Predictors of Symptomatic Relief in WVTT for Prostatic Hyperplasia: 36-Month Prospective Study

doi:10.21203/rs.3.rs-4877666/v1

Purpose

Existing literature lacks an analysis of factors predicting the achievement of minimum clinically important differences (MCID) after water vapor thermal therapy (WVTT) for prostatic hyperplasia. This study aims to identify these predictors over a 36-month post-WVTT period.

Methods

This prospective single surgeon case series assessed male patients receiving WVTT. Eligibility criteria included being at least 45 years old, having an estimated prostate volume (EPV) of 30–80 cc, an International Prostate Symptom Score (IPSS) of 12 points or more, and a maximum urinary flow rate (Qmax) under 16 mL/sec. MCID, representing the smallest symptomatic improvement perceived by patients, was calculated using the distribution-based method, considering half a standard deviation of baseline IPSS scores. Correlation and linear regression analyses assessed MCID attainment. Multivariate logistic regression evaluated MCID achievement, considering multicollinearity, heteroskedasticity, and normality.

Results

Of 206 men with a median 29.1-month follow-up (Range: 24–36), 13.6% didn't achieve MCID for IPSS, and 7.2% for QoL scores. Significant hindrances to MCID attainment for IPSS were a large median lobe (> 10mm protrusion) (OR = 3.01, 95% CI: 2.3–3.72), increased median lobe treatments (OR = 1.73, 95% CI: 1.23–2.35), and high preoperative irritative IPSS scores (OR = 1.25, 95% CI: 1.13–1.38). Factors for QoL MCID non-achievement included age over 75 (OR = 1.25, 95% CI: 1.13–1.38), a large median lobe (OR = 1.87, 95% CI: 1.62–2.01), and EPV over 60cc (OR = 1.55, 95% CI: 1.16–1.97). A 6.3% surgical re-intervention rate was noted.

Conclusions

The characteristics of the median lobe as well as the severity of lower urinary tract symptoms are crucial for treatment success. These should be integral to preoperative assessments and patient discussions on treatment options.

Water Vapor Thermal Therapy

Prostatic Hyperplasia

Minimum Clinically Important Difference

Symptomatic Improvement

Prospective Study

Treatment Outcomes

Benign prostatic hyperplasia (BPH) is common among adult men, manifesting as lower urinary tract symptoms (LUTS) that disrupt life. BPH treatment options vary in invasiveness, efficacy, and cost (1). Water Vapor Thermal Therapy (WVTT) (Rezum®) is less invasive, using steam to induce cell death and tissue shrinkage (2, 3) and effectively addresses different prostate lobe configurations (4, 5).

Studies indicate WVTT alleviates moderate-to-severe LUTS over several weeks and improves quality of life (QoL) while having few side effects and preserving sexual function. Its outpatient nature is beneficial, reducing the need for anesthesia, hospital stays, and risks associated with more invasive treatments(6, 7). Long-term studies up to five years post-treatment have shown a marked reduction in LUTS and improved urine flow (Qmax) (1, 2, 6, 8, 9).

Despite progress, research on the minimum clinically important differences (MCIDs) for LUTS interventions is lacking. MCIDs are vital for evaluating meaningful clinical outcomes, signifying the smallest change patients deem beneficial (10). MCIDs reflect true clinical impact beyond statistical significance, aiding therapeutic decisions and managing expectations (11). This study aims to define MCIDs for LUTS related to WVTT and identify clinical and intraoperative factors affecting these indicators. We aim to give patients and clinicians a clearer understanding of WVTT’s benefits and a standard for measuring treatment success. Our goal is to correlate MCIDs with patient-reported outcomes (PROMs), creating a framework for assessing WVTT’s real-world benefits in BPH management, ensuring QoL improvements are statistically and personally significant.

Study Design and Patient Eligibility

Patients were prospectively enrolled in the study from July 2020 to September 2023 after Institutional Review Board approval. Inclusion criteria encompassed males aged ≥ 45 years, estimated prostate volume (EPV) of 30–80 cc, International Prostate Symptom Score (IPSS) ≥ 12 points, and Qmax of < 16 mL/sec. Exclusions included prior prostate surgery or prostate cancer. Informed consent was obtained pre-enrollment. Preoperative assessments included EPV, post-void residual volume (PVR), prostate-specific antigen (PSA), IPSS, Male Sexual Health Questionnaire - Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF), endoscopic prostate measurement (EPM; number of fields of view, being 5mm equivalent to one field of view), evaluation of the presence of a median lobe (ML), endoscopic median lobe enlargement (eMLE), and the number of lateral and median lobe water vapor treatments. eMLE was used as it provides a direct visualization of the prostate and its anatomical features during cystoscopy, offering a more precise assessment of the median lobe compared to ultrasound. During cystoscopy, a ML was identified as a distinct protrusion and recorded as present or absent based on Eure et al. (12). A large median lobe (LML) was defined as a protrusion greater than 10 mm.

