Abstract
Background
To evaluate whether intermittent catheterization for bladder training can reduce urinary catheterization duration in patients undergoing mid-low rectal cancer surgery.
Methods
Stratified by gender, 330 patients were divided into a 5-day catheterization control group, and experimental groups A (3-day bladder training) and B (5-day bladder training), with 110 patients each.
Results
Two-way ANOVA found that gender affected recatheterization, Pdet@Qmax, Qmax, BOOI and three-day total urine volume. No difference between groups A and B. Patients in experimental group A had a shorter time to first void (P = 0.030) and lower three-day average residual urine volume (P = 0.011) than the control group, and patients in experimental group B had a larger urine volume (P = 0.043) and lower first residual urine volume (P = 0.001). Bladder training reduced recatheterization in males. The nomogram constructed based on the logistic regression model better predicted the risk of urinary tract infection (AUC = 0.669) and recatheterization (AUC = 0.731). These two models may help provide new tools for the postoperative care of patients with mid-low rectal cancer.
Conclusions
Three-day catheter removal after bladder training is non-inferior to five-day removal. Bladder training is effective in reducing the chances of recatheterization in patients with mid-low rectal cancer.
Trial registration
This study was registered with the China Clinical Trials Registry at 22th March, 2018 (No. ChiCTR1800015313, https://www.chictr.org.cn/showproj.html?proj=26123).
Supplementary Information
The online version contains supplementary material available at 10.1186/s12957-025-03991-z.
Keywords: Bladder training, Early removal of urinary catheter, Mid-low rectal cancer, Randomized controlled trial, Urinary dysfunction
Background
According to the latest GLOBOCAN data of the International Agency for Research on Cancer (IARC), as many as 732 million cases of rectal cancer were reported worldwide in 2020, including approximately 315 million cases in East Asia [1]. Mid-low rectal cancer is defined as rectal cancer where the distal end of the tumor is within 3–10 cm of the anal verge and is the most common type of rectal cancer. Total mesorectal excision (TME) has become the “gold standard” of surgery for mid-low rectal cancer, and based on the results of clinical trials such as COLORII and COREAN, laparoscopic TME has become the recommended procedure in clinical guidelines [2–5]. According to the Chinese colorectal cancer case registry database, 57.9% of rectal cancer surgeries were performed in China, of which 92.8% were for mid-low rectal cancer [6–9]. As the lower and middle rectum is in the deepest part of the pelvic cavity and has very complex organ and nerve adjacencies, there is a substantially increased risk of intraoperative damage to the pelvic floor structures in patients with mid-low rectal cancer, which further leads to a tendency to develop urinary dysfunction after surgery [10, 11].
Urinary dysfunction is often manifested by urinary retention, painful urination and urinary tract infections (UTIs), which can lead to renal impairment and can be life-threatening in severe cases [12]. This can affect the quality of life of patients with rectal cancer and add to the psychological burden and financial stress of patients. Postoperative urinary catheterization has become a routine means of preventing urinary retention, but prolonged retention not only delays the recovery of urinary function but also delays the patient’s ability to get out of bed after rectal cancer surgery, ultimately leading to an increased length of hospital stay and delaying the enhanced recovery process [13, 14]. With the development of enhanced recovery after surgery (ERAS), many scholars have proposed the new idea for early removal of urinary catheters after surgery. Although early postoperative removal of the urinary catheter reduces the risk for UTIs, this approach increases the incidence of urinary retention [14–16]. Bladder training by intermittent clamping of the urinary catheter has been shown to facilitate recovery of the detrusor muscle and may compensate for the risk of urinary retention associated with early removal of the urinary catheter [17–19]. This study was designed as a gender-stratified randomized controlled trial with two experimental groups: early removal of the urinary catheter (for 3 days) combined with intermittent catheterization for bladder training and regular urinary catheter for 5 days combined with bladder training, with regular urinary catheterization for 5 days and no bladder training as a positive control group. The aim is to observe the effectiveness of postoperative bladder training in patients with mid-low rectal cancer, primarily to verify the feasibility of early removal of the urinary catheter after bladder training.
