Abstract
Purpose
This study investigated the factors associated with transient urinary incontinence (TUI) after holmium laser enucleation of the prostate (HoLEP) as a palliative treatment in patients with severe bladder outlet obstruction (BOO) and advanced prostate cancer (PCA).
Materials and Methods
Data of 28 patients with advanced PCA (≥cT3) who underwent palliative HoLEP between October 2018 and March 2021 were included in this retrospective study. After collection of the pre-, intra-, and postoperative (1, 3, and 12 months) data of patients from their medical records, variables of patients with and without TUI at 1 and 3–12 months postoperatively were statistically compared. Multivariate analysis was performed to investigate the factors associated with postoperative TUI.
Results
Compared to baseline, the mean total international prostate symptom score, quality of life score, maximum flow rate (Qmax), and postvoid residual (PVR) were significantly improved 1 month postoperatively, and this was maintained until 12 months postoperatively (p<0.001). Of the 28 patients, 14 (50.00%) and 6 (21.43%) presented with TUI at 1 and 3–12 months postoperatively, respectively. Patients with TUI at 1 month follow-up showed a significantly lower preoperative Qmax (p=0.027), larger preoperative PVR (p=0.004), and higher likelihood of bladder neck tumor invasion (p=0.046). Conversely, patients with TUI at 3–12 months postoperatively were significantly older (p=0.033) and had a longer enucleation time (p=0.033). Multivariate analysis demonstrated that the factors affecting TUI were preoperative Qmax (odds ratio [OR]=0.61; 95% confidence interval [CI]=0.39–0.93; p=0.016) and bladder invasion of the tumor (OR=26.72; 95% CI=1.83–390.42; p=0.022) after 1 month; however, none of the variables correlated significantly with TUI at 3–12 months.
Conclusions
Palliative HoLEP is an effective management option in patients with advanced PCA-related BOO. Lower preoperative Qmax and bladder neck tumor invasion are the factors affecting TUI at 1 month postoperatively.
Keywords: Holmium, Prostatic neoplasms, Urinary bladder neck obstruction, Urinary incontinence
INTRODUCTION
Advanced prostate cancer (PCA) remains a significant global healthcare concern, with its incidence expected to rise to 1.7 million new cases by 2030 [1]. Among the complications associated with advanced PCA, bladder outlet obstruction (BOO) is one of the most debilitating, leading to considerable morbidity and negatively affecting patient quality of life (QoL) [2,3]. Conventional surgical interventions, such as transurethral resection of the prostate (TURP), are the gold standard treatment for patients with BOO caused by benign prostatic hyperplasia (BPH). However, these approaches are associated with significant risks such as bleeding and infection [4,5], and TURP may be inappropriate for patients with advanced PCA who are unsuitable for curative treatments or have a limited life expectancy owing to cancer progression.
Holmium laser enucleation of the prostate (HoLEP) has recently emerged as a promising, minimally invasive alternative to traditional surgical interventions for BOO [6,7,8]. HoLEP offers better outcomes in terms of effectiveness and reduced adverse effects than TURP, with studies reporting shorter hospital stays, reduced blood loss, and lower rates of perioperative complications [9]. However, despite the growing evidence supporting the efficacy of HoLEP in BPH management, data on its role in advanced PCA-related BOO remain limited.
Moreover, a critical patient-centered outcome in the context of BOO management is postoperative transient urinary incontinence (TUI), which significantly affects patients’ physical and emotional well-being [10]. Several studies have investigated the risk factors for postoperative urinary incontinence (UI) after HoLEP in patients without cancer, including age, total operation time, preoperative prostate volume, diabetes mellitus, and preoperative international prostate symptom score (IPSS) [11,12]. However, there is a paucity of literature examining the factors affecting TUI following HoLEP in patients with advanced PCA-related BOO.
Therefore, the aim of this study was to investigate the effectiveness of palliative HoLEP in managing refractory BOO in patients with advanced PCA and to identify the factors associated with postoperative TUI. Our study findings could provide valuable insights into the use of HoLEP as a palliative treatment option for patients with advanced PCA and refractory BOO and help guide clinical decision-making to improve patient outcomes.