Surgical technique

Water vapor injections were delivered to both lateral lobes, 1 cm from the bladder neck and every 1 cm distally towards the verumontanum. MLs were treated with one or more additional injections administered at a 45° angle, lateral to medial. Post-surgery, patients had a catheter for 5–7 days based on EPV and the number of injections. Specifically, if the patient received 4 or fewer injections, the catheter was left in place for 5 days; if more than 4 injections were administered, the catheter remained for 7 days. Discharge included catheter valve training and a 10-day anti-inflammatory protocol with COX-2 inhibitors and NSAIDs.

Endpoints and Analysis of Minimum Clinically Important Difference (MCID)

The primary study objective was evaluating WVTT improvement on urinary symptoms via IPSS changes. MCID for IPSS and QoL was determined as the smallest clinically significant change perceived by patients. To estimate MCID, IPSS and QoL questionnaires were administered pre and post-treatment. MCID estimation employed distribution-based methodologies, specifically calculating 0.5 times the standard deviation of change scores.

Correlation Analysis of MCID Achievement

Correlation analyses were conducted to explore associations between diverse clinical and demographic variables and the attainment of MCID in IPSS and QoL. These variables included obstructive and irritative IPSS scores, prostate volume measurements, the number of treatments, and their relationships with the achievement of MCID. Variables that exhibited significant negative correlations with MCID accomplishment were identified as potential risk factors.

Statistical Analyses

Descriptive Analysis: Descriptive statistical methods were employed to summarize the baseline characteristics.

Comparison of IPSS and MSHQ-EjD-SF Scores: Statistical comparisons of IPSS and MSHQ-EjD-SF scores between baseline and various post-treatment time points (6 weeks, 3, 6-, 12-, 24- and 36-months post-surgery) were conducted using paired t-tests or Mann-Whitney tests, depending on data distribution (parametric or non-parametric). Significance was determined at p < 0.05.

Linear Regression Analysis: Linear regression examined IPSS and IPSS-QOL score relationships.

Multivariate Logistic Regression Analysis for MCID Achievement: Multivariate logistic regression was employed to investigate the associations between explanatory variables (age, estimated prostate volume, PVR, PSA level, baseline IPSS score, EPM, presence of ML, eMLE, and the number of water vapor treatments) and the likelihood of achieving the MCID. Belsley-Kuh-Welsch, White test, and Shapiro-Wilk test checked multicollinearity, heteroskedasticity, and normality. Significance was at p < 0.05.

A total of 206 men were enrolled and followed for a median of 29.1 months (range = 4–38). Average age was 61.9 years (range= 50-87; SD=8.6), and average PSA was 1.7 ng/mL (range=0.3–21; SD=3.7). Median EPV was 52.3 cc (range=35–81; SD=16.4). Median Qmax, IPSS, IPSS-QoL, and PVR were 11 mL/sec, 21 points, 5 points, and 62 cc, respectively. The majority of patients (83%; n=171) were on pharmaceutical therapy, with most receiving tamsulosin (81.8%; n=140). The remaining patients (18.2%; n=31) were treated with a combination of tamsulosin and dutasteride (Table 1). Average visual endoscopic prostate length was 2.3 cm. ML was detected in 113 patients (54.8%) and within this group, 21.2% had LML (n=24). Average duration of surgery was 3 minutes (range=1–4.5; SD=0.8), with a median of 6 injections (range=2–10; SD=1.5) per patient. There were no intraoperative complications. All patients were discharged the day of surgery. Average duration of catheterization was 6.85 days (range=3–14; SD=1.91) (Table 1).

At 6 weeks, 3 months, 6 months, 12 months, 24 months and 36 months IPSS and IPSS-QoL were significantly lower than at baseline (p=0.03 and 0.01 respectively, at twelve months), accompanied by a significant improvement in Qmax (p=0.01). At 36 months, IPSS had decreased by 58.6%, and Qmax had improved by 5.2 mL/s (Figure 1). By 6 weeks, all patients had discontinued pharmacological treatment for BPH. Regarding ejaculation, MSHQ-EjD-SF question one showed an initial increase from 7.5 to 10.4 at twelve months, followed by a slight decrease to 9.9 at twenty-four months. Question two initially decreased from 1.8 to 1.4 at six weeks, but subsequently improved to 1.6 at twelve months, which then remained stable up to twenty-four months.

