Abstract
To assess complications of condom catheters compared to indwelling urethral catheters, we conducted a prospective cohort study in 2 Veterans Affairs hospitals. Male patients who used a condom catheter or indwelling urethral catheter during their hospital stay were followed for 1 month by interview and medical record review. Participants included 36 men who used condom catheters and 44 who used an indwelling urethral catheter. At least one catheter-related complication was reported by 80.6% of condom catheter users and 88.6% of indwelling catheter users (P=.32) with non-infectious complications (e.g., leaking urine, pain or discomfort) more common than infectious complications in both groups. Condom catheter patients were significantly less likely than indwelling catheter patients to report complications during catheter placement (13.9% vs 43.2%, P<.001). Patients reported approximately three times more non-infectious complications than those recorded in the medical record.
INTRODUCTION
Millions of patients use urinary collection devices. For men, both indwelling and condom-style urinary catheters (known as “external catheters”) are commonly used. National infection prevention guidelines recommend condom catheters as a preferred alternative to indwelling catheters for patients without urinary retention1,2 to reduce catheter-associated urinary tract infection (UTI) risk. Unfortunately, little outcome data comparing condom catheters with indwelling urethral catheters exists. We therefore assessed the incidence of infectious and noninfectious complications in condom catheter and indwelling urethral catheter users.
Patients and METHODS
Study Overview
As part of a larger prospective observational study,3 we compared complications between patients who received a condom catheter during hospitalization to those who received an indwelling urethral catheter. Hospitalized patients with either a condom catheter or indwelling urethral catheter were identified at two Veterans Affairs (VA) medical centers and followed for 30 days after initial catheter placement. Patient reported data was collected during in-person patient interviews at baseline (within 3 days of catheter placement), and in-person or phone interviews at 14 days and 30 days post-placement (Supplementary Appendix A & B). Questions were primarily closed-ended, except for a final question inviting open comments. Information about the catheter and any reported complications was also collected from electronic medical record documentation for each patient. Institutional review board approval was received from both participating study sites.
Data Collection and Inclusion Criteria
Hospitalized patients who had a condom or indwelling urethral catheter placed were eligible to participate if they met the following criteria: 1) were hospitalized on an acute care unit; 2) had a new condom catheter or indwelling urethral catheter placed during this hospital stay that was not present on admission; 3) had a device in place for 3 days or less; 4) were at least 18 years old; and 5) were able to speak English. Patients were excluded if they: 1) did not have the capacity to provide self-consent or participate in the interview/assessment process; 2) refused to provide written informed consent to participate; or 3) had previously participated in this project.
As the larger study was focused on indwelling urethral catheter users, participants with a condom catheter were recruited from only one facility, while those with an indwelling urethral catheter were recruited from both hospitals. Indwelling catheter patients that had a possible contraindication to condom catheter use (such as urinary retention or perioperative use for a surgical procedure) were excluded to make the groups comparable. Any indication for condom catheterization was permitted.
Information about catheter-related complications was collected from two sources: directly from patients and through medical record review. Patients were interviewed at baseline, and approximately 14 days and 30 days after catheter placement. The follow-up assessments asked patients about their symptoms and experience over the previous 2 weeks. We also conducted a medical record review covering the 30-days post initial catheter placement.
Study Measures
A patient was considered to have an infectious complication in the medical record review if a medical professional documented a UTI (for condom catheter patients) or catheter-associated UTI (for indwelling urethral catheter patients) in the medical record. Patients who either 1) reported they were told they had a UTI; or 2) reported they had fever, chills, burning with urination, urinary frequency, urinary urgency, or other symptoms suggestive of an infection that required the patient to see a doctor were considered to have a self-reported infectious complication. Non-infectious complications included symptoms such as pain or discomfort, trauma, a sense of urgency or bladder spasms, blood in their urine, leaking urine after catheter removal, and difficulty with starting or stopping urine stream. Secondary outcomes focused on patient perspectives about their devices, including sexual function.
