A Prospective Study Comparing Suprapubic Catheter to Urethral Catheter on Voiding Outcomes and Complications After Whole-Gland Prostate Cryoablation for Prostate Cancer

Abstract

Objective:

This study aimed to prospectively compare the impact of suprapubic catheter (SPC) vs urethral catheter (UC) drainage on perioperative complications and functional outcomes after transperineal whole-gland prostate cryoablation for localized prostate cancer.

Patients and Methods:

Between October 2021 and December 2024, 67 patients underwent whole-gland prostate cryoablation at our institution; 52 were eligible for analysis, of whom 19 received an SPC and 33 a UC in a nonrandomized manner based on surgeon preference. Perioperative data were prospectively collected, including catheterization time, urinary retention, infections, and voiding outcomes at 12 months. Comparative analyses were performed, and logistic regression was used to identify predictors of post-treatment urinary retention.

Results:

The SPC group had a significantly longer median time to effective voiding trial than the UC group (50 vs 20 days, p = 0.022). Urinary retention necessitating transurethral operation occurred more frequently in the SPC group (26.3% vs 9.1%), although this did not reach statistical significance (p = 0.124). Seminal tract infections were observed exclusively in the SPC group (15.8%, p = 0.044). No significant differences were observed in de novo incontinence and 12-month voiding outcomes. Multivariable logistic regression with backward selection did not identify any independent predictors of higher odds of urinary retention.

Conclusion:

Compared with UC, the use of SPC after prostate cryoablation was associated with longer catheterization time and a higher rate of both urinary retention requiring operation and seminal tract infections. Although SPC may improve comfort, its use should be carefully individualized based on patient risk factors.

Keywords

prostate cryoablation suprapubic catheter urethral catheter urinary retention complications

Introduction

Cryoablation is a minimally invasive transperineal ablative technique that can be used in the setting of clinical trials for treating organ-confined prostate cancer (PCa). Cryoablation relies on freezing and thawing to induce cell death by dehydration, protein denaturation, direct rupture of cellular membranes by ice crystals, vascular stasis, and formation of microthrombi; all such events result into ischemic necrosis.^1–3

Although the efficacy and safety of this procedure are objects of continuous investigation, little attention has been paid to the optimization of peri-procedural strategies. Similar to other ablative procedures, cryoablation requires temporary bladder drainage until resolution of treatment-related tissue edema and inflammation to avoid recurrent urinary retention. Although an indwelling urethral catheter (UC) certainly represents the simplest and most accessible method for urine drainage, it is associated with various urethral problems such as discomfort, pain, infection, and stricture.⁴ Conversely, a suprapubic catheter (SPC) avoids direct contact with the urethra, suggesting a potential to reduce urethral-related complications. In addition, SPC facilitates clamping trials until the return of spontaneous voiding.^5–7

To the best of our knowledge, there is no study comparing patients having SPC vs UC in the settings of transperineal cryoablation of the whole prostate. Therefore, this prospective study aims to compare the impact of the SPC and the UC bladder drainage strategy on voiding function and complications in patients undergoing whole-gland prostate cryoablation for organ-confined PCa.

Patients and Methods

Study population

Data of patients diagnosed with organ-confined PCa and scheduled for cryoablation at our department between October 2021 and December 2024 were prospectively collected. Inclusion criterion for cryoablation was patients unfit for radical prostatectomy or patients unwilling to undergo surgery/external beam radiotherapy. Patients with indwelling urethral catheters at baseline, patients who had already undergone operation for benign prostatic obstruction or urethral stricture, and patients with incomplete data or missed at follow-up were excluded. Preoperatively, all patients underwent midstream urine culture and uroflowmetry (UFM), including peak flow rate (PFR), and postvoid residual volume (PVR) assessed by suprapubic ultrasound. In addition, all patients completed the International Prostate Symptom Score (IPSS) questionnaire to evaluate the presence and severity of lower urinary tract symptoms. This study was approved by the institutional review board (DICUNT 02/2021).

Cryotherapy technique

All patients underwent whole-gland cryoablation under spinal anesthesia in the lithotomic position. Under transrectal ultrasound guidance (BK Medical Flex Focus 500), cryoprobes were inserted percutaneously through the perineum into the prostate. Using the ICEFX system (Boston Scientific), argon gas was circulated through the needles to rapidly lower prostate tissue temperature below –40°C. This freezing cycle was followed by an active thawing phase to enhance cellular destruction. Temperatures of adjacent structures (urethra, bladder, rectum) were monitored throughout the procedure to avoid thermal injury. Patients were allocated to receive either a 14F Foley SPC or a 20F Foley UC in a nonrandomized manner based on the operating surgeon’s preference and clinical judgment, without predetermined allocation criterion. SPC placement was always performed under ultrasound guidance after bladder filling with sterile saline.

