Voiding dysfunction complicates 21–42% of pelvic reconstructive procedures.1,2 Patients with failed voiding trials after pelvic reconstructive surgery are commonly discharged home with temporary catheterization until a repeat voiding trial is performed in the office. Although catheterization is short in duration,3–5 it is a large stressor for patients, and is often considered the worst part of the surgical experience and even a surgical complication.6,7
Traditionally, transurethral catheters continuously drain into a bag and are associated with increased rates of urinary tract infection (UTI) and patient discomfort and decreased patient satisfaction.8 Alternatives include suprapubic catheters, clean intermittent self-catheterization, and catheter valves. Suprapubic catheters and clean intermittent self-catheterization have lower infection risks and are more preferred by patients compared with transurethral catheters.3,9 Clean intermittent self-catheterization requires adequate manual dexterity to perform; and suprapubic catheters require surgical placement. Catheter valves were introduced in 1986,8 marketed to help maintain bladder tone and capacity,10 and linked to decreased rates of UTI and catheter encrustation8,11 with increased patient satisfaction.5
A variation in management is manual intermittent catheter plugging and unplugging (plug–unplug) (Fig. 1). The transurethral catheter is occluded with a plastic plug and unplugged to empty the bladder. Plug–unplug catheters allow patients to intermittently drain the bladder without a leg bag that potentially limits mobility and performance of activities of daily living (ADL).
The plug–unplug method has been routinely used in our practice and not previously evaluated or compared with other methods. Our primary objective was to compare the effects on activity of plug–unplug catheters to transurethral catheters with a continuous drainage bag. We hypothesized that activity would differ between groups.
This was a randomized controlled trial of two transurethral catheter management systems in women undergoing pelvic reconstructive surgery. Participants were recruited at the Hartford Hospital Division of Urogynecology during preoperative consultation between February 2017 and September 2018. Hartford HealthCare Institutional Review Board approval (HHC-2016-0228) was obtained before initiation of the study. The trial was registered at ClinicalTrials.gov (#NCT03071211), and CONSORT (Consolidated Standards of Reporting Trials) guidelines were followed.12
Women aged 18–89 years who were undergoing inpatient surgery for prolapse with or without a concomitant incontinence procedure were eligible to participate. Patients were excluded if the procedure involved planned postoperative catheter use, suprapubic catheter placement, urethral bulking, OnabotulinumtoxinA injection, a posterior vaginal repair alone, mesh excision, excision of fistula, or urethral diverticulum. Patients discharged to nursing facilities, those with limited manual dexterity due to arthritis or other musculoskeletal disorder, and those with a history of a neurologic condition affecting urinary function such as Parkinson's disease, spinal cord injury, or multiple sclerosis were also excluded.
Before hospital discharge, all patients underwent a standardized inpatient voiding trial as follows: with the patient standing all urine was drained from the bladder into the drainage bag and, after repositioning in dorsal supine position, the bladder was retrograde filled with 300 mL of sterile water or until the patient felt the urge to void. The catheter then was removed, and the patient was instructed to spontaneously void within 10 minutes of removal. Voiding trial failure was defined as voiding less than two thirds of the volume instilled with a postvoid residual volume (PVR) greater than one third of the volume instilled.
Participants were randomized at enrollment 1:1 to one of two arms: continuous drainage or plug–unplug. Treatment allocation was made by a computer-generated random numbers table with permuted blocks of four and assigned at the time of patient consent. The surgical team was not blinded to group allocation. Patients randomized to the catheters' arms did not receive antibiotics during catheterization; however, all patients in the study received appropriate preoperative antibiotics, redosed if needed, per the guidelines. The catheter arms had a 16-French transurethral catheter attached to either a leg bag (continuous drainage arm) or capped with a plastic plug (plug–unplug arm) and instructed to uncap when they felt the urge to void or, in the absence of urge, at least every 4 hours (Fig. 1). Patients in both arms were provided a large drainage bag for gravity-based drainage for overnight use. Participants enrolled and randomized who passed the inpatient voiding trial, and therefore did not require a catheter, were assigned to a reference arm, which was assessed using the same preoperative and postoperative questionnaires as the catheter arm. This reference arm of participants acted as a control for the effect of a transurethral catheter alone on postoperative mobility. Once the reference arm reached the predetermined enrollment requirement, any subsequent patient who was enrolled in the study but passed her inpatient voiding trial was excluded.