Data Analysis
The primary outcome was the percentage of patients who experienced a complication related to a urinary catheter during the 30 days after the catheter was initially placed. Comparisons by group – condom versus indwelling catheter – were conducted using Chi-square tests (Fisher’s exact test when necessary) for categorical variables and Student’s t-test for continuous variables. All analyses were performed using SAS (Cary, NC). All statistical tests were two-sided with alpha set to .05.
RESULTS
Of the 76 patients invited to participate after having a condom catheter placed, 49 consented (64.5%). Of those, 36 had sufficient data for inclusion in this analysis. The comparison group consisted of 44 patients with an indwelling urethral catheter. There were no statistically significant differences between the two groups in terms of age, race, or ethnicity (Table 1). There were statistically significant differences in patient-reported reason for catheter placement, but these are due to the exclusion criteria used for indwelling urethral catheter patients.
Table 1.
Study Participant Demographics and Baseline Characteristics (N=80)
| Characteristic | Condom Catheter, N (%) | Indwelling Urethral Catheter, N (%) | P value |
|---|---|---|---|
| Age in years, mean (SD) | 71.4 (11.8) | 70.7 (11.8) | .80a |
| Sex | |||
| Male | 36 (100) | 44 (100) | NA |
| Race | |||
| White | 31 (86.1) | 34 (77.3) | .84 |
| African American | 2 (5.6) | 6 (13.6) | |
| American Indian or Alaskan Native | 1 (2.8) | 1 (2.3) | |
| Other/Unknown | 2 (5.6) | 3 (6.8) | |
| Hispanic | 0 (0) | 3 (6.8) | .25 |
| Reason for Urethral Catheter Placement? | |||
| Incontinence | 10 (27.8) | 16 (36.4) | <.001b |
| Perioperative use for surgical procedureb | 11 (30.6) | 0 (0) | |
| Required prolonged immobilization | 5 (13.9) | 11 (25.0) | |
| Accurate measurement of urine output | 2 (5.6) | 17 (38.6) | |
| Urinary retention or bladder obstructionb | 1 (2.8) | 0 (0) | |
| Other or unknownb | 7 (19.4) | 0 (0) | |
| Urinary Catheter Duration of 3 days or less | 29 (80.6) | 36 (81.8) | .89 |
P-value calculated with t-test
Patients that self-reported an indwelling urethral catheter placed for perioperative use for surgical procedure, urinary retention or bladder obstruction, or other were intentionally excluded from this analysis since it could be inappropriate to use a condom catheter in some of those patients. We did not, however, drop any patients from the condom catheter group based on their self-reported indication for placement.
Outcomes, both patient-reported and clinician-reported (i.e., recorded in the patient’s medical record) are described in Table 2. In total, 80.6% of condom catheter users reported experiencing at least one catheter-related complication during the month after initial catheter placement compared with 88.6% of indwelling catheter users (P=.32). A similar number of condom catheter patients and indwelling urethral catheter patients experienced an infectious complication based on both self-report (8.3% condom, 6.8% indwelling; P=.99) and medical record review (11.1% condom, 6.8% indwelling; P=.69).