Patients were discharged on postoperative day 2 because of Italian reimbursement regulation. Those men receiving a UC were scheduled for a voiding trial on postoperative day 10. Patients with SPC were instructed to begin clamping the SPC and attempt voiding from postoperative day 10 and were reassessed on postoperative day 15 with UFM and ultrasound measurement of postvoiding residual of urine to remove the catheter. Follow-up was carried out by two dedicated urologists to ensure consistency in management and data collection.

Statistical analysis

The study outcomes included duration of catheterization, need for catheter reinsertion, and de novo urinary incontinence as well as complications requiring surgical intervention or genitourinary infections. Urinary incontinence was defined as any complaint of urine leakage according to patient reports.

Continuous variables are reported as median values and interquartile ranges (IQRs) and compared using the Mann–Whitney U test. Categorical variables are expressed as counts and percentages and compared using Fisher’s exact test. To identify independent predictors of postoperative urinary retention, we performed a multivariable logistic regression analysis with backward stepwise selection based on the Akaike Information Criterion. Variables were selected based on clinical relevance and included in the initial model, namely type of catheter (SPC vs UC), age, prostate volume, baseline IPSS, and PFR. Final results are reported as odds ratios (OR) with 95% confidence interval (CI) and corresponding p values. All tests were two-sided, and a p value <0.05 was considered statistically significant. All statistical analyses were performed using R statistical software 4.3.3 (R Foundation for Statistical Computing, Vienna, Austria).

Results

During the study period, a total of 67 patients underwent whole-gland cryoablation for organ-confined PCa at Bonomo Teaching Hospital, Andria, Italy. Overall, 52 were found to be eligible for the present analysis; specifically, 19 received a SPC and 33 a UC at the time of treatment. Preoperative patient characteristics are summarized in Table 1. No significant differences were observed between groups in terms of median age (77.9 vs 78.6 years, p = 0.497), serum prostate specific antigen (6.2 vs 8.2 ng/mL, p = 0.085), prostate volume (50 vs 45 cc, p = 0.154), PFR (13.0 vs 12.0 mL/s, p = 0.264), PVR (35.0 vs 40.0 mL, p = 0.172), and IPSS (13.0 in both groups, p = 0.668).

Table 1.

Preoperative Characteristics of Patients Receiving a Suprapubic Catheter or a Urethral Catheter After Whole-Gland Prostate Cryoablation

	All patients (n = 52)	SPC (n = 19)	UC (n = 33)	p Value
Age, y	78.1 [76.5–80.8]	77.9 [76.6–80.2]	78.6 [76.5–81.4]	0.497
Serum PSA, ng/mL	8.00 [5.7–10.5]	6.2 [5.3–9.4]	8.2 [6.4–12.5]	0.085
Prostate Volume, cc	47.5 [33.8–57.0]	50.0 [40.0–70.0]	45.0 [30.0–55.0]	0.154
PFR, mL/s	12.0 [10.0–14.0]	13.0 [11.0–14.5]	12.0 [8.0–14.0]	0.264
PVR, mL	37.0 [25.0–50.0]	35.00 [19.0–41.5]	40.0 [30.0–50.0]	0.172
IPSS	13.0 [7.8–16.2]	13.0 [6.5–15.5]	13.0 [8.0–17.0]	0.668

IPSS = International Prostate Symptoms Score; PFR = peak flow rate; PSA = prostate specific antigen; PVR = postvoid residual volume; SPC = suprapubic catheter; UC = urethral catheter.

Postoperative outcomes are summarized in Table 2. The median time to effective voiding trial was significantly longer in the SPC group compared with the UC group (50 vs 20 days, p = 0.022). Post-treatment urinary retention occurred in 23 patients (44.2%), with similar incidence in the SPC (42.1%) and UC groups (45.5%) (p = 0.99). Conservative management was effective in 15 patients (28.8%), more frequently in the UC group (36.4%) than in the SPC group (15.8%) (p = 0.203). Eight patients (15.4%) required transurethral procedure to relieve bladder outlet obstruction, with a nonsignificant trend toward higher frequency in the SPC group (26.3% vs 9.1%, p = 0.124).

Table 2.