Materials and methods
Study design
This is a single-center, prospective, randomized, open-label, blinded-endpoint, three-arm trial comparing the feasibility of bladder training through intermittent catheterization combined with early removal of the urinary catheter (for 3 days) in patients with mid-low rectal cancer, using regular urinary catheterization for 5 days as the positive control (shown in Fig. 1). The study was approved by the Ethics Committee of the Shandong Provincial Hospital affiliated with Shandong First Medical University (No. 2017545), and individual patient written informed consent was also obtained. This study was registered with the China Clinical Trials Registry (No. ChiCTR1800015313).
Fig. 1.
Overall design and workflow of this study
Study population
Potential participants were identified from patients with rectal cancer attending the Department of Gastrointestinal Surgery at the Shandong Provincial Hospital affiliated to Shandong First Medical University between April 2019 and April 2020. The inclusion criteria were as follows: [1] pathologically confirmed tumor that was 10 cm or less from the dentate line; [2] age of 18 years or older and signed informed consent; [3] American Society of Anesthesiology (ASA) score below IV and Eastern Cooperative Oncology Group (ECOG) score less than or equal to 1; [4] a solitary tumor without distant metastases, lymphatic metastases or extensive infiltration; and [5] amenable to laparoscopic radical rectal cancer surgery. The exclusion criteria were as follows: [1] concomitant diabetes mellitus; [2] combined urinary tumors, congenital malformations of the urinary system, severe benign prostatic hyperplasia, chronic urinary tract infections, renal failure, neurogenic bladder, hypertensive nephropathy, and other urinary dysfunction; [3] intermittent or prolonged preoperative indwelling of the urinary catheter; and [4] long-term nephrotoxic drugs or diuretics. Among those excluded under exclusion criterion [2], several patients were identified not only from their medical histories but also from the International Prostate Symptom Score (IPSS) and Quality-of-Life (QOL) score that were mandatory on admission, and any individual whose IPSS was below 20 and whose QOL score was below 4 was retained in the study. The sample size was estimated based on the reported incidence of urinary dysfunction in patients after 3- or 5-day catheter removal is 14% or 38% [20–22], calculated according to the formula (
), set at Δ = 0, δ = 14.5%, α = 0.05 and β = 0.1, plus a 10% missed visit rate; finally, 110 patients were determined to be included in each group.
Grouping, randomization and blinding
In this study, patients with mid-low rectal cancer were treated with regular urinary catheterization for 5 days postoperatively as the control group; experimental group A was treated with urinary catheterization for 3 days postoperatively and bladder training with intermittent clamping during this period; and experimental group B was treated with urinary catheterization for 5 days postoperatively while bladder training was performed. The process of bladder training involved opening the catheter for 5 min after 3 h, which was performed by the nursing team and the trained patient family. Stratified 1:1 randomization was performed based on gender, with a 1:1:1 completely random allocation of samples among the 3 groups within the stratum. A stratified randomization design form was produced by the department secretary; specifically, the patient identity document (patient ID) was determined by the order of consultation within the gender stratification, each patient ID corresponded to a random number, and the random numbers were arranged in ascending order to determine the group (shown in Table S1). The random numbers were generated by a random number generator in Microsoft Excel, set to a random number seed of 1234 and integers in the range of 1-500. The grouping and processing methods were not blinded to the trial designer, patients, data recorder and department secretary, but the final data were collated, and patient information and group information were withheld by the department secretary from the statistician for data analysis.
Evaluation indicators and data collection
Recatheterization due to acute postoperative urinary retention was considered the primary outcome, defined as an inability to completely drain the bladder despite a strong desire to urinate and a residual urine volume of more than 400 ml, as well as unavoidable catheter reinsertion. Urinary tract infection was diagnosed and treated as a secondary outcome based on symptoms of pain, urinary urgency, urinary frequency, and positive laboratory tests (including the clean-catch midstream technique for urine routine and urine culture). In addition to baseline patient data, procedure-related data, such as admission IPSS and QOL scores, and any previous or current medications for benign prostatic hyperplasia or overactive bladder (BPH/OAB), the duration of surgery, duration of anesthesia, patient-controlled analgesia (PCA), and intraoperative blood loss (≥ 1500 ml), were also collected. The medications for treating BPH/OAB that we documented include alpha-blockers, 5-alpha-reductase inhibitors, anticholinergics, and beta-3 agonists. The maximum urine flow rate (Qmax), detrusor pressure at the maximum urine flow rate (Pdet@Qmax), bladder outflow obstruction index (BOOI), time to first void (TFV), first urine volume (FUV), first residual urine volume (FRUV), three-day total urine volume (three-day TUV), three-day total number of urination (three-day TNU), three-day average urine volume (three-day AUV), three-day average residual urine volume (three-day ARUV) and hospital stay were also recorded.
