Evaluating the effectiveness of early urethral catheter removal combined with intermittent catheterization for promoting early recovery of bladder function after laparoscopic radical hysterectomy: a study protocol for a randomized controlled trial.
Bladder dysfunction, notably urinary retention, emerges as a significant complication for cervical cancer patients following radical hysterectomy, predominantly due to nerve damage, severely impacting their postoperative quality of life. The challenges to recovery include insufficient pelvic floor muscle training and the negative effects of prolonged postoperative indwelling urinary catheters. Intermittent catheterization represents the gold standard for neurogenic bladder management, facilitating bladder training, which is an important behavioral therapy aiming to enhance bladder function through the training of the external urethral sphincter and promoting the recovery of the micturition reflex. Nevertheless, gaps remain in current research regarding optimal timing for intermittent catheterization and the evaluation of subjective symptoms of bladder dysfunction.
Cervical cancer patients undergoing laparoscopic radical hysterectomy will be recruited to this randomized controlled trial. Participants will be randomly assigned to either early postoperative catheter removal combined with intermittent catheterization group or a control group receiving standard care with indwelling urinary catheters. All these patients will be followed for 3 months after surgery. The study's primary endpoint is the comparison of bladder function recovery rates (defined as achieving a Bladder Function Recovery Grade of II or higher) 2 weeks post-surgery. Secondary endpoints include the incidence of urinary tract infections, and changes in urodynamic parameters, and Mesure Du Handicap Urinaire scores within 1 month postoperatively. All analysis will adhere to the intention-to-treat principle.
The findings from this trial are expected to refine clinical management strategies for enhancing postoperative recovery among cervical cancer patients undergoing radical hysterectomy. By providing robust evidence, this study aims to support patients and their families in informed decision-making regarding postoperative bladder management, potentially reducing the incidence of urinary complications and improving overall quality of life post-surgery.
ChiCTR2200064041, registered on 24th September, 2022.
Chen Y
，Li L
，Shi Y
，Rong X
，Wang Y
，Wu J
，Liang X
，Wu Z
... -
《Trials》
Postoperative interventions for preventing bladder dysfunction after radical hysterectomy in women with early-stage cervical cancer.
Bladder dysfunction is a common complication following radical hysterectomy, caused by the damage to pelvic autonomic nerves that innervate the muscles of the bladder, urethral sphincter, and pelvic floor fasciae. Bladder dysfunction increases the rates of urinary tract infection, hospital visits or admission, and patient dissatisfaction. In addition, bladder dysfunction can also negatively impact patient quality of life (QoL). Several postoperative interventions have been proposed to prevent bladder dysfunction following radical hysterectomy. To our knowledge, there has been no systematic review evaluating the effectiveness and safety of these interventions for preventing bladder dysfunction following radical hysterectomy in women with cervical cancer.
To evaluate the effectiveness and safety of postoperative interventions for preventing bladder dysfunction following radical hysterectomy in women with early-stage cervical cancer (stage IA2 to IIA2).
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 4) in the Cochrane Library, MEDLINE via Ovid (1946 to April week 2, 2020), and Embase via Ovid (1980 to 2020, week 16). We also checked registers of clinical trials, grey literature, conference reports, and citation lists of included studies.
We included randomised controlled trials (RCTs) evaluating the effectiveness and safety of any type of postoperative interventions for preventing bladder dysfunction following a radical hysterectomy in women with stage IA2 to IIA2 cervical cancer.
Two review authors independently selected potentially relevant RCTs, extracted data, assessed risk of bias, compared results, and made judgments on the quality and certainty of the evidence. We resolved any disagreements through discussion or consultation with a third review author. Outcomes of interest consisted of spontaneous voiding recovery one week after the operation, quality of life (QoL), adverse events, post-void residual urine volume one month after the operation, urinary tract infection over the one month following the operation, and subjective urinary symptoms.