All participants discharged home with a catheter were scheduled for an outpatient voiding trial between postoperative days 5 and 7, following the same protocol as the inpatient voiding trial. At the time of their outpatient voiding trials, a urinalysis was performed and urine was sent for culture only if patients reported symptoms of UTI consistent with clinical practice. Patients were treated for UTI based on culture results or if there was high clinical suspicion during office follow-up. Patients with a failed outpatient voiding trial were discharged home with bladder drainage per standard of care and underwent routine follow-up until they passed a repeat office voiding trial. Standard of care for failed outpatient voiding trial included one of three options: continuous drainage, plug–unplug, or clean intermittent self-catheterization. All participants were followed for 3 months from initial surgery; however, no additional research-associated visits were necessary beyond the initial outpatient voiding trial.
The primary outcome was activity measured by difference in scores between arms on the activity assessment scale as described by McCarthy et al13 and validated in pelvic reconstructive patients by Barber et al14 The activity assessment scale consists of 13 items and is subdivided into three subscales: sedentary activities, ambulatory activities, and work or exercise activities (Appendix 1, available online at http://links.lww.com/AOG/B590). The total activity assessment scale score can range from 0 to 100 with higher scores reflecting better mobility. Secondary outcomes were the rate of UTI, time to passing outpatient voiding trial in days, postoperative pain, patient satisfaction and catheter effect.
Participants completed a series of surveys at their preoperative visit and 5–7 days postoperatively. All participants had the option to complete questionnaires in-person, via telephone or electronic mail. The activity assessment scale was completed at both time points. Preoperatively, questions regarding patient's expectations on surgical recovery also were assessed using a previously published questionnaire by Tunitsky-Bitton et al4 The postoperative interview included questions regarding patient satisfaction4 and pain and catheter assessment (Fig. 2). Patient satisfaction was assessed by “How satisfied are you with the surgery and recovery?” Possible responses were “very,” “somewhat” or “not satisfied.” The postoperative pain assessment included questions addressing overall pain and pain specific to the urethra on an eleven-point scale with 0 equaling no pain and 10 equaling severe pain. The pain questionnaire regarding required use of narcotic and nonnarcotic pain medication after surgery included the responses: “around the clock as prescribed,” “occasionally, less frequently than prescribed,” “do not take because my pain is minimal,” and “do not take because I do not tolerate narcotics.”
The primary outcome was activity measured by difference in scores between arms on the activity assessment scale. Secondary outcomes included rate of UTI, time to passing outpatient voiding trial in days, postoperative pain, patient satisfaction and catheter effect. Ninety participants in three groups of 30 provided more than 80% power to detect an effect size of 0.33 using a 2-df χ2 test at α=0.05. To evaluate the combined outcomes of catheter compared with no catheter, sample sizes of 60 (use of a catheter) and 30 (reference) afforded 81% power to detect a difference in proportions of 0.30. Assuming a 5% attrition rate, we sought to enroll 96 participants (32 per arm). All analyses were performed using the intent-to-treat principle.
Baseline characteristics were reported using descriptive and inferential statistics. For the primary outcome, effect on activity using the activity assessment scale, two analyses were performed. The first assessed whether there was a difference in activity assessment scale between arms, using an analysis of variance, with a post hoc Scheffé test, or a Kruskal-Wallis H test. The second analysis evaluated whether there was a difference between catheter compared with no catheter, using a t or Mann-Whitney U test. The activity assessment scale score was calculated as described by Barber et al14 (Appendix 1, http://links.lww.com/AOG/B590).
Continuous variables were compared using Wilcoxon rank sum test, and categorical variables were compared using Fisher exact tests and Pearson's χ2. Length of stay and duration of catheterization was evaluated with a Kruskal-Wallis H test. Pain and patient satisfaction were evaluated for normality and analyzed as described for the primary outcome.
Statistical analyses used SPSS 21 at α=0.05, such that P<.05 was deemed significant.
The study included 93 women. The first 30 patients who did not require postoperative catheterization were included in the reference arm; 32 were randomized to plug–unplug and 31 to continuous drainage (Tables 1 and 2). Study flow is outlined in Figure 3. The catheterization rate within the cohort was 23% (63/277).