Postoperative Urinary Outcomes of Patients Receiving a Suprapubic Catheter or a Urethral Catheter

	All patients (n = 52)	SPC (n = 19)	UC (n = 33)	p Value
Time to effective void trial (days), median (IQR)	20.0 (20.0–42.5)	50.0 (47.5–55.0)	20.0 (20.0–27.5)	0.022
Delayed urinary retention, n (%)	23 (44.2%)	8 (42.1%)	15 (45.5%)	0.99
Managed conservatively, n (%)	15 (28.8%)	3 (15.8%)	12 (36.4%)	0.203
Requiring transurethral surgery, n (%)	8 (15.4%)	5 (26.3%)	3 (9.1%)	0.124
Seminal tract infectious complications, n (%)	3 (5.8%)	3 (15.8%)	0 (0%)	0.044
Acute epididymitis	1 (1.9%)	1 (5.3%)	0 (0%)	0.365
Prostatic Abscess	2 (3.8%)	2^a (10.5%)	0 (0%)	0.129
Urinary tract infections, n (%)	3 (5.8%)	0 (0%)	3 (9.1%)	0.291
Complications requiring surgery, n (%)	9 (17.3%)	6 (31.6%)	3 (9.1%)	0.039
Urinary incontinence, n (%)	13 (25%)	5 (26.3%)	8 (24.2%)	0.99
Stress incontinence, n (%)	8 (15.4%)	4 (21.1%)	4 (12.1%)	0.443
Urge incontinence, n (%)	7 (14.3%)	2 (10.5%)	5 (15.2%)	0.99

One patient had sepsis and required surgical drainage.

Bold values stand for significant p value.

Seminal tract infectious complications occurred exclusively in the SPC group (15.8%, p = 0.044), including one case of acute epididymitis and two cases of prostatic abscess (one progressing to sepsis requiring surgical drainage). Urinary tract infections occurred in three patients (all in the UC group), whereas overall complications requiring surgical intervention were significantly more frequent in the SPC group (31.6% vs 9.1%, p = 0.039). De novo urinary incontinence was reported in 13 patients (25%) with no significant difference between groups (26.3% in SPC vs 24.2% in UC, p = 0.99). Rates of stress and urge incontinence were also comparable.

At 12-month follow-up, IPSS values were similar between the two groups. The median IPSS was 15.0 [IQR 12.5–22.0] overall, 19.5 [14.0–22.0] in the SPC group and 15.0 [12.0–18.0] in the UC group (p = 0.416).

The backward logistic regression analysis (Table 3) shows that no factors were significantly associated with higher odds of post-treatment urinary retention.

Table 3.

Backward Logistic Regression Model

	OR (95% CI)	p Value
SPC vs UC	0.82 (0.23–2.78)	0.74
Age	0.94 (0.83–1.04)	0.25
Prostate volume	1.00 (0.97–1.03)	0.90
IPSS	1.02 (0.93–1.13)	0.63
PFR	1.01 (0.88–1.14)	0.90

OR = odds ratio; 95% CI = 95% confidence interval.

Discussion

To our knowledge, this is the first prospective study comparing the SPC and the UC bladder drainage strategies in the setting of transperineal whole-gland cryoablation of the prostate for organ-confined PCa. We believe this study provides clinically relevant insights into voiding outcomes and complications associated with these two bladder drainage methods.

In terms of voiding outcomes, the SPC strategy was associated with a significantly longer median time to effective voiding trial (50 vs 20 days), and this undoubtedly affected patients’ satisfaction. Unfortunately, our study was designed to assess voiding outcomes and complications of the two bladder drainage strategies, and therefore, we did not plan to use questionnaires to address patient satisfaction and this is a study limitation. That said, the absence of a urinary bag and the possibility of home trial of voiding associated with the clamping and declamping of the SPC might be perceived as “less aggressive” and more “physiological” than the need of performing one or more in-hospital “trial without catheter” in the UC group. We indeed recommend not to clamp the UC to avoid potential negative effects.⁸

The different catheterization time between the two groups may be ascribable to the postcryoablation tissue edema and inflammation, which can transiently obstruct the prostatic urethra, elevate bladder outlet resistance, and impair detrusor function during the recovery phase.⁹ Transient urinary retention is known to be a common consequence of prostate cryotherapy, and Caso and colleagues have even proposed keeping the urethral warming catheter in place for several hours postprocedure to reduce the edema-related blockage.¹⁰ Our findings would suggest that the UC might better keep the prostatic urethra patency in the short term, and this turned into shortening of catheterization time compared with SPC. Although this finding was somehow expected, differences in the risk of undergoing transurethral operation were unexpected. Looking at the literature, Aus and associates did not compare the SPC and the UC bladder drainage strategies, but reported that the patients they treated with first-generation cryoablation needed a postoperative SPC for a mean of 18 days, and 15% eventually underwent transurethral operation to relieve prostatic obstruction.¹¹ Our study showed that the risk of urinary retention requiring transurethral procedure was lower in patients who received a UC compared with those who received a SPC, supporting the hypothesis that the UC may serve as a scaffold to keep urethral patency even in the long term after cryoablation. In line with our findings, Rabinowitz and coworkers,¹² who compared the SPC and the UC approach in the setting of resonance image-guided whole-gland transurethral cryoablation for PCa, found that the SPC approach was associated with significantly longer time to effective voiding trial and higher rate (21.1% vs 7.7%) of urinary retention requiring transurethral operation.