MATERIALS AND METHODS
1. Patients and data acquisition
A total of 28 patients with advanced PCA (≥cT3 and/or any N and/or any M) who had experienced urinary retention owing to BOO and had undergone palliative HoLEP between October 2018 and March 2021 were included in this retrospective review. None of the patients had a history of voiding dysfunction caused by neurologic deficit, other genitourinary malignancy, and urologic surgery. Transrectal ultrasound-guided prostate biopsy was performed to confirm PCA. The TNM staging system of the American Joint Committee on Cancer [13] was used to determine the clinical stage of the disease based on digital rectal examination, multiparametric magnetic resonance imaging, and bone scans. Lower urinary tract symptom status and voiding function were evaluated preoperatively and at 1, 3, and 12 months postoperatively using IPSS, QoL score, uroflowmetry, and postvoid residual (PVR). The volumes of the prostate and adenoma were estimated using transrectal ultrasonography, and local invasiveness of the PCA was determined using multiparametric magnetic resonance imaging. Intraoperative data such as enucleation time, resected adenoma volume, and morcellation time were collected, and the enucleation efficiency was calculated by dividing the resected adenoma volume by the enucleation time. Postoperative complications and hemoglobin level decreases were also investigated to evaluate the safety of palliative HoLEP. UI, which refers to the involuntary leakage of urine that gives rise to hygienic or social challenges for the individual, was defined in accordance with the criteria outlined by the International Continence Society. The presence of UI was also assessed through a specific question posed to the participants: “Do you have involuntary loss of urine?” [14].
2. Surgical procedure
In this study, a 100 W holmium: yttrium-aluminium-garnet laser source (VersaPulse PowerSuite, Lumenis, Yokneam, Israel), a 550 µm end-firing fiber (SlimLine, Lumenis, Yokneam, Israel), and a modified continuous-flow 26F resectoscope (Karl Storz, Tuttlingen, Germany) were used to perform HoLEP. A video system and continuous isotonic sodium chloride solution irrigation were also required. A laser power setting of 2.5 J at 40 Hz was routinely used for the enucleation of the prostatic adenoma and hemostasis.
All procedures in this study were carried out by a single experienced surgeon, and due to the surgeon’s preference, all patients underwent enucleation using the “two-lobe technique”. The procedure began with an incision in the mucosa at the five o’clock (left side) or seven o’clock position (right side) of the prostatic urethra, specifically at the verumontanum level. As the incision reached the surgical plane of the prostate capsule, the lateral adenoma (depending on the side of the mucosal incision) was continuously peeled off in the anteroposterior direction using a laser, ensuring that the capsule plane remained secure. When the lateral lobe had been completely separated from the prostate capsule, it was pushed into the bladder. Subsequently, the median lobe, which was incorporated with the other lateral lobe, was enucleated as a single piece, starting from the surgical plane exposed at the lateral border of the median lobe. After removing all adenomas from the bladder, the remaining adenoma and floppy fibrous tissues were trimmed and hemostasis was achieved before morcellation was performed. The enucleated adenoma was extracted from the bladder using a mechanical tissue morcellator (Versacut, Lumenis, Yokneam, Israel) introduced via an indirect nephroscope (Karl Storz, Tuttlingen, Germany). Finally, at the conclusion of surgery, a 3-way 20–24 Fr Foley catheter was inserted, and a 3 L bag of 0.9% isotonic sodium chloride solution was connected to ensure continuous bladder irrigation.
3. Data analysis
The results are presented as the mean and standard deviation (SD) (expressed as mean±SD) or median and interquartile ranges (IQR) (expressed as median [IQR]) unless otherwise specified. The change in each postoperative outcome parameter for treatment effectiveness was analyzed using repeated-measures ANOVA. The Mann–Whitney U-test and Fisher’s exact test were used to verify the factors affecting postoperative TUI, and logistic regression was performed for multivariate analysis. The results were considered statistically significant at p<0.05. All statistical analyses were performed using PASW Statistics ver. 18.0 (IBM Corp.).
4. Ethics statement
This study was approved by the Institutional Review Board of the Pusan National University Hospital, Busan, South Korea (No. 2402-031-136). The requirement to obtain informed consent was waived.