There was no postoperative difference in activity assessment scale scores between catheter arms (total score: plug–unplug 70.3, continuous drainage 67.7, reference arm 79.4; P=.090; Table 3). The evaluation performed postsurgical days 5–7 is reported in Table 4. For secondary outcomes, there was no difference in overall satisfaction with the surgery and recovery between arms, with the majority reporting they were “very satisfied” (plug–unplug 78.1%, continuous drainage 80.0%, reference 66.7%, P=.202). Participants in the continuous drainage arm had a higher percentage (P=.048) of postoperative visits (36.7%) with health care practitioners compared with the reference arm (10.0%) but no difference (P=.266) compared with the plug–unplug arm (21.9%). There was no difference in overall pain between arms (plug–unplug 5.8±2.3, continuous drainage 5.7±2.2, reference 4.4±3.0, P=.073). Patients in the catheter arms had more urethral pain compared with the reference arm (plug–unplug 2 [1–6], continuous drainage 3.3 [1.9–5.5], reference 1.5 [0–3], P=.023). There was no difference between plug–unplug and continuous drainage arms in percentage who used narcotic (χ2P=.531) or nonnarcotic (χ2P=.749) pain medication.
The majority of patients passed their outpatient voiding trial at the initial postoperative visit (plug–unplug 71.9%, continuous drainage 58.1%, P=.250). Participants in the plug–unplug arm had a significantly higher voided volume (plug–unplug 261±133 mL, continuous drainage 187±126 mL, P=.027) and lower PVR (plug–unplug 775±143 mL, continuous drainage 114±123 mL, P=.035) compared with participants with continuous drainage catheters. Women in the continuous drainage arm had significantly more difficulties managing their catheter compared with the plug–unplug arm (Table 4).
No patients underwent postoperative transfusions. Five patients had a return to the operating room within 3 months after index surgery. One patient in the plug–unplug arm had persistent buttock pain after sacrospinous ligament fixation that was initially managed with readmission and pain management modification; the patient ultimately underwent suture removal on postoperative day 6, with complete resolution of symptoms. Four patients in the continuous drainage arm had persistent postoperative voiding dysfunction that required sling revision between postoperative days 30 and 49. There were three readmissions within the 3-month follow-up period. In addition to the plug–unplug patient readmitted for persistent buttock pain, a patient in the continuous drainage arm was readmitted 3 days postoperatively for persistent nausea and emesis and diagnosed with gastritis. Another for whom outpatient management failed received intravenous antibiotics for superficial skin infection. One patient in the reference arm who initially passed the inpatient voiding trial returned on postoperative day 3 with urinary retention requiring catheter placement in the office and subsequently passed the voiding trial 10 days after surgery.
Compared with the reference arm, patients in the catheter arms had higher frequencies of lower urinary tract symptoms (plug–unplug 71.0%, continuous drainage 48.4%, reference 13.3%, P<.001), urine cultures sent (plug–unplug 84.4%, continuous drainage 54.8%, reference 10.0%, P<.001) and treatment for UTI (plug–unplug 75%, continuous drainage 51.6%, reference 6.7%, P<.001). Urine cultures were sent more often in the plug–unplug arm than the continuous drainage arm (plug–unplug 84.4%, continuous drainage 54.8%, P=.014); however, there was no difference between plug–unplug and continuous drainage arms in the percentage of women reporting lower urinary tract symptoms (plug–unplug 71%, continuous drainage 48.4%, P=.120) or treatment for UTI (plug–unplug 75%, continuous drainage 51.6%, P=.070). Overall, 58.7% of patients with postoperative catheters had culture-positive UTI compared with 6.7% of patients without catheters (P<.001). There was no difference in culture-positive UTI between patients with plug–unplug catheters and continuous drainage catheters (plug–unplug 68.8%, continuous drainage 48.4%, P=.625).
The preoperative evaluation assessing patient expectations showed that 62.4% of the total cohort regarded going home without a catheter to be “greatly important” (plug–unplug 65.6%, continuous drainage 48.4%, reference 73.3%, P=.482). Postoperatively, when asked, “What was the worst part of your experience with the surgery and recovery?” 18.3% patients reported the catheter. An additional 28.0% reported pain control; 19.4% reported constipation; 110.8% were not satisfied with the overall hospital experience; 4.3% had anxiety about the surgery and recovery and 3.2% found the postsurgical effect on activity to be the worst part of the experience.
Postoperative catheterization is common after pelvic reconstructive surgery and can be burdensome for patients' postoperative experience. Our study found no difference in activity between patients discharged with plug–unplug and continuous drainage catheters. However, patients with a plug–unplug catheter perceived less difficulty with managing the catheter and performing ADL compared with those with a continuous drainage catheter—a finding consistent with studies on catheter valves.5 We found that 62% of patients considered going home without a catheter important and that, postoperatively, 18% of the cohort considered the catheter to be the worst part of the surgical experience, which supports prior studies on patient-centered outcomes.6,7 Providing patients with a catheterization technique that is easier to manage may decrease the catheter burden and improve patient experience.
