically meaningful strategy to reduce early morbidity after HoLEP without compromising surgical efficacy. The reduction in early urinary incontinence is particularly relevant for patient recovery and satisfaction. However, the single-center, single-surgeon design and limited power for uncommon complications warrant confirmation in larger multicenter trials. Associate Editor: Véronique Phé.
Patient Summary
We compared a slimmer version of a prostate laser procedure with the standard one. The slimmer instrument led to less urine leakage in the first weeks after surgery. Long-term symptom relief and urine flow improvements were not different, with a similar safety profile.
1. Introduction
Holmium laser enucleation of the prostate (HoLEP) is an established, endoscopic surgical treatment for symptomatic or complicated benign prostatic obstruction (BPO) and is endorsed by the American Urological Association and European Association of Urology guidelines as an adenoma-size and age-independent procedure [1], [2]. Despite its excellent functional results and safety profile, nonnegligible rates of transient postoperative urinary incontinence (UI) and low rates of urethral strictures or contracted bladder neck formation can negatively affect its outcome and patient satisfaction [3].
To improve and overcome these drawbacks, HoLEP’s surgical evolution has progressed from advances in enucleation and sphincter-preserving techniques, through refinements in laser technology and energy settings, and has now entered an era of instrument miniaturization [4], [5]. Although standard HoLEP is typically performed with instruments in the range of 24–28 Fr, mini-HoLEP (MiLEP) refers to HoLEP performed with a 22 Fr integrated system [6]. Early series and comparative studies have reported promising feasibility, safety, and, in some cases, improved effectiveness [7], [8], [9], [10], [11], [12]. Yet, this prior evidence for MiLEP is derived mainly from retrospective cohorts with at most propensity-matched analyses and prospective noncomparison series [7], [8], [9], [10], [11], [12]. This prospective randomized study aimed to compare MiLEP and HoLEP in terms of postoperative outcomes with long-term follow-up.
2. Materials and methods
2.1. Study design
We conducted a prospective, sample size–calculated randomized controlled trial comparing 26 Fr HoLEP with 22 Fr MiLEP. The trial was approved by the institutional review board (#0739-22-TLV). All participants provided informed consent in accordance with the Declaration of Helsinki.
2.2. Patients
Consecutive men presenting for endoscopic enucleation of the prostate (EEP) between March 2023 and April 2024 were recruited to the trial on the day of referral to surgery. Exclusion criteria consisted of prior surgical interventions for BPO, urethral strictures, bladder calculi, concomitant surgical treatments (eg, transurethral resection of bladder tumor, ureteroscopy, percutaneous nephrolithotomy, etc.), and patients with cognitive impairment. The compared variables included age, prostate size by abdominal ultrasound (US), preoperative indwelling catheter, prostate-specific antigen level, American Society of Anesthesiologists class, body mass index (BMI), diabetes mellitus rates, International Prostate Symptom Score (IPSS) and quality-of-life (QoL) item, uroflowmetry and postvoid urine residual (PVR) parameters, serum hemoglobin, creatinine, and sodium.
2.3. Randomization and masking
Patients were randomized in a 1:1 ratio to MiLEP or standard HoLEP using a computer-generated randomization sequence. Allocation concealment was ensured through a secure, password-protected electronic randomization system that was accessed only after informed consent, confirmation of eligibility, and patient enrollment. The treatment assignment was then communicated to the operating surgeon immediately before surgery.
2.4. Surgical technique
All procedures were performed by a single surgeon using a standardized endoscopic enucleation en bloc technique with early apical release. Data regarding laser settings, standardized warming irrigation, and thromboembolic prophylaxis can be found elsewhere [7]. The intervention differed only by the resectoscope size: 26 Fr (Storz, Tuttlingen, Germany) versus 22 Fr (RZ-Medizintechnik GmbH, Tuttlingen, Germany). After surgery, all patients received continuous bladder irrigation, which was subsequently reduced or discontinued according to the degree of hematuria. Blood tests were obtained the morning after the surgery, when the catheter was removed in the absence of a contraindication (eg, bleeding, fever).
2.5. Outcome measures
The primary end point was UI at 1 mo after surgery. Key secondary end points were UI at 2 mo after surgery and at the end of follow-up. UI was considered positive for any level of patient-reported urine loss. Patients were blinded to the instrument used. Postoperative continence was assessed by one of four evaluators, depending on clinic assignment on the day of follow-up, who directly asked the patients: “Do you experience any degree of unintended urine loss since the surgery?” Given that patient-reported UI after HoLEP is frequently mixed-type, we did not further subclassify UI into stress or urge incontinence [13]. Other secondary end points included need for meatal dilation; irrigation volume; core temperature change from beginning to end of surgery; operative time; enucleated tissue weight; enucleation efficiency (g/min); perioperative changes in hemoglobin, creatinine, and sodium; length of stay; postoperative complications; postoperative prescription rates of antimuscarinic or β3-adrenergic medications; IPSS improvement; maximum urinary flow rate (Qmax) and PVR improvement; and stricture formation.