Table 2:
Specific Complications Associated with Condom and Indwelling Urethral Catheter Use During Month after Catheter Placement
| Patient-Reported Complications | Complications in Medical Recorda | |||||
|---|---|---|---|---|---|---|
| Specific Complication | Condom Catheter, N (%) | Indwelling Urethral Catheter, N (%) | P value | Condom Catheter, N (%) | Indwelling Urethral Catheter, N (%) | P value |
| Infectious Complication | 3 (8.3) | 3 (6.8) | .99 | 4 (11.1) | 3(6.8) | .69 |
| Fevers, chills, burning with urination, urinary frequency, urgency, or other symptoms suggestive of an infection that required you to see a doctor | 2 (5.6) | 3 (6.8) | .99 | |||
| Told they had a urinary tract infection | 3 (8.3) | 2 (4.6) | .65 | |||
| Documented urinary tract infectionb | 4 (11.1) | 3 (6.8) | .69 | |||
| Non-Infectious Complication | 27 (75.0) | 38 (86.4) | .20 | 9 (25.0) | 12 (27.3) | .82 |
| Pain, discomfort, bleeding, or other trauma during urinary catheter insertion | 5 (13.9) | 19 (43.2) | <.001 | |||
| Pain or burning when you urinatec | 4 (12.1) | 10 (23.3) | .21 | 0 (0) | 1 (2.3) | .99 |
| Pain or swelling in scrotumc | 1 (3.1) | 11 (25.6) | .009 | |||
| Pain or discomfort (not otherwise specified) | 2 (5.6) | 3 (6.8) | .99 | 0 (0) | 3 (6.8) | .25 |
| Pain, discomfort, bleeding, or other trauma during urinary catheter removalc | 9 (40.9) | 8 (42.1) | .99 | |||
| Difficulty with starting or stopping your urine streamc | 13 (40.6) | 12 (27.9) | .25 | 1 (2.8) | 2 (4.5) | .99 |
| Urgency or bladder spasms | 11 (30.6) | 15 (34.1) | .74 | |||
| Leaking urinec | 9 (27.3) | 15 (34.9) | .48 | 5 (13.9) | 3 (6.8) | .46 |
| Split or spraying stream of urinec | 8 (24.2) | 14 (32.6) | .43 | |||
| Blood in urine | 1 (2.8) | 7 (15.9) | .07 | 1 (2.8) | 6 (13.6) | .12 |
| Sexual problemsc | 4 (12.5) | 2 (4.7) | .39 | |||
| Urinary retentionc | 2 (5.6) | 4 (9.1) | .69 | |||
| Inadvertent removal | 2 (5.6) | 0 (0) | .20 | 2 (5.6) | 0 (0) | .19 |
| Other device related complication | 8 (23.5) | 9 (20.5) | .74 | 2 (5.6) | 2 (4.5) | .99 |
| Total Infectious and Non-Infectious Complicationsd | 27 (75.0) | 38 (86.4) | .20 | 12 (33.3) | 14 (31.8) | .89 |
The patients identified as having a complication through patient report were often different from the patients identified through medical record review. For example, two patients with an indwelling urinary catheter were identified by both self-report and medical record review as having an infectious complication, however only one patient with a condom catheter was identified as having an infectious complication using both methods.
The following definition was used for UTI documented in the medical record: “Any explicit statement of a diagnosis of UTI by a medical professional documented in the medical record as occurring after the use of a urinary catheter.
These complications were assessed only for patients if they no longer had a catheter in place. All other complications were assessed in all patients, both with and without a current urinary catheter.
For patient reported outcomes, all the patients that reported an infectious complication also reported a non-infectious complication. As a result, the total for both infectious and non-infectious complications is the same as for only non-infectious complications.
Combining self-report and medical record review data resulted in 77.8% of condom catheter patients (28 of 36) and 88.6% of indwelling urethral catheter patients (39 of 44) having at least one identified non-infectious complication (P=.19); most based on self-report. Significantly fewer condom catheter patients reported complications during placement (e.g., pain, discomfort, bleeding or other trauma) compared to those with indwelling catheters (13.9% vs 43.2%, P<.001). Pain, discomfort, bleeding, or other trauma during catheter removal were commonly reported by both condom catheter and indwelling urethral catheter patients (40.9% vs. 42.1%, respectively; P=.99).
Patient-reported non-infectious complications were often not documented in the medical record: 75.0% of condom catheter patients and 86.4% of indwelling catheter patients reported complications, in comparison to the 25.0% of condom catheter and 27.3% of indwelling urethral catheter patients with non-infectious complications identified during medical record review.