Statistical analysis
Statistical analyses were performed using SPSS 26.0, and the Kolmogorov‒Smirnov test was used to evaluate whether the data conformed to a normal distribution. Measures conforming to a normal distribution are expressed as the mean ± standard deviation; otherwise, they are expressed as the median (25–75% quartiles). T tests, rank sum tests and analysis of variance (ANOVA) were used to calculate differences between groups. Count data are expressed as percentages, and the chi-square test or Fisher’s exact test was used for analysis. Two-way ANOVA was used to test the effect between gender stratification and observed indicators. Multifactor logistic regression analysis was used to construct the risk model, which was evaluated with a receiver operating characteristic (ROC) curve. A two-sided P < 0.05 was considered to indicate a statistically significant difference.
Results
Patient access and comparison of intergroup data
On the basis of 1:1:1 gender stratification, a total of 330 patients were admitted by the department secretary according to the established stratified randomization design table and inclusion/exclusion criteria; 110 of these patients were in the control group, 110 were in experimental group A, and 110 were in experimental group B. The general medical history data of the patients in the three groups are shown in Table 1. There were no significant intergroup differences in the basic preoperative characteristics, admission IPSS and QOL scores, and any past or current medications for BPH/OAB, surgical methods, and basic intraoperative characteristics among the patients in the three groups, which is in line with the original design of this study.
Table 1.
Information on the underlying characteristics of the samples
| Control group | Experimental group A | Experimental group B | Statistics | P value | |
|---|---|---|---|---|---|
| Age | 56.5(50–66) | 55(48–62) | 57.5(49–66) | 3.336* | 0.189 |
| Smoking | 21(19.1%) | 20(18.2%) | 29(26.4%) | 2.647† | 0.266 |
| Drinking | 28(25.5%) | 28(25.5%) | 34(30.9%) | 1.100† | 0.577 |
| Hypertension | 2(1.8%) | 4(3.6%) | 5(4.5%) | 1.317† | 0.518 |
| Coronary heart disease | 1(0.9%) | 1(0.9%) | 4(3.6%) | 3.056† | 0.217 |
| Cerebralinfarction | 0(0%) | 1(0.9%) | 1(0.9%) | 1.006† | 0.605 |
| Neoadjuvant therapy | 12(10.9%) | 11(10.0%) | 18(16.4%) | 2.395† | 0.302 |
| Weight | 66.15(59.1-72.925) | 64.1(55.925–71.85) | 67.75(59.7-74.075) | 5.529* | 0.063 |
| Height | 165.5(158–171) | 167(157.25-172.75) | 170.5(157.25–176) | 3.744* | 0.154 |
| Body mass index | 24.31(21.25–27.30) | 22.90(20.28–26.52) | 23.7(20.86–26.58) | 1.978* | 0.372 |
| ECOG score | 0.752‡ | 0.386 | |||
| 0 | 19(17.3%) | 18(16.4%) | 24(21.8%) | ||
| 1 | 91(82.7%) | 92(83.6%) | 86(78.2%) | ||
| ASA score | 0.953‡ | 0.329 | |||
| I | 32(29.1%) | 24(21.8%) | 20(18.2%) | ||
| II | 49(44.5%) | 61(55.5%) | 63(57.3%) | ||
| III | 29(26.4%) | 25(22.7%) | 27(24.5%) | ||
| IPSS | 7(4–11) | 8(5–11) | 8(5–12) | 0.018* | 0.991 |
| QOL score | 0.287‡ | 0.592 | |||
| 0 | 30(27.3%) | 38(34.5%) | 30(27.3%) | ||
| 1 | 47(42.7%) | 41(37.3%) | 42(38.2%) | ||
| 2 | 26(23.6%) | 28(25.5%) | 29(26.4%) | ||
| 3 | 7(6.4%) | 3(2.7%) | 9(8.2%) | ||
| Previous or current use of BPH/OAB medications | 27(24.5%) | 38(34.5%) | 31(28.2%) | 2.732† | 0.255 |
| Tumor size | 7(5–10) | 9(6-10.75) | 8(5–10) | 5.719* | 0.057 |
| Surgical method | 2.301† | 0.681 | |||
| Dixon | 68(61.8%) | 62(56.4%) | 70(63.6%) | ||
| Miles | 31(28.2%) | 34(30.9%) | 32(29.1%) | ||
| Hartmann | 11(10.0%) | 14(12.7%) | 8(7.3%) | ||