2.6. Sample size and statistical analysis
Stata version 17.0 (StataCorp LLC, TX, USA) was used for statistical analysis. Based on our previously published propensity score–matched study, this trial was powered to detect a 25% absolute difference in 1-mo UI rates favoring MiLEP (15% vs 40%) [7]. Aiming for 80% power with a one-sided α of 0.05, the required sample size was calculated as 78 patients (39 per arm). Assuming a 15% expected attrition, we aimed to enroll 90 patients (45 per arm). Continuous variables were summarized as mean ± standard deviation or median (interquartile range [IQR]) based on distribution. Between-group comparisons used the Welch t-test or Mann-Whitney U test for continuous or ordinal variables and the chi-square test for categorical variables. Odds ratio (OR) confidence intervals (CIs) were calculated using the score method. Multivariable logistic regression was used to identify independent predictors of UI; covariates were chosen a priori based on clinical relevance. Although the sample-size calculation was based on a prespecified directional hypothesis, all reported between-group comparisons were conservatively performed using two-sided tests, and two-sided p values are presented throughout the manuscript. Two-sided p < 0.05 was considered statistically significant.
3. Results
The Consolidated Standards of Reporting Trials flow diagram (Fig. 1) summarizes participant screening, enrollment, randomization, and analysis: 105 patients underwent EEP in our medical center during the trial period; all were assessed for eligibility, 90 were randomized (45 MiLEP; 45 HoLEP), and all randomized participants were included in the final analysis. Median follow-up was 828 d (IQR = 745–939), corresponding to ∼2.27 yr (IQR = 2.04–2.57). The surgeon himself was the follow-up evaluator in 28% of the cases. Follow-up duration was similar between groups (p = 0.61). Baseline characteristics are presented in Table 1. Randomization yielded generally well-balanced groups.
Fig. 1.
CONSORT Flow diagram. CONSORT = Consolidated Standards of Reporting Trials; HoLEP = holmium laser enucleation of the prostate; MiLEP = mini–holmium laser enucleation of the prostate.
Table 1.
Baseline characteristics by treatment arm
| HoLEP (n = 45) | MiLEP (n = 45) | |
|---|---|---|
| Age (yr), median (IQR) | 72 (67–77) | 73 (68–79) |
| BMI (kg/m2), median (IQR) | 25.2 (23.4–28.7) | 26.6 (24.4–30) |
| ASA class, n (%) | ||
| ASA 1 | 7 (15) | 6 (13) |
| ASA 2 | 29 (64) | 33 (73) |
| ASA 3 | 9 (20) | 6 (13) |
| Diabetes mellitus, n (%) | 10 (22) | 11 (24) |
| Prostate volume (cm3), median (IQR) | 101 (87–130) | 90 (75–125) |
| Preoperative indwelling catheter, n (%) | 19 (42) | 12 (26) |
| PSA (ng/ml), median (IQR) | 6 (3.41–9.4) | 7.25 (3.69–10.97) |
| IPSS total score, median (IQR) | 32 (22–35) | 26 (22–35) |
| IPSS QoL item, median (IQR) | 6 (5–6) | 5 (5–6) |
| Qmax (ml/s), median (IQR) | 7.0 (6.0–8.0) | 6.2 (5.4–7.0) |
| PVR (cm3), median (IQR) | 110 (43.35–170) | 140 (72–190) |
| Hemoglobin preoperative (g/dl), mean (SD) | 13.5 ± 1.4 | 13.5 ± 1.5 |
| Sodium preoperative (mmol/l), mean (SD) | 138.8 ± 2.7 | 138.3 ± 2.8 |
ASA = American Society of Anesthesiologists; PSA = prostate-specific antigen; IPSS = International Prostate Symptom Score; QoL = quality of life; PVR = postvoid residual volume; HoLEP = holmium laser enucleation of the prostate; MiLEP = mini–holmium laser enucleation of the prostate; IQR = interquartile range; BMI = body mass index; SD = standard deviation; Qmax = maximum urinary flow rate.