DISCUSSION
Our study revealed three important findings. First, non-infectious complications greatly outnumbered infectious complications, regardless of device type. Second, condom catheter users reported significantly less pain related to placement of their device compared to the indwelling urethral catheter group. Finally, many patients reported complications that were not documented in the medical record.
The only randomized trial comparing these devices enrolled 75 men hospitalized at a single VA medical center, and found that using a condom catheter rather than an indwelling catheter in patients without urinary retention lowered the composite endpoint of bacteriuria, symptomatic UTI, or death.4 Additionally, patients in this trial reported that the condom catheter was significantly more comfortable (90% vs 58%; P=.02) and less painful (5% vs 36%; P=.02) than the indwelling catheter,4 supporting a previous study in hospitalized male Veterans.5
Importantly, we included patient-reported complications that may be of concern to patients, but inconsistently documented in the medical record. Pain associated with removal of both condom catheters and indwelling urethral catheters was reported in over 40% in both groups but was not documented in the medical record. One patient with a condom catheter described removal this way: “It got stuck on my hair, so was hard to get off…” Condom catheters also posed some issues with staying in place as has been previously described.6 As one condom catheter user said: “When I was laying down it was okay, but every time I moved around…it would slide off.”
Recent efforts to reduce catheter-associated UTI,7–9 which have focused on reducing the use of indwelling urethral catheters,10,11 have been relatively successful. Clinical policy-makers should consider similar efforts to address the non-infectious harms of both catheter types. Such efforts could include further decreasing any type of catheter use along with improved training of those placing such devices.12 Substantial improvement will require a systematic approach to surveilling non-infectious complications of both types of urinary catheters.
Our study has several limitations. First, we conducted the study at two VA hospitals and thus may not be generalizable to a non-VA population. Second, we only included 80 patients since we recruited a limited number of condom catheter users. Third, while we tried to compare 2 similar groups of patients it is possible that the indwelling catheter patients had greater morbidity, which necessitated use of an indwelling catheter instead of a condom catheter. Finally, we found a large discrepancy between what our patients reported compared to medical record review. While complications reported by the patient may not constitute a medically defined complication, due to the well-known phenomenon of poor documentation of catheter complications in general13 we believe what patients report is important for understanding the full scope of potential problems.
Limitations notwithstanding, we provide comparison data between condom and indwelling urethral catheters. Condom catheter users reported significantly less pain related to initial placement of their device compared to those using an indwelling urethral catheter. For both devices, patients experienced non-infectious complications much more commonly than infectious ones, underscoring the need to systematically address such complications perhaps through a surveillance system that includes the patient’s perspective. The patient’s voice is important and necessary since non-infectious harms appear to be under-reported in the medical record.
Supplementary Material
Acknowledgements
The authors thank the following individuals who assisted with data collection for the study: Laura Dillon, Jeanaya McKinley, Laura Peña, Jason Mann, Marylena Rouse, Kathy Swalwell, Suzanne Winter, Jane Wong, and Debbie Zawol.
Grant Support
This study was funded by the Department of Veterans Affairs, Health Services Research & Development Service (Grant: IIR 12-395 and RCS 11-222).
Potential Competing Interests
Dr. Saint reports serving on the medical advisory board for Doximity (a social networking site for physicians), and on the scientific advisory board of Jvion (a health care technology company). In addition, Dr. Saint has a provisional patent pending on a product to improve aseptic placement of urinary catheters, unrelated to this manuscript. Dr. Saint has no associations with any companies or manufacturers, has no ownership in a commercial entity, and receives no royalties for this pending patent. Dr. Trautner reports receiving the following funding unrelated to this manuscript: grant support from Zambon Pharmaceuticals, as well as consultant fees from Zambon Pharmaceuticals and Paratek Pharmaceuticals.
Footnotes
Disclaimer: The funding sources played no role in the design, conduct or evaluation of this study. The findings and conclusions in this manuscript are those of the authors and do not necessarily represent the official position of the Department of Veterans Affairs.
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