RESULTS
The mean age of the patients was 70.18±7.29 years and 25 patients (89.29%) were being managed with androgen deprivation therapy when palliative HoLEP was performed. None of the patients received radiation therapy for PCA before or after surgery. Preoperatively, 22 patients (78.57%) experienced acute urinary retention and 17 (77.27%) of them maintained urethral catheterization until the day of surgery. The mean prostate volume was 61.39±14.67 g, and adenoma inconsistency within the prostate—which we defined as the adenoma that has invaded through the surgical margin—and bladder neck tumor invasion were detected in 12 (42.86%) and 18 (64.29%) patients, respectively. Other demographic and perioperative patient data are shown in Table 1.
Table 1. Demographic and perioperative data of the patients.
| Category | Value | |
|---|---|---|
| Number of patients | 28 | |
| Mean age (y) | 70.18±7.29 | |
| ECOG performance status | ||
| ≤1 | 21 (75.00) | |
| 2 | 7 (25.00) | |
| Mean serum PSA (ng/mL) | 33.91±31.89 | |
| Mean prostate volume (g) | 61.39±14.67 | |
| Clinical stage | ||
| T3 | 10 (35.71) | |
| T4 | 18 (64.29) | |
| N1 | 18 (64.29) | |
| M1 | 12 (42.86) | |
| Number of patients with ADT | 25 (89.29) | |
| Number of patients with AUR | 22 (78.57) | |
| Mean enucleated adenoma weight (g) | 22.36±10.06 | |
| Mean enucleation time (min) | 43.43±14.63 | |
| Mean enucleation efficiency (g/min) | 0.55±0.27 | |
| Mean morcellation time (min) | 8.79±5.55 | |
| Number of patients with adenoma inconsistency within the prostate | 12 (42.86) | |
| Number of patients with bladder neck invasion of the tumor | 18 (64.29) | |
| Mean catheterization duration (h) | 48.95±20.30 | |
| Mean hospitalization duration (day) | 3.13±1.99 | |
| Mean postoperative hemoglobin drop (g/dL) | 0.67±0.68 | |
| Postoperative complication | ||
| Urinary incontinence | 14 (50.00) | |
| Urinary retention | 3 (10.71) | |
| Urethral stricture | 2 (7.14) | |
Values are presented as mean±standard deviation or number (%).
ECOG: Eastern Cooperative Oncology Group, PSA: prostate-specific antigen, ADT: androgen deprivation therapy, AUR: acute urinary retention.
The mean IPSS and QoL score were significantly improved at 1 month postoperatively than at baseline (from 32.15±1.90 to 15.52±6.14, and 5.78±0.42 to 2.15±1.29, respectively), and the improved state was maintained until 12 months postoperatively (p<0.001 in all). Also, a significant increase and reduction of mean maximum flow rate (Qmax) and PVR, respectively, were noted at 1 month postoperatively compared with baseline (from 6.37±3.12 mL/s to 11.36±4.00 mL/s, and from 422.37±349.96 mL to 89.74±74.71 mL, respectively); these conditions were also maintained until 12 months postoperatively (p<0.001 in all, Fig. 1). All patients were discharged catheter-free.
Fig. 1. Functional voiding outcomes after holmium laser enucleation of the prostate as a palliative treatment in patients with severe bladder outlet obstruction and advanced prostate cancer. (A) International prostate symptom score (IPSS), (B) quality of life (QoL) score, (C) maximum flow rate (Qmax), (D) postvoid residual (PVR). Post OP: postoperative. *p<0.001.
No postoperative complications other than TUI (n=14, 50.0%), urinary retention (n=3, 10.71%), and urethral stricture (n=2, 7.14%) were observed during the study period. The number of patients requiring pads decreased to six (21.43%) between 3 and 12 months postoperatively. Patients with urinary retention visited the emergency center within a week of discharge, and their symptoms had resolved after a week of catheterization. The anterior urethral strictures occurred 3 and 6 months postoperatively; both patients were successfully managed with a single urethral dilatation. No significant bleeding was observed during surgery, resulting in a mean postoperative hemoglobin drop of 0.67±0.68 g/dL (from 13.83±1.54 g/dL preoperatively to 13.15±1.52 g/dL postoperatively, p=0.02). No postoperative transfusions were required in any patient.