| Duration of surgery (min) | 92(78.25-103.75) | 91.5(78–103) | 93(76-108.75) | 0.693* | 0.707 |
| Duration of anesthesia (min) | 66(51–78) | 64(51.25–76.75) | 69.5(50–80) | 0.684* | 0.710 |
| Patient-controlled analgesia | 91(82.7%) | 82(74.5%) | 81(73.6%) | 3.111† | 0.211 |
| Intraoperative blood loss(>1500 ml) | 18(16.4%) | 16(14.5%) | 16(14.5%) | 0.189† | 0.910 |
* Independent-Sample Kruskal-Wallis Test
† Chi-Square Test for Pearson Chi-Square
‡ Chi-Square Test for Linear-by-Linear Association
Two-way ANOVA was used to evaluate the interaction of gender with primary/secondary outcomes, urodynamic data and hospital stays postoperatively and found that gender affected recatheterization, Pdet@Qmax, Qmax, BOOI and three-day TUV (shown in Table 2). There was variability in recatheterization among the three groups (P = 0.043), but this may have been caused by gender. In contrast, the differences in FRUV (P = 0.005) and three-day ARUV (P = 0.036) among the three groups were not related to gender and required a two-by-two intergroup analysis. Further analysis revealed that there were no differences between experimental group A and experimental group B for any of the observed indicators. That is, 3-day removal of the urinary catheter was not inferior to 5-day removal of the urinary catheter, provided that the patients underwent bladder training. In contrast, the low recatheterization rate (P = 0.031) and high Qmax (P = 0.047) of patients in experimental group A compared to those in the control group was perhaps mainly due to the effect of gender and requires a gender-stratified reanalysis. More often, patients in experimental group A had a lower TFV (P = 0.030) and a lower three-day ARUV (P = 0.011) than those in the control group. Compared to the control group, patients in experimental group B had a higher FUV (P = 0.043) and lower FRUV (P = 0.001).
Table 2.
Analysis of the interaction between gender and primary/secondary outcomes
| Control group | Experimental group A | Experimental group B | Gender | Total | Experimental group A vs. Experimental group B | Control group vs. Experimental group A | Control group vs. Experimental group B | |
|---|---|---|---|---|---|---|---|---|
| Statistics* (P value) | Statistics (P value) | Statistics (P value) | Statistics (P value) | Statistics (P value) | ||||
| UTI | 21(19.1%) | 20(18.2%) | 17(15.5%) | 0.332(0.565) | 0.544†(0.762) | 0.292†(0.589) | 0.030†(0.863) | 0.509†(0.476) |
| Re-catheterization | 17(15.5%) | 7(6.4%) | 8(7.3%) | 5.097(0.025) | 6.298†(0.043) | −0.072†(0.789) | 4.677†(0.031) | 3.655†(0.056) |
| Pdet@Qmax | 48(38–55) | 50(37.25–57.75) | 46(36–56) | 13.429(< 0.001) | 2.793‡(0.247) | 1.529§(0.126) | −1.350§(0.177) | 0.155§(0.877) |
| Qmax | 12(8–16) | 13(9.25-18) | 13(9–18) | 78.349(< 0.001) | 4.394‡(0.111) | 0.499§(0.618) | −1.991§(0.047) | −1.540§(0.124) |
| BOOI | 21(12.25–28.75) | 22.5(12.5–28) | 20(8.25–26.75) | 10.363(0.001) | 3.837‡(0.147) | 1.828§(0.068) | −0.177§(0.86) | 1.542§(0.123) |
| TFV | 229.5(151.5-280.75) | 192(127.5-249.75) | 213.5(124–269) | 1.456(0.228) | 4.480‡(0.106) | −0.956§(0.339) | 2.165§(0.03) | 1.056§(0.291) |
| FUV | 200(130–260) | 230(160–290) | 235(152.5–310) | 0.026(0.873) | 5.099‡(0.078) | −0.262§(0.794) | −1.864§(0.062) | −2.024§(0.043) |
| FRUV | 80(50–120) | 70(32.5–100) | 60(40–80) | 0.442(0.506) | 10.697‡(0.005) | 1.555§(0.12) | 1.829§(0.067) | 3.208§(0.001) |
| Three-day TUV | 2152(1905.75-2596.5) | 2211.5(1972.25-2483.5) | 2360.5(1959.5-2612.25) | 7.847(0.005) | 1.080‡(0.583) | −1.105§(0.269) | −0.085§(0.932) | −0.688§(0.491) |