We identified 1464 records as a result of the search (excluding duplicates). Of the 20 records that potentially met the review criteria, we included five reports of four studies. Most of the studies had unclear risks of selection and reporting biases. Of the four studies, one compared bethanechol versus placebo and three studies compared suprapubic catheterisation with intermittent self-catheterisation. We identified two ongoing studies. Bethanechol versus placebo The study reported no information on the rate of spontaneous voiding recovery at one week following the operation, QoL, adverse events, urinary tract infection in the first month after surgery, and subjective urinary symptoms for this comparison. The volume of post-void residual urine, assessed at one month after surgery, among women receiving bethanechol was lower than those in the placebo group (mean difference (MD) -37.4 mL, 95% confidence interval (CI) -60.35 to -14.45; one study, 39 participants; very-low certainty evidence). Suprapubic catheterisation versus intermittent self-catheterisation The studies reported no information on the rate of spontaneous voiding recovery at one week and post-void residual urine volume at one month following the operation for this comparison. There was no difference in risks of acute complication (risk ratio (RR) 0.77, 95% CI 0.24 to 2.49; one study, 71 participants; very low certainty evidence) and urinary tract infections during the first month after surgery (RR 0.77, 95% CI 0.53 to 1.13; two studies, 95 participants; very- low certainty evidence) between participants who underwent suprapubic catheterisation and those who underwent intermittent self-catheterisation. Available data were insufficient to calculate the relative measures of the effect of interventions on QoL and subjective urinary symptoms.
None of the included studies reported rate of spontaneous voiding recovery one week after surgery, time to a post-void residual volume of urine of 50 mL or less, or post-void residual urine volume at 6 and 12 months after surgery, all of which are important outcomes for assessing postoperative bladder dysfunction. Limited evidence suggested that bethanechol may minimise the risk of bladder dysfunction after radical hysterectomy by lowering post-void residual urine volume. The certainty of this evidence, however, was very low. The effectiveness of different types of postoperative urinary catheterisation (suprapubic and intermittent self-catheterisation) remain unproven.
Aue-Aungkul A
，Kietpeerakool C
，Rattanakanokchai S
，Galaal K
，Temtanakitpaisan T
，Ngamjarus C
，Lumbiganon P
... -
《Cochrane Database of Systematic Reviews》
The effect of clamping the indwelling urinary catheter before removal in cervical cancer patients after radical hysterectomy.
To determine the effect of clamping the indwelling urinary catheter before its removal on bladder reconditioning in patients with cervical cancer after radical hysterectomy.
It is suggested that indwelling urinary catheters should be clamped intermittently to fill the bladder and restore bladder function before removal. However, indwelling urinary catheter clamping showed no effect on bladder reconditioning according to some clinical studies.
Randomised controlled study.
A total of 210 patients with cervical cancer after type C radical hysterectomy were randomised on 1:2 into two groups. In the clamping group, indwelling urinary catheters were clamped intermittently for 48 hours before removal based on a bladder-training sheet, while in the control group, the indwelling urinary catheters were removed without clamping. The primary outcome of the study was the rate of recatheterisation. The secondary outcomes included residual urine volume 24 hours after removal, incidence of urinary tract infection and duration of recatheterisation.
Seventy patients were assigned to the clamping group and 128 to the control group with paralleled baseline characteristics. The days of the primary catheterisation (13·20 ± 0·79 vs. 13·38 ± 1·04) and the incidence of urinary tract infection (22·9% vs. 20·3%) had no significant differences between the two groups. Ten patients in the clamping group and 19 in the control group underwent recatheterisation, the incidence of which showed no significant difference (14·3% vs. 14·8%). The days of recatheterisation were not statistically different between the two groups (11·40 ± 6·75 vs. 9·42 ± 5·23). However, the residual urine volume 24 hours after removal was higher in the clamping group than that in the control group.
Bladder recondition through indwelling urinary catheter clamping may not restore bladder function in patients after radical hysterectomy.
As indwelling urinary catheter clamping may increase the residual urine volume after indwelling urinary catheter removal and lead to an increased nursing workload, it should not be recommended in patients with cervical cancer postoperatively.
Gong Y
，Zhao L
，Wang L
，Wang F
... -
《-》
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