One month postoperatively, patients with TUI showed a significantly lower preoperative Qmax (p=0.027), larger preoperative PVR (p=0.004), and a higher rate of bladder neck tumor invasion than those without TUI (p=0.046). According to multivariate analysis, the preoperative Qmax (odds ratio [OR]=0.61; 95% confidence interval [CI]=0.39–0.93; p=0.016) and bladder neck tumor invasion (OR=26.72; 95% CI=1.83–390.42; p=0.022) were the only significant factors affecting postoperative TUI. The prostate volume also tended to be smaller in patients with TUI than in those without; however, this difference was not statistically significant (p=0.051; Table 2).
Table 2. Factors of urinary incontinence (UI) at 1 month after holmium laser enucleation of the prostate as a palliative management in severe bladder outlet obstruction patients with advanced prostate cancer.
| No UIa (n=14) | UIb (n=14) | p-value | Multivariable analysis | |||
|---|---|---|---|---|---|---|
| OR | 95% CI | p-value | ||||
| Median age (y) | 66.50 (64.00–74.25) | 71.50 (65.50–79.50) | 0.420 | |||
| Median preoperative IPSS | 32.50 (30.00–34.25) | 32.00 (31.00–33.00) | 0.995 | |||
| Median preoperative QoL | 6.00 (5.00–6.00) | 6.00 (6.00–6.00) | 0.366 | |||
| Median preoperative Qmax (mL/s) | 7.90 (3.28–10.38) | 5.55 (2.58–6.53) | 0.027 | 0.61 | 0.39–0.93 | 0.016 |
| Median preoperative PVR (mL) | 127.50 (93.50–471.50) | 555.00 (282.50–725.00) | 0.004 | 1.00 | 0.89–1.04 | 0.685 |
| Median prostate volume (g) | 67.90 (59.03–74.35) | 53.50 (42.25–68.75) | 0.051 | |||
| Median enucleation time (min) | 46.00 (41.50–57.00) | 36.00 (30.00–44.00) | 0.098 | |||
| Median resected adenoma volume (g) | 19.00 (14.75–36.00) | 18.00 (14.75–28.00) | 0.460 | |||
| Median enucleation efficiency (g/min) | 0.50 (0.30–0.83) | 0.45 (0.30–0.70) | 0.626 | |||
| Median morcellation time (min) | 7.00 (5.00–10.00) | 7.00 (5.00–12.00) | 0.574 | |||
| Median total operation time (min) | 54.50 (50.00–67.75) | 43.00 (35.00–59.00) | 0.118 | |||
| Number of AUR history | 10 (71.43) | 12 (85.71) | 0.648 | |||
| Bladder neck invasion of tumor (+) | 6 (42.86) | 12 (85.71) | 0.046 | 26.72 | 1.83–390.42 | 0.022 |
| Adenoma inconsistency | 4 (28.57) | 8 (57.14) | 0.252 | |||
Values are presented as median (interquartile range) or number (%).
IPSS: international prostate symptom score, QoL: quality of life, Qmax: maximum flow rate, PVR: postvoid residual, AUR: acute urinary retention, OR: odds ratio, CI: confidence interval.
aPatients without UI. bPatients with UI.
UI was observed in 6 patients (21.43%) at 3 months postoperatively and it persisted until 12 months after surgery. The UI group had a significantly older age (p=0.033) and longer enucleation time (p=0.033) than the group without UI. However, none of these variables were significant factors for UI according to the multivariate analysis (OR=1.84, 95% CI=0.83–4.06; p=0.133 and OR=1.26, 95% CI=0.97–1.62; p=0.081, respectively; Table 3).