| Three-day TNU | 8(6.25-9) | 8(6–10) | 8(6.25-9) | 0.012(0.914) | 0.910‡(0.635) | 0.879§ 0.379) | −0.760§(0.447) | 0.109§(0.913) |
| Three-day AUV | 290(242.5–370) | 280(220–370) | 290(250–350) | 3.833(0.051) | 0.916‡(0.633) | −0.978§(0.328) | 0.651§(0.515) | −0.095§(0.924) |
| Three-day ARUV | 75(50–100) | 60(30–90) | 70(40–100) | 1.183(0.278) | 6.631‡(0.036) | −1.542§(0.123) | 2.536§(0.011) | 1.061§(0.289) |
| Postoperative hospital stay | 9(7–11) | 9(7–11) | 9(7-11.25) | 0.645(0.423) | 0.407‡(0.816) | −0.598§(0.55) | −0.035§(0.972) | −0.506§(0.613) |
* Two Way ANOVA Test
† Chi-Square Test
‡ Independent-Sample Kruskal-Wallis Test
§ Mann-Whitney U Test
Differential variation in urinary-related indicators by gender
After stratifying the data by gender, an analysis of differences in recatheterization, Pdet@Qmax, Qmax, BOOI and three-day TUV, for which the main effect was from gender, found (shown in Tables 3 and 4) that among male patients, there was no difference in the rates of recatheterization between patients in experimental group A and experimental group B (P = 0.728), while patients in the control group had a higher rate of recatheterization than those in both experimental group A and B (control group vs. experimental group A: P = 0.018, control group vs. experimental group B: P = 0.039). This demonstrates that bladder training is effective in reducing the chances that patients need to be recatheterized postoperatively and implies that early removal of the urinary catheter combined with bladder training is highly feasible. There was a higher Qmax in patients in experimental group B than in those in the control group, but this was within the normal range in terms of the median being 12; after all, it took a Qmax of less than 10 to suspect that the patient had a urinary tract obstruction. In terms of three-day TUV, patients in experimental group B had a lower volume than those in experimental group A (P < 0.001) and those in the control group (P = 0.001). Among female patients, Pdet@Qmax was higher in patients from experimental group A than in patients from experimental group B (P = 0.035), and the three-day TUV was higher in patients from experimental group B than in patients from either other group (experimental group A vs. experimental group B: P < 0.001, control group vs. experimental group B: P < 0.001).
Table 3.
There were between-group differences in outcomes under gender stratification in male
| Control group | Experimental group A | Experimental group B | Experimental group A vs. Experimental group B | Control group vs. Experimental group A | Control group vs. Experimental group B | Total | |
|---|---|---|---|---|---|---|---|
| Statistics(P value) | Statistics(P value) | Statistics(P value) | Statistics(P value) | ||||
| Re-catheterization | 13(23.6%) | 4(7.3%) | 5(9.1%) | −0.121*(0.728) | 5.636*(0.018) | 4.251*(0.039) | 7.657*(0.022) |
| Pdet@Qmax | 45(37.5–53) | 46(37-53.5) | 44(36.5–55) | 0.063†(0.950) | −0.176†(0.860) | 0.218†(0.827) | 0.053‡(0.974) |
| Qmax | 10(6-13.5) | 11(8-14.5) | 12(8–16) | −0.750†(0.453) | −1.526†(0.127) | −2.047†(0.041) | 4.722‡(0.094) |
| BOOI | 24(16–31) | 23(18.5–27) | 21(15–27) | 1.057†(0.291) | 0.347†(0.729) | 1.221†(0.222) | 1.815‡(0.403) |
| Three-day TUV | 2274(1939–2585) | 2290(2033-2669.5) | 1952(1699.5–2258) | 4.050†(< 0.001) | −0.714†(0.475) | 3.351†(0.001) | 18.818‡(< 0.001) |
* Chi-Square Test
† Mann-Whitney U Test
‡ Independent-Sample Kruskal-Wallis Test
Table 4.