3.1. Primary and key secondary outcomes
At 1 mo postoperatively, UI (as defined above) was observed in 10 of the 45 (22%) patients in the MiLEP arm, significantly lower compared with 23 of the 45 (51%) in the 26 Fr HoLEP arm, corresponding to an unadjusted OR of 0.27 (95% CI = 0.11–0.67; p = 0.004). By 2 mo, UI rates decreased in both groups to 4 of the 45 (8.9%) versus 11 of the 45 (24%), respectively; the MiLEP arm had significantly lower UI rates, corresponding to an unadjusted OR of 0.30 (95% CI = 0.09–0.99; p = 0.048). Long-term UI was documented in 1 of the 45 (2.2%) patients in the MiLEP versus 3 of the 45 (6.7%) patients in the standard HoLEP arm (p = 0.61; Table 2).
Table 2.
Functional outcomes
| HoLEP (n = 45) | MiLEP (n = 45) | p value | |
|---|---|---|---|
| UI at 1 mo, n (%) | 23 (51) | 10 (22) | 0.009 |
| UI at 2 mo, n (%) | 11 (24) | 4 (8.9) | 0.047 |
| UI at the end of follow-up, n (%) | 3 (6.7) | 1 (2.2) | 0.61 |
| Medication for urge sensation, n (%) | 17 (37) | 13 (28) | 0.5 |
| Urethral stricture, n (%) | 4 (8.9) | 2 (4.4) | 0.67 |
| Δ IPSS, median (IQR) | −21.5 (−26 to −13) | −17 (−23 to −11) | 0.49 |
| Δ IPSS QoL item, median (IQR) | −4 (−5 to −3) | −4 (−5 to −2) | 0.77 |
| Δ Qmax, median (IQR) | 7 (3.08−13.38) | 9.25 (4.52−13.12) | 0.56 |
| Δ PVR, median (IQR) | −82 (−138 to −27) | −66 (−156 to −32) | 0.7 |
UI = urinary incontinence; IPSS = International Prostate Symptom Score; QoL = quality of life; PVR = postvoid residual volume; HoLEP = holmium laser enucleation of the prostate; MiLEP = mini–holmium laser enucleation of the prostate; IQR = interquartile range; Qmax = maximum urinary flow rate.
Prostate volume as assessed by abdominal US was strongly correlated with the duration of surgery (r = 0.81). Thus, given the limited number of outcome events, we restricted multivariable analysis to the most clinically relevant covariates to minimize overfitting and avoid collinearity. In the resulting model adjusting for age, catheterization status, and prostate size, MiLEP was associated with lower odds of 1-mo UI (adjusted OR 0.23; 95% CI = 0.09–0.6; p = 0.003). In a sensitivity analysis using Firth bias-reduced logistic regression adjusting for the same covariates, MiLEP remained associated with lower odds of 1-mo UI (adjusted OR 0.25; 95% CI = 0.10–0.65).
3.2. Other secondary outcomes
Intraoperative and early postoperative outcomes are shown in Table 3. Compared with standard HoLEP, MiLEP required significantly less meatal dilation and was associated with lower irrigation volume and improved maintenance of core body temperature. Operative time and enucleated tissue weight were not statistically different, whereas median efficiency (g/min) was significantly better in the MiLEP arm (1.22 [IQR = 1.06–1.4] vs 1.0 [IQR = 0.71–1.23]; p = 0.003). Perioperative changes in hemoglobin, sodium, and early urinary retention rate immediately after catheter removal were not statistically different. Other postoperative adverse events were relatively rare and included catheter displacement because of bladder neck undermining, urinary tract infection, and readmission because of hematuria.
Table 3.
Intraoperative and early postoperative outcomes
| HoLEP (n = 45) | MiLEP (n = 45) | p value | |
|---|---|---|---|
| Required meatal dilation, n (%) | 23 (51) | 7 (15) | <0.001 |
| Operative time (min), median (IQR) | 70 (60–80) | 60 (50–90) | 0.19 |
| Beach balls, n (%) | 6 (13) | 1 (2.2) | 0.11 |
| Pathology weight (g), median (IQR) | 70 (50–90) | 75 (60–95) | 0.41 |
| Efficiency (g/min), median (IQR) | 1.0 (0.71–1.23) | 1.22 (1.06–1.4) | 0.003 |
| Irrigation volume (l), median (IQR) | 24 (18–27) | 16 (12–21) | <0.001 |
| Δ core temperature (°C), median (IQR) | −0.1 (−0.3 to 0) | 0.1 (0–0.2) | <0.001 |
| Δ hemoglobin (g/dl), median (IQR) | −0.7 (−1.4 to 0.15) | −0.65 (−1.98 to −0.2) | 0.2 |
| Δ Sodium (mmol/l), median (IQR) | −1.0 (−3.0 to 0.0) | −1.0 (−2.0 to 0.75) | 0.49 |
| Early urinary retention, n (%) | 2 (4.4) | 3 (6.6) | 0.64 |
| Catheter displacement, n (%) | 2 (4.4) | 0 | 0.15 |
| Urinary tract infection, n (%) | 0 | 1 (2.2) | 0.31 |
| Readmission because of hematuria, n (%) | 1 (2.2) | 1 (2.2) | 1 |
| Δ PSA, median (IQR) | −5.39 (−8.23 to −2.66) | −6.95 (−11.01 to −3.36) | 0.3 |
PSA = Prostate-specific antigen; HoLEP = holmium laser enucleation of the prostate; MiLEP = mini–holmium laser enucleation of the prostate; IQR = interquartile range. Bold = statistically significant.