Regarding adverse events, acute urinary retention (AUR) was observed in 10.2% (n=21) of cases, of which 85.7% (n=18) experienced the retention within the first 7 days post-catheter removal, and urinary tract infection (UTI) occurred in 5.8% (n=12) of patients. There were no reports of new-onset urinary incontinence post-procedure. During the median follow-up period of 29.1 months, Clavien-Dindo grade III complications were recorded in two patients (0.97%). One patient required anesthesia for bladder clot evacuation in the operating room three months after surgery. The other patient needed percutaneous drainage for a urinoma, which we assumed occurred due to a prostatic capsule perforation in a small-sized prostate. Within the follow-up period, surgical re-intervention was required in 6.3% of cases. Of these, 23% (n=3) underwent Transurethral Resection of the Prostate (TURP) within six months post-WVTT, primarily to address scar tissue formation within the prostate (prostatic sinechiae), cavities formed below the bladder trigone (infratrigonal cavitary lesions), and remaining dead prostate tissue. The remainder of the re-intervened cohort (n=10) underwent laser enucleation, all of which took place after the first year of follow-up.

The assessment of MCID for IPSS and QoL score was conducted by comparing preoperative values with those obtained 36 months postoperatively. Within the cohort, 13.6% of patients (n=28) did not reach the MCID for the IPSS, and 7.2% (n=15) did not attain the MCID for QoL Scores. The regression analyses aimed to discern factors associated with the non-achievement of MCID yielded the following: in the IPSS model, a LML was associated with an odds ratio (OR) of 3.01 (95% CI: 2.3 - 3.72; p=0.017), indicating an increased risk of not achieving MCID. Furthermore, an elevated number of treatments to the ML (≥ 2 injections) had an OR of 1.73 (95% CI: 1.23-2.35; p=0.038), and a high preoperative irritative IPSS score (≥ 7) was linked with an OR of 1.25 (95% CI: 1.13-1.38; p=0.03), both factors being predictive of not reaching MCID. Regarding the QoL domain, factors associated with not achieving MCID included age (≥75) with an OR of 1.25 (95% CI: 1.13-1.38; p= 0.023), the presence of a LML with an OR of 1.87 (95% CI: 1.62-2.01; p= 0.029), and a EPV ≥ 60cc with an OR of 1.55 (95% CI: 1.16-1.97; p= 0.034) (Table 1).

Table 1. Comprehensive Baseline Characteristics, Intraoperative Findings, and Postoperative Outcomes in Patients Undergoing WVTT and Predictors of Failure to Achieve MCID for IPSS and QoL

Baseline Characteristics, Prostate Characteristics and Baseline Symptoms
Variables	Mean	SD	Median	Range
Age	61.9	8.6	61	50.0-84.0
Baseline IPSS	21.17	7.2	22	5.0-35.0
Obstructive IPSS Domain	11.95	4.6	12	4.0-18.0
Irritative IPSS Domain	8.9	3.6	9	1.0-15.0
Cardiovascular Disease (CDV) Score	5.12	0.9	5	3.0-6.0
Baseline UFM (mL/s)	11.5	4.6	11	2.60-15.80
Pelvic Ultrasound Volume (cc)	52.3	16.4	46	35.0-81.0
MRI Volume (mL)	59.8	14.5	71	38.0-82.0
PVR (cc)	98.96	88.4	70	0-375.0
PSA (ng/mL)	3.2	3.4	1.97	0.19-21.80
Medical Therapy	83% (n=171)	-	-	-
- Tamsulosin	81.8% (n=140)	-	-	-
- Tamsulosin + Dutasteride	18.2% (n=31)	-	-	-
Follow-up (months)	24.5	-	29.1	24.0 - 36.0
Follow-up (months)	24.5	-	29.1	24.0 - 36.0
Intraoperative Findings and Postoperative Course
Variables	Results	SD	Range/Details
Endoscopic Length of Prostate (cm)	2.3	0.45	2-3
Presence of Median Lobe (n/total)	113/206	-	54.80%
Median Lobe larger than 1cm (n/total)	24/113	-	21.20%
Number of Injections (#)	6	1.5	2 – 9
Intraoperative Complications (#)	0	-	None
Catheterization (Days)	6.85	1.91	3-14
Factors Associated with Failure to Achieve MCID for IPSS and IPSS-QoL
Scale Association	Factor	Odds Ratio (95% CI)		P-Value
IPSS	Large Median Lobe (LML)	3.01 (2.3 - 3.72)		0.017
	≥ 2 Median Lobe Treatments	1.73 (1.23-2.35)		0.038
	Preoperative Irritative IPSS Score ≥ 7	1.25 (1.13-1.38)		0.03
IPSS-QoL	Age ≥ 75 - Quality of Life	1.25 (1.13-1.38)		0.023
	Large Median Lobe (LML)	1.87 (1.62-2.01)		0.029
	Estimated Prostate Volume (EPV) ≥ 60cc	1.55 (1.16-1.97)		0.034