There were between-group differences in outcomes under gender stratification in female
| Control group | Experimental group A | Experimental group B | Experimental group A vs. Experimental group B | Control group vs. Experimental group A | Control group vs. Experimental group B | Total | |
|---|---|---|---|---|---|---|---|
| Statistics(P value) | Statistics(P value) | Statistics(P value) | Statistics(P value) | ||||
| Re-catheterization | 4(7.3%) | 3(5.5%) | 3(5.5%) | < 0.001*(1.000) | 0.153*(0.696) | 0.153*(0.696) | 0.213*(0.899) |
| Pdet@Qmax | 49(38–56) | 54(45.5–63.5) | 49(35–56) | 2.108†(0.035) | −1.666†(0.096) | 0.473†(0.637) | 4.976‡(0.083) |
| Qmax | 15(10-19.5) | 18(12–21) | 17(10–20) | 1.399†(0.162) | −1.794†(0.073) | −0.351†(0.726) | 3.542‡(0.170) |
| BOOI | 16(10–28) | 21(10-28.5) | 15(7–24) | 1.406†(0.160) | −0.455†(0.649) | 1.056†(0.291) | 2.202‡(0.332) |
| Three-day TUV | 2125(1868-2599.5) | 2162(1948-2351.5) | 2560(2384–2710) | −6.364†(< 0.001) | 0.457†(0.647) | −3.838†(< 0.001) | 36.116‡(< 0.001) |
* Chi-Square Test
† Mann-Whitney U Test
‡ Independent-Sample Kruskal-Wallis Test
Construction of the nomogram for predicting the risk of urinary tract infection and recatheterization
A further causal analysis of UTI and recatheterization revealed that UTI was associated with recatheterization (P = 0.002), ASA score (P = 0.020), BOOI (P = 0.025) and three-day TNU (P = 0.036, shown in Table S2). A higher ASA score (P = 0.019) and a high three-day TNU (P = 0.025) were perhaps independent risk factors for UTI (Table S3). In contrast, the risk of patient recatheterization was strongly associated with sex (P = 0.026), history of alcohol consumption (P = 0.028), PCA (P = 0.018), UTI (P = 0.002), Pdet@Qmax (P < 0.001), Qmax (P < 0.001), and BOOI (P < 0.001, Table S4). Considering that all three urodynamic parameters, Pdet@Qmax, Qmax and BOOI, are diagnostic criteria in current use to suggest urethral obstruction, as well as the fact that patients with urethral obstruction must have a urinary catheter inserted, a multifactorial risk analysis was performed after their exclusion. The results showed that UTI and PCA were independent risk factors for recatheterization (Table S5). Based on the logistic regression risk model, we successfully constructed a nomogram for predicting the risk of UTI (Fig. 2A), which was tested with a ROC curve and found to have an area under the curve (AUC) of 0.669, a sensitivity of 58.6% and a specificity of 71.7% (Fig. 2B). We also successfully constructed a nomogram for predicting the risk of recatheterization (Fig. 2C), with the ROC curve showing an AUC of 0.731, a sensitivity of 65.6% and a specificity of 71.5% (Fig. 2D). These two models may help provide new tools for the postoperative care of patients with mid-low rectal cancer.
Fig. 2.