Other functional outcomes are also summarized in Table 2. The early postoperative prescription rates of antimuscarinic or β3-adrenergic medications for urge symptoms were not statistically different (p = 0.5). Among patients who received these medications, most were able to discontinue treatment during follow-up, with discontinuation rates not statistically different between groups (p = 0.44). Urethral stricture rates were numerically lower after MiLEP but were not significantly different, occurring in 2 of the 45 (4.4%) versus 4 of the 45 (8.9%) patients in the HoLEP arm (p = 0.67). There were no cases of postoperative contracted bladder neck. Both techniques resulted in substantial symptom improvement and increased urinary flow without statistically significant between-group differences in IPSS, QoL, Qmax, and PVR improvements.
4. Discussion
Minimally invasive approaches have improved outcomes across many surgical fields, including urology. The field has progressed from open surgery with large incisions to laparoscopy, and from large to small trocars across reconstructive, functional, and oncologic urology [14]. In endourology, ureteroscopes have been downsized to as small as 4.5 Fr, and mini-percutaneous nephrolithotomy has been introduced [15]. However, the downsizing of transurethral resectoscopes progressed far more slowly: it took 24 yr (1926–1950) to decrease from the original 33 Fr to instruments in the 24–28 Fr range, and a further 72 yr (1950–2022) to introduce 22 Fr (“slim”) and 18.5 Fr (“ultraslim”) laser enucleation sets [6], [16], [17], [18]. This slow pace likely reflected delayed recognition of the benefits of downsizing, along with technological limitations in maintaining optimal performance with smaller instruments. In our opinion, the ideal laser resectoscope would allow HoLEP to be performed without urethral dilation, minimize mucosal friction, provide sufficient irrigation for clear visualization, and incorporate, within the same outer sheath, an integrated morcescope and a fulguration capability. Compared with a 26 Fr scope, a 22 Fr scope represents a 15% reduction in diameter, consistent with the rationale of minimizing urethral trauma [6], [7].
Two recent prospective comparative studies and one meta-analysis reflect the interest in HoLEP miniaturization. Dean et al [19] found no clear advantage when comparing 24 Fr and 28 Fr instruments with respect to short-term stress UI, urethral stricture, or bladder neck contracture, reporting similar effectiveness in 76 patients per group. However, the study did not evaluate early recovery or late complications, and the sample size was powered to detect differences in operative time only. Ozsoy et al [8] conducted a study in a group of 150 patients allocated to either mini (22 Fr) or standard (26 Fr) laser resectoscopes, with allocation determined by instrument availability. Although described as a prospective randomized study, this allocation approach resulted in numerically and clinically imbalanced groups, with fewer patients and significantly smaller prostates in the 22 Fr cohort. Given this considerable bias, the authors reported that no intraoperative meatotomies or urethrotomies were necessary in their miniaturized cohort compared with 12.5% of patients in the standard group and concluded that MiLEP may be a suitable option for selected patients, particularly those with lower urethral compliance and smaller prostate volume [8]. Finally, a meta-analysis comparing EEP performed with 22–24 Fr versus 26–28 Fr instruments showed comparable effectiveness with smaller scopes in terms of operative and enucleation time. Larger scopes were associated with a modest advantage in morcellation time; however, smaller scopes were linked to significantly better 1-mo continence, a significantly lower need for urethral dilation, and numerically lower need for urethral stricture, without reaching statistical significance [20].
Our study provides a decent level of evidence: it is prospective and randomized, powered for UI as the primary outcome, and includes long-term follow-up. In this context, we found that MiLEP significantly reduced early postoperative UI with a risk reduction of ∼30% at 1 mo and ∼15% at 2 mo postoperatively.