30-50% of men over 50 suffer from LUTS due to BPH, with higher rates in those over 80 (13,14). TURP, the gold standard for BPH, is linked to frequent adverse events (15). Laser and plasma vaporization techniques have arisen as minimally invasive alternatives with similar outcomes and complication rates (16) Since the FDA approval of the Rezūm® system in 2015, WVTT provides targeted water vapor therapy to treat enlarged prostate tissue with precision (6). WVTT demands little anesthesia, effectively reduces LUTS, and safeguards sexual function (17).

Our study assessed Rezūm® therapy's efficacy in reducing urinary symptoms according to IPSS and enhancing quality of life, while also examining the MCIDs to determine patient and clinical factors that affect the full benefits of WVTT. We emphasized MCIDs to better interpret PROMs and used a composite treatment durability endpoint—including retreatment rates and IPSS change—to evaluate the long-term advantages of WVTT (2) .

WVTT has proven to significantly alleviate symptoms and enhance urinary flow (4,18). It emerges as a new standard in BPH treatment for those seeking non-pharmacological or less invasive options. Balancing efficacy with quality of life, WVTT aligns with current treatment priorities, particularly with its promising outcomes and sustained patient satisfaction, reducing the likelihood of additional interventions (2).

Our findings affirm that WVTT is an effective long-term BPH management strategy, aligning with the existing evidence(13). We observed a mean improvement of 58.6% in the IPSS scores, indicating a substantial reduction in the severity of LUTS. This improvement reflects a significant patient-perceived amelioration in symptoms. Concurrently, an average increase of 5.2 mL/s in Qmax was noted, indicative of micturition enhancement. These findings echo the results of Miller et al., noting consistent improvements in IPSS and Qmax, and a low surgical retreatment rate of 7.0% at four years compared to our reintervention rate of 6.3% at a median follow-up of 29.1 months (9,19). Our research also aligns with McVary & Roehrborn, who reported a 160% improvement in IPSS compared to control subjects over three years (19). Additionally, Alegorides et al. observed a 61.5% reduction in IPSS after one year, with patients liberated from bladder catheterization without serious adverse effects (20). Ghahhari et al. corroborate these observations, showing significant and consistent enhancements in Qmax and IPSS at 18-month intervals (21). Underpinning the long-term benefits of WVTT, McVary et al. demonstrated sustained LUTS improvement over five years, underscoring the procedure's longevity and safety (19). Collectively, this body of work substantiates WVTT's role as a minimally invasive, effective, and safe intervention for LUTS due to BPH, though the long-term efficacy beyond 10 years remains to be established.

Our MCID analysis for IPSS and QoL, sheds light on PROMs interpretability and clinical significance alignment. The MCID benchmarks set in this study are reflective of meaningful patient-perceived improvements. Hossack and Woo demonstrated that improvements in IPSS and QoL scores post-photoselective vaporization of the prostate correlated significantly with patient satisfaction, underscoring the importance of MCID in evaluating patient outcomes (22). Similarly, Nordanstig et al. assessed the MCID for Vascular Quality of Life Questionnaire-6 in patients undergoing peripheral artery disease revascularization, providing a framework for the interpretation of QoL improvements in a different patient population (11). Our findings of only 13.6% and 7.2% of patients not reaching the MCID for IPSS and QoL respectively, suggest a significant proportion of patients perceive a clinically meaningful benefit from WVTT. Our results are consistent with the burgeoning consensus that PROMs are critical for post-operative evaluation, ensuring that the treatment effects are meaningful to the patients themselves. The use of a composite treatment durability metric, further emphasizes the significance of aligning clinical outcomes with patient-valued changes (13).