Risk prediction model for urinary tract infection and recatheterization. A The nomogram for predicting the risk of UTI. B ROC curve of the nomogram for predicting the risk of UTI. C The nomogram for predicting the risk of recatheterization. D ROC curve for the nomogram for predicting the risk of recatheterization
Discussion
According to GLOBOCAN 2020, colorectal cancer has the third highest incidence among malignancies worldwide [1]. In China, the latest statistics show that the number of colorectal cancer cases reached 376 thousand [6–9]. Surgery is considered one of the main causes of postoperative bladder emptying dysfunction in patients with rectal cancer [20, 23, 24]. In addition, postoperative tension, local wound pain and altered bladder position can also contribute to postoperative urinary retention, which is one of the most common harmful effects of rectal cancer surgery [25–29]. Postoperative bladder dysfunction may require recatheterization, which greatly reduces the patient’s quality of life and increases the chance of infection. Intermittent clamping of the urinary catheter for bladder training is frequently applied in patients with mid-low rectal cancer [15, 20, 25, 29]. ERAS has been shown to reduce postoperative complications and hospital stays in patients undergoing elective surgery. To investigate whether intermittent clamping of the urinary catheter improves bladder function, we conducted this prospective blinded-endpoint randomized controlled trial. Patients from experimental group A, experimental group B and the control group had similar basic clinical characteristics, which further demonstrated that there were no differences in the degree of bladder damage among the three groups due to the different treatment procedures. Because of the differences in male and female urethral anatomy, gender stratification was necessary to assess the effect of intermittent clamping of the urinary catheter on bladder function restoration. The results of two-way ANOVA confirmed that gender does influence recatheterization, Pdet@Qmax, Qmax, BOOI and three-day TUV. Pdet@Qmax, Qmax and BOOI are urodynamic indicators that allow for a more accurate assessment of bladder function and are important for diagnosing the severity of a patient’s bladder outlet obstruction; these parameters also represent the most important methods of determining whether a patient needs surgery to relieve urethral obstruction [30]. The interaction that exists between urodynamic parameters and gender is clearly an inherent effect of physiological nature; however, this did not cause a significant difference among the three groups. Nonetheless, the risk of recatheterization was influenced by gender, with male patients benefiting from bladder training, even with early removal of the urinary catheter. Female patients, on the other hand, did not show a significant benefit from recatheterization in bladder training and/or early removal of the urinary catheter, although this approach also did not produce inferior outcomes to conventional catheterization. This phenomenon suggests that postoperative bladder training in patients with mid-low rectal cancer facilitates early removal of the urinary catheter, especially in male patients.
Bladder residual urine volume is a relatively convenient and inexpensive noninvasive screening parameter, and although less accurate than urodynamic parameters such as Qmax, Pdet@Qmax and BOOI in predicting urethral obstruction, it is more widely used in primary and secondary care settings [31]. Patients in experimental group B had lower first residual urine volumes than those in the control group, perhaps a manifestation of patients adapting to intermittent clamping of the urinary catheter. Similarly, patients in experimental group A had lower three-day average residual urine volumes than patients in the control group. Our team speculates that this may be because intermittent catheterization facilitates recovery of bladder function, particularly in terms of residual urine volume, which makes it less likely for male patients to be recatheterized. The finding that there was no change in residual urine volume in female patients as a result of bladder training is consistent with the findings of He et al. [32] This may be related to the relative difficulty women have with holding urine due to their straighter and shorter urethras. Some studies have shown that bladder training over 6–8 weeks is effective in improving voiding in women [33, 34], and our study was limited to the period before patients were discharged from the hospital, which may explain the lack of reduction in the rate of recatheterization in female patients in experimental group A and experimental group B. Male patients in experimental group B had a slightly higher Qmax than those in the control group, but overall, the risk of recatheterization was reduced. Female patients in experimental group B had a slightly higher Pdet@Qmax than those in experimental group A. This also did not cause an increased chance of recatheterization or urinary tract infection. These results suggest that a single urodynamic parameter may not be sufficient to evaluate voiding and that a relatively comprehensive system for evaluating the risk of recatheterization and urinary tract infection in patients with mid-low rectal cancer using more indicators is necessary.