The use of MiLEP was also associated with better intraoperative profiles, including a markedly reduced need for meatal dilation with a 35% risk reduction, lower irrigation volumes, improved maintenance of core body temperature during the procedure, and better enucleation efficiency as measured by grams of removed tissue per minute. The greater efficiency may be explained by time savings resulting from the lack of need for urethral dilation and for switching from an obturator to the resectoscope. The device is introduced ready for use, with the laser fiber already in place, fully loaded, without the need to replace components or introduce the laser fiber separately. All other outcomes, including symptom relief and improvements in urinary flow, were not significantly different from standard HoLEP.
It should be mentioned that these secondary outcomes were evaluated across multiple between-group comparisons without adjustment for multiplicity and should therefore be interpreted as exploratory and hypothesis generating. Some statistically significant secondary findings may have occurred by chance and require confirmation in adequately powered studies specifically designed to assess these outcomes. Nonetheless, these findings are consistently concordant with prior studies, reinforcing that MiLEP provides a perioperative advantage without compromising other functional outcomes [7], [8], [12].
Beyond reducing urethral trauma, we believe MiLEP lowers postoperative UI by significantly minimizing sphincteric overdilation—an explanatory mechanism for post-HoLEP UI presented by Schwarztuch Gildor and Mendelson et al [21]. Using their model, the estimated urethral dilation during HoLEP for a typical 100 cm3 adenoma in a patient with a 2-cm membranous urethra is decreased by 14% when using MiLEP compared with a standard 26 Fr device.
Urethral stricture formation rates were lower in the MiLEP arm (4.4%) than in the standard HoLEP arm (8.9%). Although this difference did not reach statistical significance, the direction of effect aligns with the intuitive expectation that a smaller-caliber resectoscope may lessen urethral and meatal trauma during instrumentation. Being powered for UI, our study could not reveal significance for the differences in urethral strictures. Based on our calculations, reliably assessing this complication would require ∼800 patients per group, an accrual target feasible only through a multicenter prospective study, which we plan to initiate in the future.
MiLEP should be attractive for any patient, but especially for patients with previously reported risk factors for post-HoLEP UI (eg, age, elevated BMI, indwelling catheter, etc.) [22], [23]. We focused our miniaturization assessment on the 22 Fr MiLEP because the 18.5 Fr set, although commercially available, is not integrated, meaning that for completing the morcellation, the resectoscope should be replaced with a set ≥22 Fr [6].
The main limitation of this study is the inability to blind the surgeon to treatment allocation and his partial involvement in postoperative outcome assessment. However, follow-up evaluations were not performed solely by the operating surgeon and could be conducted by other manuscript coauthors. Nonsurgeon evaluators were blinded to allocation because resectoscope size was not documented in the operative report. Nevertheless, assessment bias cannot be completely excluded and should be considered when interpreting the study outcomes.
Other limitations include this study’s single-center, single-surgeon design and limited power for uncommon end points (eg, stricture). The large number of secondary between-group comparisons and the absence of adjustment for multiple testing increase the possibility of type I error; therefore, findings other than the prespecified primary end point should be considered exploratory and hypothesis generating. Nonetheless, the randomized design, standardized surgical technique by a single experienced surgeon, and comprehensive capture of perioperative and functional outcomes all serve to support the robustness and validity of our findings despite potential sources of bias.
5. Conclusions
Our study provides evidence that miniaturizing the resectoscope is a practical strategy to improve early continence recovery after HoLEP. As blinded evaluation might be a concern in our study, multicenter, prospective, well-powered studies with blinded evaluation are needed to further define MiLEP’s role in early continence recovery and in reducing urethral strictures and bladder neck contracture.
Author contributions: Mario Sofer had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Sofer, de Figueiredo.
Acquisition of data: Mendelson, Confino, Gildor, Savin, Taha, Bashi, Lifshitz, Veredgorn, Sofer.
Analysis and interpretation of data: Mendelson, Gildor, Savin, Sofer.
Drafting of the manuscript: Mendelson, Gildor, Savin, Sofer.
Critical revision of the manuscript for important intellectual content: Sofer.
Statistical analysis: Mendelson, Gildor, Savin, Sofer.
Obtaining funding: None.
Administrative, technical, or material support: Mendelson, Confino, Gildor, Savin, Taha, Bashi, Lifshitz, Veredgorn, Sofer.
Supervision: Yossepowitch, Sofer.
Other: None.
Financial disclosures: Mario Sofer certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None.
Funding/Support and role of the sponsor: None.
Associate Editor: Véronique Phé
Statistical Editor: Rod Dunn
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