Table 3. Factors of urinary incontinence (UI) at 3–12 months after holmium laser enucleation of the prostate as a palliative management in severe bladder outlet obstruction patients with advanced prostate cancer.
| No UIa (n=22) | UIb (n=6) | p-value | Multivariable analysis | |||
|---|---|---|---|---|---|---|
| OR | 95% CI | p-value | ||||
| Median age (y) | 66.50 (64.00–73.25) | 74.50 (71.75–79.50) | 0.033 | 1.84 | 0.83–4.06 | 0.133 |
| Median preoperative IPSS | 32.00 (31.00–34.25) | 32.00 (28.75–33.00) | 0.283 | |||
| Median preoperative QoL | 6.00 (6.00–6.00) | 6.00 (5.00–6.00) | 0.604 | |||
| Median preoperative Qmax (mL/s) | 5.55 (2.88–7.75) | 8.50 (6.45–9.85) | 0.059 | |||
| Median preoperative PVR (mL) | 265.00 (131.25–595.00) | 575.00 (105.50–1,125.00) | 0.365 | |||
| Median prostate volume (g) | 63.50 (52.30–71.00) | 55.50 (47.30–78.30) | 0.849 | |||
| Median enucleation time (min) | 42.50 (30.00–47.00) | 61.50 (36.50–75.75) | 0.033 | 1.26 | 0.97–1.62 | 0.081 |
| Median resected adenoma volume (g) | 17.50 (14.75–30.50) | 18.00 (14.75–32.00) | 0.892 | |||
| Median enucleation efficiency (g/min) | 0.60 (0.30–0.83) | 0.40 (0.20–0.50) | 0.078 | |||
| Median morcellation time (min) | 7.00 (5.00–10.00) | 7.00 (7.00–12.00) | 0.336 | |||
| Median total operation time (min) | 50.00 (35.00–59.00) | 68.50 (43.50–87.75) | 0.059 | |||
| Number of AUR history | 16 (72.73) | 6 (100) | 0.198 | |||
| Bladder neck invasion of tumor (+) | 14 (63.64) | 4 (66.67) | 0.642 | |||
| Adenoma inconsistency | 10 (45.46) | 2 (33.33) | 0.673 | |||
Values are presented as median (interquartile range) or number (%).
IPSS: international prostate symptom score, QoL: quality of life, Qmax: maximum flow rate, PVR: postvoid residual, AUR: acute urinary retention, OR: odds ratio, CI: confidence interval.
aPatients without UI. bPatients with UI.
DISCUSSION
This study demonstrated that HoLEP is a durable surgical procedure that can effectively manage BOO in patients with advanced PCA, without severe perioperative and postoperative complications. The significant improvements in IPSS, QoL score, Qmax, and PVR up to 12 months after surgery indicate substantial improvements in both subjective and objective outcomes, demonstrating the effectiveness of HoLEP in managing BOO in patients with advanced PCA. Although the statistical analysis revealed significantly lower postoperative hemoglobin levels than at baseline, with a mean difference of only 0.67±0.68 g/dL, this small change is unlikely to have significant practical implications from a clinical standpoint. Notably, none of the patients required perioperative transfusion or experienced anemia or hypovolemia, suggesting that HoLEP in patients with advanced PCA is safe in terms of bleeding. Furthermore, no severe complications were reported following the procedure, and the average catheterization time and hospitalization duration were approximately 2 to 3 days. These findings suggest that HoLEP is a safe surgical approach for patients with advanced PCA and refractory BOO.
There is limited evidence on the effectiveness of HoLEP in managing refractory BOO in patients with advanced PCA; only a few similar studies have reported results consistent with those of our current study. A study published in 2020 [15] reported significant postoperative improvements in total IPSS, QoL score, Qmax, and PVR without any serious complications until 18 months postoperatively. Another study conducted in 2014 [16] mentioned that HoLEP is a suitable treatment option not only for patients with advanced PCA and BOO, but also for those scheduled for radiation therapy or surveillance for presumably indolent diseases. The conclusions of these studies are consistent with those of our study, implying that HoLEP is a practical, safe, and efficient treatment option for managing BOO in patients with advanced PCA who are unable to undergo radical prostatectomy.