There are some limitations in the study, although the high specificities of the two risk prediction models for urinary tract infection and recatheterization that we developed offers new tools with a much lower chance of misdiagnosis and can effectively reduce healthcare resource waste, especially reducing the workload of nurses. The slightly lower sensitivity may be related to the relatively small number of patients included, and a prospective multicenter trial in our joint facilities is urgently needed. As a pragmatic single-centre RCT focused on early catheter removal after rectal-cancer surgery, we did not systematically obtain pre-operative uroflowmetry (Qmax, Pdet@Qmax, BOOI) or trans-rectal-ultrasound prostate-volume measurements. Consequently, mild baseline differences in voiding function may not have been fully excluded. Future multi-centre trials should standardise pre-operative uroflowmetry and prostate-volume assessment to corroborate our findings. The mandatory nursing IPSS and QOL questionnaires were used only to exclude patients with marked symptoms (IPSS ≥ 20 or QOL ≥ 4), and cannot substitute for objective urodynamic indices. Therefore, individuals with mild lower urinary tract symptoms who were nevertheless on long-term α-blockers, 5-α-reductase inhibitors, antimuscarinics or β3-agonists could still have been enrolled, representing a potential confounder. However, baseline medication histories were balanced across the three groups, suggesting a Limited impact on the primary outcomes. Although we later retrieved information on 4 types of BPH/OAB medications, records of β-blockers, calcium-channel blockers, tricyclic antidepressants, antihistamines, opioids and PDE-5 inhibitors were not prospectively captured; these agents can independently affect detrusor contractility or outlet resistance and thus constitute residual confounders. Finally, our discussion centred on recent ERAS and uro-oncology literature and did not extensively contrast findings with urogynaecological, orthopaedic or gynaecological trials that report conflicting clamping efficacy, nor with health-economic analyses of early catheter removal; these omissions restrict the breadth of contextual interpretation. Multi-centre studies incorporating pre-operative urodynamic assessment, rigorous medication reconciliation, longer follow-up, cost-effectiveness analyses and external validation across diverse surgical populations will be needed to overcome these limitations. Overall, it remains controversial whether intermittent clamping of the urinary catheter for bladder training is useful for postoperative bladder function recovery. Fun et al. noted that bladder training after transurethral resection of the prostate had a significant positive effect on patients’ urinary storage symptoms [35]. However, Markopoulos et al. prospectively evaluated 218 individuals who underwent total hip and knee arthroplasty and found no advantage of bladder training over free drainage with the catheter [36]. In addition, the presence of accompanying families may be unique to China. Although part of bladder training performed by trained families can reduce the work of the medical team, this may not be globally applicable. Moreover, the training cost varies according to the learning ability of the family members. In conclusion, in this study, we confirmed that intermittent catheterization and/or early removal of the urinary catheter did not cause an increased risk of urinary tract infection and was effective in reducing the chance of recatheterization in men with mid-low rectal cancer. Intermittent catheterization facilitates the recovery of bladder function in male patients and does not adversely affect female patients. In both men and women with mid-low rectal cancer, postoperative intermittent catheterization for bladder training allows for earlier removal of the urinary catheter, which is beneficial to the care of the urinary catheter.
Conclusion
In male patients with mid-low rectal cancer, bladder training by intermittent clamping of the urinary catheter may assist in the recovery of bladder function after surgery. The application of bladder training in both men and women is effective in reducing the urinary catheterization time of patients, which meets the ERAS criteria. Furthermore, bladder training can be performed safely and effectively, as there was no increased risk of urinary tract infection or recatheterization. Therefore, there is a need to routinely perform bladder training in patients with mid-low rectal cancer in the postoperative period.
Supplementary Information
Acknowledgements
Not applicable.
Abbreviations
- TME
Total mesorectal excision
- UTIs
Urinary tract infections
- ECOG
Eastern Cooperative Oncology Group
- PCA
Patient-controlled analgesia
- Qmax
The maximum urine flow rate
- Pdet@Qmax
Detrusor pressure at the maximum urine flow rate
- BOOI
Bladder outflow obstruction index
- TFV
Time to first void
- FUV
First urine volume
- FRUV
First residual urine volume
- three-day TUV
Three-day total urine volume
- three-day TNU
Three-day total number of urination
- three-day AUV
Three-day average urine volume
- three-day ARUV
Three-day average residual urine volume
- ANOVA
Analysis of variance
- ROC curve
Receiver operating characteristic curve
- ERAS
Enhanced recovery after surgery
Authors’ contributions
YSW and XZ analyzed and interpreted the patient data. YZC and JZZ performed the surgery and related operations, patient management, and were major contributors in writing the manuscript. All authors read and approved the final manuscript.
Funding
This work was supported by the Natural Science Foundation of Shandong Province in China (ZR2022MH070) and Natural Science Foundation of Shandong Province in China (ZR2022MH085).
Data availability
The data that support the findings of this study are openly available in Chinese Clinical Trial Registry at https://www.chictr.org.cn/index.html, reference number ChiCTR1800015313.
Declarations
Ethics approval and consent to participate
This study was approved by the Ethics Committee of Shandong Provincial Hospital affiliated with Shandong First Medical University (Ethics No: 2017545) on January 11, 2018. This research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki. All participants provided written informed consent prior to enrolment in the study.
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The data that support the findings of this study are openly available in Chinese Clinical Trial Registry at https://www.chictr.org.cn/index.html, reference number ChiCTR1800015313.