Pain and activity were similar between patients discharged with and without a catheter, regardless of the type of catheterization. This finding is valuable and should be used in preoperative counseling. The majority of our cohort underwent vaginal and laparoscopic surgeries—routes associated with low postoperative pain levels and narcotic use.15–17 Addition of a catheter likely had minimal effect on overall postoperative pain and activity. We used the validated activity assessment scale after pelvic reconstructive surgery, although it may not have captured differences in activity during the first week postoperatively. Some participants had not attempted some of the activities comprising the scale. Although we anticipated this possibility a priori, we were looking for a patient-centered outcome, because we hypothesized that the choice of catheter was unlikely to affect any clinical outcomes but may demonstrate difference in the patient's mobility or satisfaction or both. We specifically chose to use the activity assessment scale owing to its use in prior studies and validation in urogynecologic population. Additionally, the three subscales allowed for additional comparisons based on the type of activity (eg, sedentary, ambulatory, or work or exercise).
The rate of voiding trial failure in our study (23%) is similar to previously reported rates after prolapse repair.1,2 Our standard of care is to schedule outpatient voiding trial 5–7 days postoperatively (the median in this study was 7). Interestingly, patients in the plug–unplug arm had significantly higher voided volumes and almost half of the PVR at that time compared with the continuous drainage arm. Theoretically, intermittently filling and emptying of the bladder can allow bladder training in patients requiring catheterization, similar to catheter valves.10 Although previous studies exploring this hypothesis have shown conflicting results,3,18–20 given the differences in voiding efficiency between the plug–unplug and continuous drainage arms, it is possible that patients in plug–unplug arm could have undergone a voiding trial sooner. All patients were scheduled at the same time point, and, therefore, we could not demonstrate this difference.
Independent of plug–unplug or continuous drainage arm, almost 60% of patients discharged with a catheter had a culture-positive UTI in the 3-month postoperative period, compared with the 13% without a catheter. The incidence of UTI in our sample is higher than previously published studies.3–5 A meta-analysis of RCTs involving catheterized patients showed that transurethral catheters have a higher risk of UTI when duration of catheterization is greater than 5 days, but no difference from suprapubic catheters and clean intermittent self-catheterization if duration is no more than 5 days.20 The longer median duration of catheterization may have contributed to our increased rate of UTI. There may have been selection bias, because those discharged with a catheter had an additional visit for a repeat voiding trial and were more likely to be assessed for urinary symptoms and have a urine culture sent than were patients without a catheter. Positive urinary cultures in catheterized patients may represent bacterial colonization. Additionally, unlike prior studies,4,5 we did not limit the diagnosis of UTI to the duration of the catheterization and encompassed the 3-month follow-up period. We found no difference in positive cultures or treatment for UTI between the catheter arms, despite the theoretical concern that plugging and unplugging a catheter disrupts the closed catheter system, thus increasing the risk of infection. However, we were not powered to detect this difference.
Strengths of the study include its prospective, randomized design, and clearly defined cohort of patients undergoing varied routes of surgery for prolapse and incontinence. The cohort had excellent follow-up data and included a reference arm not needing catheterization. The primary outcome was based on a questionnaire validated for use in this population.
Timing of the postoperative activity assessment scale may have affected the scoring as it was administered between postoperative days 5–7 when patients are commonly instructed to restrict some of the activities assessed by the survey. Additional limitations include being underpowered for the secondary outcomes and the inability to blind participants or surgeons.
Although we did not find a difference in postoperative activity between the plug–unplug and continuous drainage catheters based on the activity assessment scale scores, we also did not find a difference compared with women discharged without a catheter, emphasizing the low effect of catheters on activity after urogynecologic surgery. Patients with plug–unplug catheters found the management easier and less prohibitive regarding ADL. They also had higher outpatient voided volumes and lower PVR, which may call for earlier implementation of repeat voiding trial. There were no adverse events associated with this method in our small cohort, including no increase in UTI rate. With the current focus on patient-centered outcomes it is important to continue to evaluate various postoperative management practices that may enhance patient recovery or satisfaction. Given significant anxiety associated with requiring a catheter postoperatively, offering patients options when it comes to the catheter management is valuable. Plug–unplug catheter management technique is an acceptable method that does not appear to cause adverse events and may be considered for short-term catheterization after pelvic reconstructive surgery.
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