UI after prostate surgery is a significant concern for both patients and clinicians [17,18,19]. It significantly affects patients’ QoL and causes involuntary urine loss, which can lead to hygiene and social issues. Clinicians also find the symptoms of incontinence to be highly distressing. Although research on HoLEP for BPH suggests favorable outcomes in terms of postoperative TUI [20,21], in the present study, complications were observed in 50% of the patients at 1 month follow-up. Patients who experienced TUI within a month postoperatively exhibited a significantly lower preoperative Qmax, greater preoperative PVR, and a higher proportion of bladder neck tumor invasion than those without TUI. These patients tended to have smaller prostate volumes; however, the statistical significance was marginal, and this lack of statistical significance could be attributed to small sample size or variability. To validate whether these variables contributed to TUI, multivariate analysis was conducted, revealing that preoperative Qmax and bladder neck tumor invasion were significant predictors of TUI occurrence.
A lower preoperative Qmax is speculated to be associated with an increased likelihood of TUI because of its potential correlation with bladder neck tumor invasion. Nevertheless, according to the comparison analysis (Mann–Whitney U-test), no significant difference was observed in the preoperative Qmax between patients with and without bladder neck tumor invasion (6.0 mL/s [2.88–8.10 mL/s] and 6.45 mL/s [3.28–8.95 mL/s], respectively; p=0.689). Although the preoperative Qmax has been identified as a statistically significant factor for postoperative TUI, its low OR of 0.61 suggests limited clinical relevance. The presence of bladder neck tumor invasion has also emerged as a significant predictor of TUI. This finding may be attributed to the greater surgical complexity or the indistinct boundaries of the external urethral sphincter in patients with bladder neck tumor invasion, potentially leading to postoperative TUI as a consequence of iatrogenic external urethral sphincter injury. Preserving tissue near the external urethral sphincter as much as possible, while minimizing obstruction during enucleation, may mitigate this risk. However, further studies specifically on enucleation techniques to prevent UI are required to confirm this hypothesis.
In six patients (21.43%) who experienced UI 3 months after HoLEP, the symptoms persisted for up to 12 months postoperatively. These patients were significantly older and had significantly longer enucleation times than those who recovered from TUI by 3 months postoperatively; however, these two variables were not significant factors for persistent UI according to multivariate analysis. These results suggest that despite the two factors potentially being associated with persistent UI, the current results may not be statistically significant because of the small number of patients.
Although bladder neck tumor invasion was a significant factor for TUI within a month after HoLEP, it did not remain a significant factor for persisting UI at 3 or more months postoperatively. This result indicates that even though bladder neck tumor invasion can be considered a factor for TUI, it may not be regarded as an important long-term complication of HoLEP.
This study had limitations that warrant consideration. As the data were acquired through a retrospective review of medical records, the results may be subject to inherent biases that impact their accuracy. Additionally, the small sample size may have reduced the statistical power of the tests employed in this study, potentially limiting the generalizability of the findings. To address these limitations and corroborate our findings, future research should employ a well-structured prospective study design with a larger pool of participants.
CONCLUSIONS
This study demonstrated that HoLEP can serve as a safe and effective palliative treatment option for patients with severe advanced PCA-related BOO, even in patients with a destroyed surgical plane within the prostate gland. In addition, although bladder neck tumor invasion may have contributed to the occurrence of postoperative TUI, it did not significantly affect UI persistence. These findings highlight the potential of HoLEP in improving the QoL of these patients by alleviating their symptoms while also considering the challenges posed by the advanced stage of their disease. Identifying factors associated with postoperative TUI after HoLEP may help improve patient outcomes and guide clinical decision-making.
Acknowledgements
None.
Footnotes
Conflict of Interest: The authors have nothing to disclose.
Funding: This work was supported by the National Research Foundation of Korea (NRF) grant funded by the Korean Government (MSIT) (No. RS-2023-00277502).
- Conceptualization: TNK, DGS.
- Data curation: HWK.
- Formal analysis: HWK.
- Funding acquisition: HWK.
- Investigation: JZL, DGS, TNK.
- Methodology: JZL, TNK.
- Software: HWK.
- Supervision: DGS.
- Validation: HWK.
- Writing – original draft: HWK.
- Writing – review & editing: HWK, TNK, JZL, DGS.
Data Sharing Statement
The data analyzed for this study have been deposited in HARVARD Dataverse and are available at https://doi.org/10.7910/DVN/PVA1NM.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data analyzed for this study have been deposited in HARVARD Dataverse and are available at https://doi.org/10.7910/DVN/PVA1NM.