We analyzed a range of clinical and operative characteristics, alongside outcome measures, to identify factors associated with a reduced probability of surpassing the MCID threshold for LUTS, as measured by the IPSS. Our findings indicated that a larger median lobe, a higher number of treatments to the median lobe (≥2 injections), and an elevated preoperative IPSS score (≥7) were all predictive factors associated with a higher probability of not achieving MCID. The cutoff of 7 on the IPSS scale helps identify patients who, although presenting with mild symptoms, may still experience a significant impact on their quality of life and may require clinical intervention. Studies have shown that even mild symptoms can lead to considerable discomfort and management challenges for patients (23,24). Martinez et al., highlighted the technical challenges and impact on urinary function that an enlarged median lobe can present during prostatectomy which may be analogous to the challenges a median lobe poses in achieving full efficacy of treatment with WVTT (25). Moreover, the requirement for multiple treatments often indicates more extensive BPH, which can complicate the therapeutic process. Eure et al. suggest that while challenging anatomical features, such as obstructive median lobes, can be effectively managed, a higher number of necessary treatments reflects greater tissue volume and complexity (12). This increased complexity can adversely affect the likelihood of achieving MCIDs due to the higher procedural burden and potential for residual symptomatic tissue. This is in keeping with the composite treatment durability metric, which considers not only symptom relief but also the avoidance of additional medical or surgical interventions (12). Our observation that an elevated preoperative IPSS score is associated with a lesser likelihood of achieving MCID resonates with findings from Bodokh et al., where initial symptom severity could impact the functional results (26). These findings suggest that while the median lobe's characteristics crucially influence treatment outcomes, the severity of LUTS and the number of interventions are equally significant in determining the efficacy of treatment and, hence, should be integral to preoperative assessments and patient counseling.

Our study, while robust in its prospective design and comprehensive outcome measures, is not without limitations. The single-arm nature of the study precludes direct comparison with alternative treatments and introduces the potential for selection bias, thereby affecting the interpretation of the results. Additionally, relying on PROMs, despite their validity, can introduce a degree of subjectivity in measuring and interpreting the MCIDs, especially considering the subjective nature of improvements perceived differently among individuals. However, these limitations are balanced by the study’s strengths, including the systematic prospective data collection, well-defined inclusion criteria, and the utilization of MCIDs to contextualize the clinical relevance of treatment effects.

Moving forward, there is a need for long-term studies extending beyond the 36-month period to understand the enduring effectiveness of WVTT. Comparative studies with other treatment modalities, such as traditional surgical methods or alternative minimally invasive options, could provide a more nuanced understanding of WVTT's relative efficacy. Larger multi-center trials could enhance the generalizability of our findings and confirm the benefits observed in different patient demographics, including varying prostate sizes and configurations. Future research should also explore WVTT's impact on sexual function and urinary continence in the long term, which are critical considerations for patient quality of life.

Our study validates WVTT as a viable, patient-centric treatment for BPH, offering significant symptom relief with minimal invasiveness. Through the application of MCIDs, we highlight the importance of PROMs, enabling clinicians to align therapeutic strategies with individual patient needs and expectations. The integration of such metrics into clinical practice is essential, underscoring the shift towards personalized, outcome-focused care.

Acknowledgments:

We would like to express our sincere gratitude to all those who provided their invaluable support during the course of this research. Our appreciation extends to the participants of our study for their time and valuable contributions. Lastly, we acknowledge the efforts of the peer reviewers whose insights helped to refine this work significantly.

Authors’ Contributions:

J.F: Conceptualization, methodology, validation, formal analysis, investigation, resources, writing—original draft, writing— review and editing, visualization, supervision, project administration, funding acquisition.

J.S.A.: Formal analysis, investigation, data curation, writing—original draft, writing—review and editing, visualization, project administration.

R.M., D.G., P.V.B., S.A.C., T.A.Z., B.G.: Formal analysis, investigation, writing—original draft, writing—review and editing, visualization.

F.L.,M.A.P.: Conceptualization, methodology, validation, writing—original draft, writing—review and editing, supervision, project administration.

Author Disclosure Statement:

No competing financial interests exist.

Funding Information:

This study received no financial support of any kind.

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No competing interests reported.

Predictors of Symptomatic Relief in WVTT for Prostatic Hyperplasia: 36-Month Prospective Study

Status:

Journal Publication

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Abstract

Purpose

Methods

Results

Conclusions

Figures

Introduction

Methods

Study Design and Patient Eligibility

Surgical technique

Endpoints and Analysis of Minimum Clinically Important Difference (MCID)

Correlation Analysis of MCID Achievement

Statistical Analyses

Results

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

Journal Publication

Version 1