Placement of a SPC should theoretically reduce the risk of UC-related infectious complications. It was therefore again unexpected that in our study seminal tract infectious complications occurred only in patients with a SPC and in one case it was so serious to lead to sepsis and drainage. There are grounds to assume that although suprapubic catheterization bypasses the urethral flora, it might introduce distinct infection-related risks that may be more harmful in the presence of the tissue necrosis occurring after cryoablation.¹³ It is well known that indwelling catheters (including SPCs) are frequently colonized within days of positioning, and prolonged catheterization significantly increases the risk of catheter-associated urinary tract infections (CAUTIs).^14,15 However, Han and colleagues demonstrated that when postoperative catheterization exceeds 5 days, SPC may be associated with an 86% reduction in CAUTIs risk compared with urethral catheterization.¹⁶ None of our patients in the SPC group had symptomatic urinary tract infections. Conversely, the occurrence of seminal tract infections, which occurred only in the SPC group, points out that the UC might also have less impact on such complications, probably keeping a better urethral patency. Finally, the bladder drainage strategy had no impact on de novo urinary incontinence, a known complication because of the localized thermal injury that may disrupt sphincter integrity and impair neuromuscular control.¹⁷

Notably, our logistic regression model did not identify any independent predictor of postoperative urinary retention. Although clinically relevant variables such as age, prostate volume, IPSS, PFR, and type of bladder drainage were evaluated, none showed a statistically significant association with higher odds of urinary retention. This may reflect both the multifactorial nature of the condition and the limited power of our analysis because of the small number of events.

Several study limitations should be recognized. First, the small sample size may restrict the statistical power to identify significant differences across all outcomes, especially concerning less common events like infectious complications. Second, our patients’ allocation to the different bladder drainage strategies is a selection bias. Third, the study did not specifically address patients’ satisfaction with the two bladder drainage methods, but rather it was designed to assess voiding outcomes and potential complications. An additional limitation is that the clamping protocol used for the SPC group may have influenced our outcomes, and we cannot fully exclude its potential contribution to the observed differences. The UC likely functions as a mechanical scaffold maintaining prostatic urethral patency during the critical postcryoablation healing phase, an effect that cannot be replicated by a clamped SPC. In addition, the exclusive occurrence of seminal tract infections in the SPC group and the higher rate of transurethral procedure are unlikely to be solely explained by the clamping protocol, but rather to longer catheterization time and different patterns of bacterial colonization in the presence of postcryoablation tissue necrosis. Future studies should prospectively evaluate standardized clamping protocols for SPC to better isolate the impact of catheter type from management strategy, which may help optimize outcomes while preserving the potential comfort benefits of suprapubic drainage. Finally, the monocentric design might limit its generalizability, considering that practice patterns and postoperative protocols may differ among institutions.

Conclusion

In this study, we found that the SPC approach after cryoablation was not only associated with a significant longer time to catheter removal and higher rate of delayed urinary retention requiring transurethral operation but also to a significant higher rate of post-treatment seminal tract infectious complications. Such findings should be carefully balanced against the potential benefits of improving patients’ comfort using a SPC and underscore the need for developing risk-stratification tools to optimize the choice of the bladder drainage strategy after prostate cryoablation.

Authors’ Contributions

Conceptualization: L.C. Methodology: A.C., R.A.F., and L.C. Formal analysis: A.C. and R.A.F. Investigation: R.A.F., D.D.P., N.A.D.M., G.S., F.S., and A.D. Writing—original draft: A.C., R.A.F., D.C., and L.C. Writing—review and editing: A.C., D.C., A.M., and L.C. Visualization: A.C. and D.C. Supervision: T.K., G.C., and L.C. All authors approved of the final version of the article for submission.

Footnotes

Author Disclosure Statement

T.K. is a paid consultant/advisor of Astellas, Bayer, Janssen, and Sanofi. The other authors declare no conflicts of interest associated with this article.

Funding Information

The authors did not receive support from any organization for the submitted work.

Data Availability

Data are available on request from the corresponding author.

Ethics Declaration

This study was approved by the institutional review board (DICUNT 02/2021).

Abbreviations

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